Content uploaded by Henry A Pitt
Author content
All content in this area was uploaded by Henry A Pitt
Content may be subject to copyright.
J Hepatobiliary Pancreat Surg (2007) 14:1–10
DOI 10.1007/s00534-006-1150-0
Background: Tokyo Guidelines for the management of acute
cholangitis and cholecystitis
Tadahiro Takada1, Yoshifumi Kawarada2, Yuji Nimura3, Masahiro Yoshida1, Toshihiko Mayumi4,
Miho Sekimoto5, Fumihiko Miura1, Keita Wada1, Masahiko Hirota6, Yuichi Yamashita7, Masato Nagino3,
Toshio Tsuyuguchi8, Atsushi Tanaka9, Yasutoshi Kimura10, Hideki Yasuda11, Koichi Hirata10,
Henry A. Pitt12, Steven M. Strasberg13, Thomas R. Gadacz14, Philippus C. Bornman15, Dirk J. Gouma16,
Giulio Belli17, and Kui-Hin Liau18
1
Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
2
Mie University School of Medicine, Mie, Japan
3
Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan
4
Department of Emergency Medicine and Intensive Care, Nagoya University School of Medicine, Nagoya, Japan
5
Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine, School of Public Health,
Kyoto, Japan
6
Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical Science, Kumamoto, Japan
7
Department of Surgery, Fukuoka University Hospital, Fukuoka, Japan
8
Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan
9
Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan
10 First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo, Japan
11 Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan
12 Department of Surgery, Indiana University School of Medicine, Indianapolis, USA
13 Department of Surgery, Washington University in St Louis and Barnes-Jewish Hospital, St Louis, USA
14 Department of Gastrointestinal Surgery, Medical College of Georgia, Georgia, USA
15 Division of General Surgery, University of Cape Town, Cape Town, South Africa
16 Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands
17 General and HPB Surgery, Loreto Nuovo Hospital, Naples, Italy
18 Department of Surgery, Tan Tock Seng Hospital / Hepatobiliary Surgery, Medical Centre, Singapore
work required more than 20 meetings to obtain a consensus
on each item from the working group. Then four forums were
held to permit examination of the Guideline details in Japan,
both by an external assessment committee and by the working
group participants (version 2). As we knew that the diagnosis
and management of acute biliary infection may differ from
country to country, we appointed a publication committee and
held 12 meetings to prepare draft Guidelines in English (ver-
sion 3). We then had several discussions on these draft guide-
lines with leading experts in the fi eld throughout the world,
via e-mail, leading to version 4. Finally, an International Con-
sensus Meeting took place in Tokyo, on 1–2 April, 2006, to
obtain international agreement on diagnostic criteria, severity
assessment, and management.
Key words Cholangitis · Cholecystitis · Charcot’s triad ·
Reynold’s pentad · Biliary drainage
Introduction
No guidelines focusing on the management of biliary
infection (cholangitis and cholecystitis) have previously
been published, and no worldwide criteria exist for
diagnostic and severity assessment. “Charcot’s triad”1 is
still used for the diagnosis of acute cholangitis. How-
Abstract
There are no evidence-based-criteria for the diagnosis, sever-
ity assessment, of treatment of acute cholecysitis or acute
cholangitis. For example, the full complement of symptoms
and signs described as Charcot’s triad and as Reynolds’ pen-
tad are infrequent and as such do not really assist the clinician
with planning management strategies. In view of these factors,
we launched a project to prepare evidence-based guidelines
for the management of acute cholangitis and cholecystitis that
will be useful in the clinical setting. This research has been
funded by the Japanese Ministry of Health, Labour, and Wel-
fare, in cooperation with the Japanese Society for Abdominal
Emergency Medicine, the Japan Biliary Association, and the
Japanese Society of Hepato-Biliary-Pancreatic Surgery. A
working group, consisting of 46 experts in gastroenterology,
surgery, internal medicine, emergency medicine, intensive
care, and clinical epidemiology, analyzed and examined the
literature on patients with cholangitis and cholecystitis in or-
der to produce evidence-based guidelines. During the investi-
gations we found that there was a lack of high-level evidence,
for treatments, and the working group formulated the guide-
lines by obtaining consensus, based on evidence categorized
by level, according to the Oxford Centre for Evidence-Based
Medicine Levels of Evidence of May 2001 (version 1). This
Offprint requests to: T. Takada
Received: May 31, 2006 / Accepted: August 6, 2006
2 T. Takada et al.: Background of Tokyo Guidelines
ever, these criteria were fi rst proposed in 1877 (level 4),
more than 100 years ago. Here, and throughout the se-
ries, levels of evidence are stated for referenced articles
in accordance with the Oxford Centre for Evidence-
Based Medicine Levels of Evidence of May 2001 (see
Table 1). However only 50%–70% of cholangitis pa-
tients present clinically with Charcot’s triad.2–8 In addi-
tion, Murphy’s sign9 (level 5) is useful (sensitivity of
50%–70% and specifi city of 79%–96%) in diagnosing
cholecystitis, and this sign is widely used in every coun-
try. Moreover, as many of the symptoms and concepts
of these diseases referred to in textbooks and reference
books vary from those originally stated, the issue of
worldwide criteria is problematic. In view of these un-
favorable situations, we considered it necessary to clar-
ify the defi nitions, concepts of disease, and treatment
methods for acute cholangitis and acute cholecystitis
and establish universal criteria that can be widely rec-
ognized and used.
