American Journal of Gastroenterology
C ?2004 by Am. Coll. of Gastroenterology
Published by Blackwell Publishing
Endoscopic Balloon Dilation of Ileal Pouch Strictures
Bo Shen, M.D., Victor W. Fazio, M.B., M.S., Feza H. Remzi, M.D., Conor P. Delaney, M.D., Ph.D.,
Jean-Paul Achkar, M.D., Anna Bennett, M.D., Farah Khandwala, M.S., Aaron Brzezinski, M.D.,
Jhony Doumit, M.D., Wendy Liu, M.D., Ph.D., and Bret A. Lashner, M.D., M.P.H.
Departments of Gastroenterology/Hepatology; Colorectal Surgery; Anatomic Pathology; Center for
Inflammatory Bowel Disease, The Cleveland Clinic Foundation, Cleveland, Ohio
BACKGROUND:Restorative proctocolectomy with ileal pouch-anal anastomosis is the surgical treatment of choice in
patients with ulcerative colitis. Strictures can occur at the inlet and outlet of the pouch. Endoscopic
balloon dilation has been successfully used in patients with Crohn’s strictures at the small intestine
and colon. There are no published trials on endoscopic balloon therapy of ileal pouch strictures.
AIM:To evaluate outpatient endoscopic balloon dilation of strictures in ileal pouches.
METHODS:Patients underwent nonfluoroscopy-guided, nonsedated, outpatient endoscopic dilations with an
8.6-mm upper endoscope and through-the-scope balloons (size: 11–18 mm). Pre- and
posttreatment Pouchitis Disease Activity Index symptom scores (range: 0–6), endoscopic stricture
scores based on resistance in passing the endoscope (range: 0–4), and Cleveland Global Quality of
Life were compared.
RESULTS:Nineteen patients with pouch strictures who had concurrent Crohn’s disease of the pouch (n = 11),
cuffitis (n = 5), and pouchitis (n = 3), including 14 inlet and 14 outlet strictures, were enrolled. The
mean number of strictures for each patient was 1.61 ± 0.78. All strictures were successfully dilated
with the through-the-scope balloon, with a mean of 1.74 ± 1.19 (range: 1–5) sessions for each
patient. Nine patients had a second endoscopy at 8 wk and five patients had a third pouch
endoscopy at 16 wk after the initial endoscopic dilation. Endoscopic stricture scores immediately
(0.30 ± 0.47), 8 wk (0.40 ± 0.51), and 16 wk (0.44 ± 0.76) after the dilation were significantly
improved compared to the predilation stricture scores (2.67 ± 0.78). The symptom scores and
quality-of-life (QOL) scores improved at week 8 and 16 following dilation, with a mean follow-up of
6.10 ± 5.83 months (2–25 months). No complications were experienced with the procedure. One
patient with CD who failed endoscopic and medical therapy underwent pouch resection.
CONCLUSION:In conjunction with medical therapy, outpatient endoscopic balloon dilation appears safe and
effective in treating pouch inlet and outlet strictures, by relieving symptoms, restoring pouch
patency, and improving QOL in the majority of patients.
(Am J Gastroenterol 2004;99:2340–2347)
Restorative proctocolectomy with ileal pouch-anal anasto-
mosis (IPAA) is the surgical treatment of choice for patients
with medically refractory ulcerative colitis (UC), UC with
dysplasia, or familial adenomatous polyposis (1, 2). Restora-
tive proctocolectomy with IPAA has improved health-related
quality-of-life (QOL) scores in UC patients who required
surgery (3–7). However, problems such as pouchitis, cuffitis
(inflammation of the rectal cuff or anal transitional zone),
or Crohn’s disease (CD) of the pouch, can develop after the
surgery. The IPAA complications can be classified as me-
chanical (such as strictures, fistula, leak, or afferent limb
functional (such as irritable pouch syndrome).
This work is supported in part by NIH 1 R03 DK067275 (to B.S.). This work was
partly presented at the Digestive Disease Week in New Orleans, LA, May 2004.
Two common locations are prone to develop strictures, the
at the junction of neo-terminal ileum and pouch. Other loca-
tions of strictures are at the mid-pouch, pouch-rectal anasto-
mosis, and distal small intestine. Causes of strictures include
of the pouch strictures, especially inlet stricture, can be chal-
lenging. There is limited data in the management of pouch
strictures. Endoscopic balloon dilations have been used for
patients with Crohn’s strictures at the ileocolonic or colo-
colonic anastomosis, colon, and small intestines (9–12). The
procedure appears safe and effective in avoiding or postpon-
ing surgery (9–12). Topical injection of a long-acting corti-
costeroid after endoscopic dilation of anastomotic strictures
may help to maintain luminal patency (10, 11). However, en-
doscopic balloon dilation has not been evaluated in pouch
strictures. The aim of this study was to assess feasibility,
Endoscopic Balloon Dilation of Ileal Pouch Strictures2341
safety, and efficacy of outpatient endoscopic balloon dilation
of strictures in IPAA.
The Cleveland Clinic Institutional Review Board approved
the study (IRB#6844). We enrolled 19 consecutive IPAA pa-
Bowel Disease. All the 19 patients had a preoperative diag-
nosis of UC with medically refractory disease or dysplasia.
To avoid selection bias, 19 consecutive patients with pouch
strictures referred to the primary investigator (B.S.) from
May 2002 to March 2004 were all included in the study. All
were balloon-dilated by the single investigator. Patients with
mechanical complications from the surgery such as pouch
leak, afferent limb syndrome, and abscess or sepsis were ex-
out concurrent inflammatory complications of IPAA were
Clinical Evaluation and Follow-up
Patients’ demographic, clinical, endoscopic, and histologic
data were collected. The Pouchitis Disease Activity Index
(PDAI) instrument (13) also was used to quantify symptoms,
endoscopic, and histologic inflammation. In addition to the
PDAI symptom scores (ranging from 0 to 6 points) bleed-
ing, fever, obstruction (persistent nausea, vomiting, bloat-
ing), stool consistency, food or stress-associated symptom
exacerbation, and bloating were evaluated. Use of concur-
rent medication was documented.