A working group to establish practical Guidelines for
the Management of Cholangitis and Cholecystitis was
organized in 2003 (chief researcher, Tadahiro Takada).
This project was funded by a grant from the Japanese
Ministry of Health, Labour, and Welfare, and was sup-
ported by the Japanese Society for Abdominal Emer-
gency Medicine, the Japan Biliary Association, and the
Japanese Society of Hepato-Biliary-Pancreatic Surgery.
The working group consisted of physicians engaged in
gastroenterology, internal medicine, surgery, emer gency
medicine, intensive care, and clinical epidemiology as
the main members, and they started the work to prepare
the Guidelines.
As the research progressed, the group was faced with
the serious problem that high-level evidence regarding
the treatment of acute biliary infection is poor. There-
fore, an exective committee meeting was convened, and
the committee came to the following decision: the
Guidelines would be evidence-based in general, but
areas without evidence or with poor evidence (such as
diagnosis and severity assessment) should be completed
by obtaining high-level consensus among experts
worldwide.
We established a publication committee and held 12
meetings to prepare draft Guidelines in English (ver-
sion 3). Then we had several discussions on these draft
Guidelines with leading experts in the fi eld throughout
the world, via e-mail, leading to version 4. Finally,
an International Consensus Meeting took place in
Tokyo, on 1–2 April, 2006, to obtain international
agreement on diagnostic criteria, severity assessment,
and management.
We now publish the “Tokyo Guidelines for the
Management of Cholangitis and cholecystitis”. These
Guidelines consist of 13 articles, including “Discussion”
sections containing comments of attendees at the con-
sensus conference and analyses of audience voting at
the meeting.
We hope that these Guidelines will help their users
to give optimal treatment according to their own spe-
cialty and capability, and thus provide their patients
with the best medical treatment.
Background of Tokyo Guidelines
Biliary infections (acute cholangitis and cholecystitis)
require appropriate management in the acute phase.
Serious acute cholangitis may be lethal unless it is ap-
propriately managed in the acute phase. On the other
hand, although various diagnostic and treatment meth-
odologies have been developed in recent years, they
have not been assessed objectively and none of them
has been established as a standard method for the man-
agement of these diseases. We carried out an extensive
review of the English-language literature and found
that there was little high-level evidence in this fi eld, and
no systematically described practical manual for the
fi eld. Most importantly, there are no standardized diag-
nostic criteria and severity assessments for acute cholan-
gitis and cholecystitis, therefore, we would like to
establish standards for these items. The Tokyo Guide-
lines include evidence-based medicine and refl ect the
international consensus obtained through earnest dis-
cussions among professionals in the fi eld on 1–2 April,
2006, at the Keio Plaza Hotel, Tokyo, Japan. Concern-
ing the defi nitions in the practice guidelines, we have
applied to the Japanese Institute of Medicine: Commit-
tee to Advise the Public Health Service on Clinical
Practice Guidelines, to approve the systematically de-
veloped Guidelines to assist practioner and patient de-
cisions about appropriate healthcare for specifi c clinical
circumstances.
Notes on the use of the Guidelines
The Guidelines are evidence-based, with the grade of
recommendation also based on the evidence. The
Guidelines also present the diagnostic criteria for and
severity assessment of acute biliary infection. As the
Guidelines address so many different subjects, indices
are included at the end for the convenience of
readers.
The practice Guidelines promulgated in this work do
not represent a standard of practice. They are suggested
plans of care, based on best available evidence and the
consensus of experts, but they do not exclude other ap-
proaches as being within the standard of practice. For
example, they should not be used to compel adherence
to a given method of medical management, which meth-
T. Takada et al.: Background of Tokyo Guidelines 3
od should be fi nally determined after taking account
of the conditions at the relevant medical institution
(staff levels, experience, equipment, etc.) and the char-
acteristics of the individual patient. However, responsi-
bility for the results of treatment rests with those who
are directly engaged therein, and not with the consensus
group. The doses of medicines described in the text of
the Guidelines are for adult patients.
Methods of formulating the guidelines
With evidence-based medicine (EBM) as a core con-
cept, the Guidelines were prepared by the Research
Group on the Preparation and Diffusion of Guidelines
for the Management of Acute Cholangitis and Acute
Cholecystitis (chief researcher, Tadahiro Takada), un-
der the auspices of the Japanese Ministry of Health, La-
bour, and Welfare, and the Working Group for Guideline
Preparation, whose members were selected from ex-
perts in abdominal emergency medicine and epidemiol-
ogy by the Japanese Society for Abdominal Emergency
Medicine, the Japan Biliary Association, and the Japa-
nese Society of Hepato-Biliary-Pancreatic Surgery.
In principle, the preparation of the Guidelines pro-
gressed with the systematic search, collection, and as-
sessment of references for the objective extraction of
evidence. Next, the External Assessment Committee
examined the Guidelines. Then we posted the draft
guidelines on our website and had four open symposia,
bginning in September 2004, to gain feedback for fur-
ther review. Subsequently, a Publication Committee
was set up, and this committee had 12 meetings to pre-
pare draft Guidelines.
Re-examination of the draft Guidelines was then per-
formed, via e-mail, with experts on cholangitis and
cholecystitis throughout the world. After fi nal agree-
ment was reached at the International Consensus Meet-
ing, held in Tokyo in April 2006, “the Tokyo Guidelines
for the Management of Acute Cholangitis and Chole-
cystitis” were completed.
The process of extending the literature search
The literature was selected as follows: Using “cholangi-
tis” and “cholecystitis” as the medical subject heading
(MeSH; explode) or the key search words, approxim-
ately 17 200 items were selected from Medline (Ovid;
1966 to June 2003). These articles were subjected to a
further screening with “human” as the “limiting word”.
This screening provided 9618 items in English and in
Japanese. A further 7093 literature publications were
obtained from the Japana Centra Revuo Medicina
(inter net version), using “cholangitis”, “cholecystitis”,
and “biliary infection” as the key words, with further
screening with “human” as the “limiting word”. This
process provided 6141 items. After the titles and ab-
stracts of a total of 15 759 works were examined by two
committee members, 2494 were selected for a careful
examination of their full texts.
Other literature quoted in these selected works, to-
gether with works suggested by the specialist committee
members, were included in the examination.
To evaluate each article, a STARD (standards for
reporting of diagnostic accuracy) checklist (Table 1)12
was considered important. The purpose of this checklist
is to evaluate the format and study process, in order to
improve the accuracy and completeness of the reporting
of studies of diagnostic accuracy.
However, the STARD checklist is not suitable for
classifying various categories (e.g., therapy, prevention,
etiology, harm, prognosis, diagnosis, differential diag-
nosis, economic and decision analysis) and levels of evi-
dence. Therefore, in the Guidelines, the science-based
classifi cation used by the Cochrane Library (Table 2)
was adopted.
The evidence obtained from each item of reference
was evaluated in accordance with the science-based
classifi cation used by the Cochrane Library (Table 2),
and the quality of evidence for each parameter associ-
ated with the diagnosis and treatment of acute biliary
infection was determined. As stated above, the level of
evidence presented by each article was determined in
accordance with the Oxford Centre for Evidence-Based
Medicine Levels of Evidence (May 2001), prepared by
Phillips et al.13 (Table 2). The terms used in the catego-
ries are explained in the footnote to Table 2.
Categories of evidence and grading of recommendations
Based on the results obtained from these procedures,
grades of recommendation were determined, according
to the system for ranking recommendations in clinical
guidelines14–16 shown in Table 3, and mentioned, as re-
quired, in the text of the Guidelines. The grades of rec-
ommendation in the Guidelines are based on the Kish14
method of classifi cation and others.15,16 Recommenda-
tions graded “A” (that is, “do it”) and “B” (that is,
“probably do it”), are based on a high level of evidence,
whereas those graded “D” (that is, “probably don’t do
it”) or “E” (that is, “don’t do it”) refl ect a low level of
evidence.
Acknowledgments. We would like to express our deep
gratitude to the Japanese Society for Abdominal Emer-
gency Medicine, the Japan Biliary Association, and the
Japanese Society of Hepato-Biliary-Pancreatic Surgery,
who provided us with great support and guidance in the
preparation of the Guidelines. This process was con-
ducted as part of the project for the Preparation and
4 T. Takada et al.: Background of Tokyo Guidelines
Table 1. STARD checklist for the reporting of studies of diagnostic accuracy
Section and On page
topic Item no. no.
Title/Abstract/ 1 Identify the article as a study of diagnostic accuracy (recommend MeSH heading
Key words “sensitivity and specifi city”)
Introduction 2 State the research questions or study aims, such as estimating diagnostic accuracy
or comparing accuracy between tests or across participant groups
Methods Describe
Participants 3 The study population: the inclusion and exclusion criteria, setting and locations
where the data were collected
4 Participant recruitment: was recruitment based on presenting symptoms, results
from previous tests, or the fact that the participants had received the index tests
or the reference standard?
5 Participant sampling: was the study population a consecutive series of participants
defi ned by the selection criteria in items 3 and 4? If not, specify how participants
were further selected
6 Data collection: was data collection planned before the index test and reference
standard were performed (prospective study) or after (retrospective study)?
Test methods 7 The reference standard and its rationale
8 Technical specifi cations of material and methods involved, including how and when
measurements were taken, and/or cite references for index tests and reference
standard
9 Defi nition of and rationale for the units, cutoffs, and/or categories of the results of
the index tests and the reference standard
10 The number, training, and expertise of the persons executing and reading the index
tests and the reference standard
11 Whether or not the readers of the index tests and reference standard were blind
(masked) to the results of the other test, and describe any other clinical
information available to the readers
Statistical 12 Methods for calculating or comparing measures of diagnostic accuracy, and the
methods statistical methods used to quantify uncertainty (e.g., 95% confi dence intervals)
13 Methods for calculating test reproducibility, if done
Results Report
Participants 14 When study was done, including beginning and ending dates of recruitment
15 Clinical and demographic characteristics of the study population (e.g., age, sex
spectrum of presenting symptoms, comorbidity, current treatments, recruitment
centers)
16 The number of participants satisfying the criteria for inclusion that did or did not
undergo the index tests and/or the reference standard; describe why participants
failed to receive either test (a fl ow diagram is strongly recommended)
Test results 17 Time interval from the index tests to the reference standard, and any treatment
administered between
18 Distribution of severity of disease (defi ne criteria) in those with the target
condition; other diagnoses in participants without the target condition
19 A cross-tabulation of the results of the index tests (including indeterminate and
missing results) by the results of the reference standard; for continuous results,
the distribution of the test results by the results of the reference standard
20 Any adverse events from performing the index tests or the reference standard
Estimates 21 Estimates of diagnostic accuracy and measures of statistical uncertainty (e.g., 95%
confi dence intervals)
22 How indeterminate results, missing responses, and outliers of the index tests
were handled
23 Estimates of variability of diagnostic accuracy between subgroups of participants,
readers, or centers, if done
24 Estimates of test reproducibility, if done
Discussion 25 Discuss the clinical applicability of the study fi ndings
Adapted from reference 12
MeSH, medical subject heading; STARD, standards for reporting of diagnostic accuracy
T. Takada et al.: Background of Tokyo Guidelines 5
Table 2. Categories of evidence (refer to levels of evidence and grades of recommendations on the homepage of the Centre for Evidence-Based Medicine)
The science-based classifi cation used by the Cochrane Library: Oxford Centre for Evidence-based Medicine Levels of Evidence (May 2001) (http://www.cebm.net/levels_of_
evidence.asp#levels)13 was used as a basis to evaluate evidence presented in each article; the quality of evidence for each parameter associated with the diagnosis and treat-
ment of acute cholangitis and acute cholecystitis was determined
Differential
Therapy/prevention, diagnosis/symptom Economic and
Level aetiology/harm Prognosis Diagnosis prevalence study decision analyses
1a SR (with homogeneitya) SR (with homogeneitya) of SR (with homogeneitya) of SR (with homogeneitya) SR (with homogeneitya) of level 1
of RCTs inception cohort studies; level 1 diagnostic studies; of prospective cohort economic studies
CDRb validated in CDRb with 1b studies from studies
different populations different clinical centers
1b Individual RCT (with Individual inception Validatingd cohort study with Prospective cohort study Analysis based on clinically
narrow confi dence cohort study with >80% goode reference standards; or with good follow-upf sensible costs or alternatives;
intervalc) follow-up; CDRb validated CDRb tested within one systematic review(s) of the
in a single population clinical center evidence; and including
multi-way sensitivity analyses
1c All or noneg All or none case-series Absolute SpPins and SnNoutsh All or none case-series Absolute better-value or
worse-value analysesi
2a SR (with homogeneitya) SR (with homogeneitya) of SR (with homogeneitya) of level SR (with homogeneitya) SR (with homogeneitya) of level
of cohort studies either retrospective cohort >2 diagnostic studies of 2b and better studies >2 economic studies
studies or untreated
control groups in RCTs
2b Individual cohort study Retrospective cohort study Exploratoryd cohort study with Retrospective cohort study, Analysis based on clinically
(including low-quality RCT; or follow-up of untreated goode reference standards; or poor follow-up sensible costs or alternatives;
e.g., <80% follow-up) control patients in an RCT; CDRb after derivation, or limited review(s) of the
Derivation of CDRb or validated only on split-samplej evidence, or single studies; and
validated on split-samplej or databases including multi-way sensitivity
only analyses
2c “Outcomes” research; “Outcomes” research Ecological studies Audit or outcomes research
ecological studies
3a SR (with homogeneitya) SR (with homogeneitya) of 3b SR (with homogeneitya) SR (with homogeneitya) of 3b
of case-control studies and better studies of 3b and better studies and better studies
3b Individual case-control Non-consecutive study; or Non-consecutive cohort Analysis based on limited
study without consistently applied study, or very limited alternatives or costs, poor-quality
reference standards population estimates of data, but including
sensitivity analyses incorporating
clinically sensible variations
6 T. Takada et al.: Background of Tokyo Guidelines
Table 2. Continued
Differential
Therapy/prevention, diagnosis/symptom Economic and
Level aetiology/harm Prognosis Diagnosis prevalence study decision analyses
4 Case-series (and poor-quality Case-series (and Case-control study, poor or Case-series or superseded Analysis with no sensitivity analysis
cohort and case-control poor-quality prognostic non-independent reference reference standards
studiesk) cohort studiesl) standard
5 Expert opi\nion without Expert opinion without Expert opinion without explicit Expert opinion without Expert opinion without explicit
explicit critical appraisal, or explicit critical appraisal, critical appraisal, or based on explicit critical appraisal, or critical appraisal, or based on
based on physiology, bench or based on physiology, physiology, bench research, or based on physiology, bench economic theory or “fi rst principles”
research, or “fi rst principles” bench research, “fi rst principles” research, or “fi rst principles”
or “fi rst principles”
Users can add a minus-sign “−” to denote the level that fails to provide a conclusive answer because of: EITHER a single result with a wide confi dence interval (such that, for example, an ARR
in an RCT is not statistically signifi cant but whose confi dence intervals fail to exclude clinically important benefi t or harm) (Note #1), OR a systematic review with troublesome (and statistically
signifi cant) heterogeneity (Note #2). Such evidence is inconclusive, and therefore can only generate grade D recommendations (Note #3)
SR, Systematic review; RCT, Randomized controlled trial; ARR, absolute risk reduction
a By homogeneity, we mean a systematic review that is free of worrisome variations (heterogeneity) in the directions and degrees of results between individual studies. Not all systematic reviews
with statistically signifi cant heterogeneity need be worrisome, and not all worrisome heterogeneity need be statistically signifi cant. As noted above, studies displaying worrisome heterogeneity
should be tagged with a “−” at the end of their designated level
b Clinical decision rule. These are algorithms or scoring systems which lead to a prognostic estimation or a diagnostic category
c See note #2 for advice on how to understand, rate, and use trials or other studies with wide confi dence intervals
d Validating studies test the quality of a specifi c diagnostic test, based on prior evidence. An exploratory study collects information and trawls the data (e.g., using a regression analysis) to fi nd
which factors are “signifi cant”
e Good reference standards are independent of the test, and are applied blindly or objectively to all patients. Poor reference standards are haphazardly applied, but still independent of the test.
Use of a nonindependent reference standard (where the “test” is included in the “reference”, or where the “testing” affects the “reference”) implies a level 4 study
f Good follow-up in a differential diagnosis study is >80%, with adequate time for alternative diagnoses to emerge (e.g., 1–6 months, acute; 1–5, years, chronic)
g Met when all patients died before the Rx became available, but some now survive on it; or when some patients died before the Rx became available, but none now die on it
h An “absolute SpPin” is a diagnostic fi nding whose specifi city is so high that a positive result rules-in the diagnosis. An “absolute SnNout” is a diagnostic fi nding whose sensitivity is so high that
a negative result rules-out the diagnosis
i Better-value treatments are clearly as good but cheaper, or better at the same or reduced cost. Worse-value treatments are as good and more expensive, or worse and equally or more
expensive
j Split-sample validation is achieved by collecting all the information in a single tranche, then artifi cially dividing this into “derivation” and “validation” samples
k By poor-quality cohort study, we mean one that failed to clearly defi ne comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in
both exposed and nonexposed individuals, and/or failed to identify or appropriately control known confounders, and/or failed to carry out a suffi ciently long and complete follow-up of patients.
By poor-quality case-control study, we mean one that failed to clearly defi ne comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way
in both cases and controls and/or failed to identify or appropriately control known confounders
l By poor-quality prognostic cohort study, we mean one in which sampling was biased in favor of patients who already had the target outcome, or the measurement of outcomes was accomplished
in <80% of study patients, or outcomes were determined in an unblinded, nonobjective way, or there was no correction for confounding factors
Good, better, bad, and worse refer to the comparisons between treatments in terms of their clinical risks and benefi ts
T. Takada et al.: Background of Tokyo Guidelines 7
Diffusion of Guidelines for the Management of Acute
Cholangitis (H-15-Medicine-30), with a research sub sidy
for fi scal 2003 and 2004 (Integrated Research Project
for Assessing Medical Technology) sponsored by the
Japanese Ministry of Health, Labour, and Welfare.
We also truly appreciate the panelists who cooper-
ated with and contributed signifi cantly to the Interna-
tional Consensus Meeting held in Tokyo on April 1 and
2, 2006.
References
1. Charcot M. De la fi evre hepatique symptomatique. Comparaison
avec la fi evre uroseptique. Lecons sur les maladies du foie des
voies biliares et des reins. Pairs: Bourneville et Sevestre; 1877.
p. 176–85.
2. Boey JH, Way LW. Acute cholangitis. Ann Surg 1980;191:264–70.
(level 4)
3. O’Connor MJ, Schwartz ML, McQuarrie DG, Sumer HW. Acute
bacterial cholangitis: an analysis of clinical manifestation. Arch
Surg 1982;117:437–41. (level 4)
4. Lai EC, Tam PC, Paterson IA, Ng MM, Fan ST, Choi TK, et al.
Emergency surgery for severe acute cholangitis. The high-risk
patients. Ann Surg 1990;211:55–9. (level 4)
5. Haupert AP, Carey LC, Evans WE, Ellison EH. Acute suppura-
tive cholangitis. Experience with 15 consecutive cases. Arch Surg
1967;94:460–8. (level 4)
6. Csendes A, Diaz JC, Burdiles P, Maluenda F, Morales E. Risk
factors and classifi cation of acute suppurative cholangitis. Br J
Surg 1992;79:655–8. (level 2b)
7. Welch JP, Donaldson GA. The urgency of diagnosis and surgical
treatment of acute suppurative cholangitis. Am J Surg 1976;131:
527–32. (level 4)
8. Chijiiwa K, Kozaki N, Naito T, Kameoka N, Tanaka M. Treat-
ment of choice for choledocholithiasis in patients with acute
obstruc tive suppurative cholangitis and liver cirrhosis. Am J Surg
1995;170:356–60. (level 2b)
9. Murphy JB. The diagnosis of gall-stones. Am Med News
82:825–33.
10. Eskelinen M, Ikonen J, Lipponen P. Diagnostic approaches in
acute cholecystitis; a prospective study of 1333 patients with acute
abdominal pain. Theor Surg 1993;8:15–20. (level 2b)
11. Trowbridge RL, Rutkowski NK, Shojania KG. Does this patient
have acute cholecystitis? JAMA 289:80–6. (level 3b)
12. Bossuyt PM, Reitsma JB, Bruns DE, Glaziou CA, Irwig LM,
Lijmer JG, et al., for the STARD Group; STARD checklist for
the reporting of studies of diagnostic accuracy. Ann Int Med
2003;138:40-E-45.
13. Phillips B, et al. Levels of evidence and grades of recommendations
on the homepage of the Centre for Evidence-Based Medicine
(http://cebm.jr2.ox.ac.uk/docs/levels.html) 2001 revised version.
14. Kish MA; Infectious Diseases Society of America. Guide to de-
velopment of practice guidelines. Clin Infect Dis 2001;32:851–4.
15. Mayumi T, Ura H, Arata S, Kitamura N, Kiriyama I, Shibuya K, et
al. Evidence-based clinical practice guidelines for acute pancreati-
tis: proposals. J Hepatobiliary Pancreat Surg 2002;9:413–22.
16. Takada T, Hirata K, Mayumi T, Yoshida M, Sekimoto M, Hirota
M, et al. JPN Guidelines for the management of acute pancreati-
tis: the cutting edge. J Hepatobiliary Pancreat Surg 2006;13:2–6.
Discussion at the Tokyo International
Consensus Meeting
Tadahiro Takada (Japan): “Dr. Strasberg, please ex-
plain the difference between a ‘Guidelines’ and ‘Stand-
ards’ in your mind?”
Steven Strasberg (USA): “To me, ‘guidelines’ repre-
sent a suggested course of action based on available
evidence. They do not imply that other courses of action
are below an acceptable level of care. Practice ‘stand-
ards’ are different, in that they imply that actions other
than those listed as acceptable practice standards are
below the level of acceptable care. It is particularly true
that, in an area in which high levels of evidence are not
available, that guidelines are not construed to be stand-
ards. Reliance on expert opinion to form guidelines may
be useful, but even a consensus of experts may not be
correct. For this reason a statement of the following
type should be inserted in the introduction. ‘The prac-
tice guidelines promulgated in this work do not repre-
sent a standard of practice. They are a suggested plan
of care based on best available evidence and a consen-
sus of experts, but they do not exclude other approaches
as being within the standard of practice’.”
Table 3. Grading system for ranking recommendations in clinical guidelines14–16
Grade of recommendation
A Good evidence to support a recommendation for use
B Moderate evidence to support a recommendation for use
C Poor evidence to support a recommendation, or the effect may not exceed the adverse effects
and/or inconvenience (toxicity, interaction between drugs and cost)
D Moderate evidence to support a recommendation against use
E Good evidence to support a recommendation against use
8 T. Takada et al.: Background of Tokyo Guidelines
The Members of Organizing Committee and Contributors for
Tokyo Guidelines
Members of the Organizing Committee of Tokyo Guidelines for the Management of Acute Cholangitis
and Cholecystitis
T. Takada Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan
Y. Nimura Division of Surgical Oncology, Department of Surgery, Nagoya University, Graduate School of
Medicine, Nagoya, Japan
Y. Kawarada Mie University, Mie, Japan
K. Hirata First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo,
Japan
H. Yasuda Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan
Y. Yamashita Department of Surgery, Fukuoka University School of Medicine, Fukuoka, Japan
Y. Kimura First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo,
Japan
M. Sekimoto Department of Healthcare Economics and Quality Management, Kyoto University Graduate
School of Medicine, Kyoto, Japan
T. Tsuyuguchi Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba Univer-
sity, Chiba, Japan
M. Nagino Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of
Medicine, Nagoya, Japan
M. Hirota Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical
Sciences, Kumamoto, Japan
T. Mayumi Department of Emergency Medicine and Critical Care, Nagoya University Graduate School of
Medicine, Nagoya, Japan
F. Miura Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan
M. Yoshida Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan
Advisors and International Members of Tokyo Guidelines for the Management of Acute Cholangitis
and Cholecystitis
N. Abe Department of Surgery, Kyorin University School of Medicine, Tokyo, Japan
S. Arii Department of Hepato-Biliary-Pancreatic / General Surgery, Tokyo Medical and Dental
University, Tokyo, Japan
J. Belghiti Department of Digestive Surgery & Transplantation, Hospital Beaujon, Clichy, France
G. Belli Department of General and HPB Surgery, Loreto Nuovo Hospital, Naples, Italy
P.C. Bornman Division of General Surgery, University of Cape Town, Cape Town, South Africa
M.W. Büchler Department of General Surgery, University of Heidelberg, Germany
A.C.W. Chan Director Endoscopy Centre, Specialist in General Surgery, Minimally Invastive Surgery
Centre
M.F. Chen Chang Gung Memorial Hospital, Chang Gung Medical University, Taiwan
X.P. Chen Department of Surgery, Tongji Hunter College, Tongji Hospital Hepatic Surgery Centre,
China
E.D. Santibanes HPB and Liver Transplant Unit, Hospital Italiano de Buenos Aires, Argentina
C. Dervenis First Department of Surgery, Agia Olga Hospital, Greece
S. Dowaki Department of Digestive Surgery, Tokai University Tokyo Hospita, Kanagawa, Japan
S.T. Fan Department of Surgery, The University of Hong Kong Medicak Centre, Queen Mary Hospital,
Hong Kong
H. Fujii 1
st Department of Surgery, University of Yamanashi Faculty of Medicine, Yamanashi, Japan
T.R. Gadacz Gastrointestinal Surgery, Medical College of Georgia, USA
D.J. Gouma Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands
T. Takada et al.: Background of Tokyo Guidelines 9
S.C. Hilvano Department of Surgery, College of Medical & Philippine General Hospital, Philippines
S. Isaji Department of Hepato-Biliary-Pancreatic Surgery, Mie University Graduate School of Medi-
cine, Mie, Japan
M. Ito Department of Surgery, Fujita Health University, Nagoya, Japan
T. Kanematsu Second Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,
Nagasaki, Japan
N. Kano Special Adviser to the President, Chairman of Department of Surgery and Director of Endo-
scopic Surgical Center, Kameda Medical Center, Chiba, Japan
C.G. Ker Division of HPB Surgery, Yuan’s General Hospital, Taiwan
M.H. Kim Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medi-
cine, Korea
S.W. Kim Department of Surgery, Seoul National University College of Medicine, Korea
W. Kimura First Department of Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan
S. Kitano First Department of Surgery, Oita University Faculty of Medicine, Oita, Japan
E.C.S. Lai Pedder Medical Partners, Hong Kong
J.W.Y. Lau Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong
K.H. Liau Department of Surgery, Tan Tock Seng Hospital/Hepatobiliary Surgery, Singapore
S. Miyakawa Department of Surgery, Fujita Health University, Nagoya, Japan
K. Miyazaki Department of Surgery, Saga Medical School, Saga University Faculty of Medicine, Saga,
Japan
H. Nagai Department of Surgery, Jichi Medical School, Tokyo, Japan
T. Nakagohri Department of Surgery, National Cancer Center Hospital East, Chiba, Japan
H. Neuhaus Internal Medicine Evangelisches Krankenhaus Dusseldorf, Germany
T. Ohta Department of Digestive Surgery, Kanazawa University Hospital, Ishikawa, Japan
K. Okamoto First Department of Surgery, School of Medicine, University of Occupational and Environ-
mental Health, Fukuoka, Japan
R.T. Padbury Department of Surgery, The Flinders University of South Australia GPO, Australia)
B.B. Philippi Department of Surgery, University of Indonesia, Cipto Mangunkusumo National Hospital,
Jakarta, Indonesia
H.A. Pitt Department of Surgery, Indiana University School of Medicine, USA
M. Ryu Chiba Cancer Center, Chiba, Japan
V. Sachakul Department of Surgery, Phramongkutklao College of Medecine, Thailand
M. Shimazu Department of Surgery, Keio University School of Medicine, Tokyo, Japan
T. Shimizu Department of Surgery, Nagaoka Chuo General Hospital, Niigata, Japan
K. Shiratori Department of Digestive tract internal medicine, Tokyo Women’s Medical University, Tokyo,
Japan
H. Singh Department of HPB Surgery, Selayang Hospital, Malaysia
J.S. Solomkin Department of Surgery, University of Cincinnati College of Medicine Cincinnati, Ohio, USA
S.M. Strasberg Department of Surgery, Washington University in St Louis and Barnes-Jewish Hospital, USA
K. Suto Department of Surgery, Yamagata University Faculty of Medicine, Yamagata, Japan
A.N. Supe Department of Surgical Gastroenterology, Seth G S Medical College and K E M Hospital,
India
M. Tada Department of Digestive tract internal medicine, Graduate School of Medicine University of
Tokyo, Tokyo, Japan
S. Takao Research Center for life science resources, Kagoshima University Faculty of Medicine,
Kagoshima, Japan
H. Takikawa Teikyo University School of Medicine, Tokyo, Japan
M. Tanaka Department of Surgery and Oncology, Graduate School of Medical Sciences Kyushu University,
Fukuoka, Japan
S. Tashiro Shikoku Central Hospital, Ehime, Japan
S. Tazuma Department of Primary Care Medicine, Hiroshima University School of Medicine, Hiroshima,
Japan
M. Unno Department of Digestive Surgery, Tohoku University Graduate School of Medicine, Miyagi,
Japan
G. Wanatabe Department of Digestive Surgery, Toranomon Hospital Tokyo, Tokyo, Japan
10 T. Takada et al.: Background of Tokyo Guidelines
J.A. Windsor Department of General Surgery, Auckland Hospital, New Zealand
H. Yamaue Second Department of Surgery, Wakayama Medical University School of Medicine, Wakayama,
Japan
Working group of the Guidelines for the Management of Acute Cholangitis and Cholecystitis
M. Mayumi Department of Emergency Medicine and Critical Care, Nagoya University School of Medicine,
Nagoya, Japan
M. Yoshida Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan
T. Sakai Kyoto Katsura Hospital, General Internal Medicine, Kyoto, Japan
N. Abe Department of Surgery, Kyorin University School of Medicine, Tokyo, Japan
M. Ito Department of surgery, Fujita-Health University, Aichi, Japan
H. Ueno Department of Emergency and Critical Care Medicine, Graduate School of Medicine, Chiba
University, Chiba, Japan
M. Unno Department of Surgery, Tohoku University Graduate School of Medical Science, Sendai,
Japan
Y. Kimura First Department of Surgery, Sapporo Medical University School of Medicine, Sapporo,
Japan
M. Sekimoto Department of Healthcare Economics and Quality Management, Kyoto University Graduate
School of Medicine, Kyoto, Japan
S. Dowaki Department of Surgery, Tokai University School of Medicine, Kanagawa, Japan
N. Nago Japanese Association for Development of Community Medicine, Yokosuka Uwamachi
Hospital, Yokosuka, Japan
J. Hata Department of Laboratory Medicine, Kawasaki Medical School, Kurashiki, Japan
M. Hirota Department of Gastroenterological Surgery, Kumamoto University Graduate School of Medical
Sciences, Kumamoto, Japan
F. Miura Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan
Y. Ogura Department of Pediatric Surgery, Nagoya University School of Medicine, Nagoya, Japan
A. Tanaka Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan
T. Tsuyuguchi Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba
University, Chiba, Japan
M. Nagino Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of
Medicine, Nagoya, Japan
K. Suto Department of Gastroenterological and General Surgery, Course of Organ Functions and
Controls, Yamagata University School of Medicine, Yamagata, Japan
T. Ohta Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University,
Tokyo, Japan
I. Endo Department of Gastroenterological Surgery, Yokohama City University Graduate School of
Medicine, Yokohama, Japan
Y. Yamashita Department of Surgery, Fukuoka University Hospital, Fukuoka, Japan
S. Yokomuro Nippon Medical School, Graduate School of Medicine Surgery for Organ Function and Biologi-
cal Regulation, Tokyo, Japan
Members of the External Evaluation Committee
T. Fukui St. Luke’s International Hospital, Tokyo, Japan
Y. Imanaka Department of Healthcare Economics and Quality Management, Kyoto University Graduate
School of Medicine, Kyoto, Japan
Y. Sumiyama Third Department of Surgery, Toho University School of Medicine, Tokyo, Japan
T. Shimizu Department of Surgery, Nagaoka chuo General Hospital, Nagaoka, Japan
H. Saisho Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba Univer-
sity, Chiba, Japan
K. Okamoto First Department of Surgery, School of Medicine, University of Occupational and Environmen-
tal Health, Kitakyushu, Japan