Endoscopic Evaluation and Dilation
Outpatient nonfluoroscopy-guided, nonsedated, outpatient
Figure 1. Through-the-scope balloon with a guidewire and pressure gauge (A). The balloon is passed through the operating channel of an
upper endoscope (B).
video upper endoscope (GIF-160, Olympus Optical Co.,
Ltd, Tokyo, Japan) and through-the-scope balloons (CRE
balloons, Boston Scientific Microvasive, Natick, MA) were
performed. The balloon size ranged from 11 to 18 mm
(Fig. 1). A pouch-anal anastomosis stricture was suspected
when the anal canal could not admit endoscopist’s little fin-
ger during digital examination and no digital dilation was at-
tempted. Segmental evaluation of the prepouch neo-terminal
ileum, pouch, and cuff was conducted with minimal air in-
sufflation. There was an open space between the distal tip of
endoscope and the proximal end of balloon, which allowed
anal canal and anal sphincter to be undisturbed during dila-
tion, which minimized patients’ discomfort (Fig. 2).
The degree of stricture was quantified by the endoscopist
based on the degree of resistance to the passage of the endo-
resistance; 3 = severe resistance; and 4 = pinhole and not
traversable). The sizes of the balloons were chosen based on
the degree of strictures. For high-grade inlet and outlet stric-
tures not traversable by the endoscope, CRE balloon with a
guidewire was used after retrograde pouchography was per-
formed, excluding the strictures or fistulas at the proximal
neo-terminal ileum. Sequential dilations with the same bal-
loon up to three sizes were performed. Passage through the
passage without resistance was interpreted as a sign of tech-
nical success. At the site of strictures, 4-quadrant endoscopic
injection of triamcinolone (5 ml of 40 mg/ml diluted to 5
ml with normal saline, 1 ml aliquots in each quadrant) was
following the balloon dilation (Fig. 3). Patients were closely
during and after the procedure.
Segmental biopsies from the prepouch neo-terminal ileum,
pouch, and cuff were taken and labeled separately. Mucosal
2342Shen et al.
Figure 2. Inlet and outlet strictures (A) and balloon dilation treatment (B and C). Notice an open space between the distal end of endoscope
and the proximal end of balloon during the dilation of outlet stricture (C), which allows avoidance of irritation of anal sphincters.
patient with Crohn’s disease.
Endoscopic balloon dilation with topical corticosteroid injection of a high-grade (stricture score = 4) pouch inlet stricture in a
Endoscopic Balloon Dilation of Ileal Pouch Strictures2343
biopsies were taken from the areas with maximal inflamma-
tion in the neo-terminal ileum, pouch, and cuff, or from the
posterior wall of the pouch if the pouch had a normal en-
doscopic appearance. Based on the PDAI histology scores
(ranging from 0 to 6 points), the gastrointestinal patholo-
gist, who was blinded to demographic, clinical, endoscopic,
and histologic data, assessed and graded inflammation of
the biopsy specimens from the neo-terminal ileum, pouch,
and cuff. Additional features of mucosal histopathology
were documented, including dysplasia, granuloma, pyloric
gland metaplasia, and cytomegalovirus infection. During the
follow-up endoscopy, mucosal biopsies were not taken.
Concurrent inflammatory conditions (CD of the pouch,
pouchitis, or cuffitis) were diagnosed based on combined as-
sessment of clinical, endoscopic, and histologic data. CD of
the pouch was diagnosed based on presence of nonsurgery-
related perianal fistula or inflammation or ulcerations at the
prepouch neo-terminal ileum or small bowel in the absence
of NSAID use, or granulomas on histology. The 18-point
PDAI was used for the diagnosis of pouchitis. Pouchitis was
PDAI ≥ 7. Cuffitis was defined as inflammation of the rec-
tal cuff or anal transitional zone on endoscopy and histology
without or with minimal inflammation of the pouch.
Outcome was measured by assessing scores of symptoms,
QOL, and stricture before and after dilatation and by assess-
ing need for surgery. Patients were scheduled for follow-up
clinical and endoscopic evaluation at week 8 and 16 after the
initial treatment to assess patency of dilated strictures as well
as mucosal inflammation. If strictures persisted or recurred,
additional endoscopic balloon dilations were performed. We
compared the pre- and posttreatment PDAI symptom scores
(range: 0–6), endoscopic stricture scores, and the Cleveland
Global Quality of Life (CGQL, range: 0–1, with 1 being the
best QOL). The 3-item CGQL was specifically designed for
the IPAA patients (3). All questionnaires were filled by the
and endoscopic evaluations. For patients who failed to come
for a follow-up visit, telephone contact was conducted for
the documentation of questionnaires of the PDAI symptom
scores and CGQL at week 16.
In patients with prior diagnoses of CD of the pouch, pou-
chitis, or cuffitis who had been on immunomodulators, in-
fliximab, coticosteroids, mesalamines, or antibiotics, their
out the 16-wk follow-up. In patients with the newly detected
pouch strictures who had concurrent CD of the pouch, pou-
chitis, or cuffitis at entry, the following medical regimens
were given: (1) budesonide 9 mg/day × 8 wk and long-
term 6-mercaptopurine 1.5 mg/kg/day for CD of the pouch,
(2) ciprofloxacin 500 mg b.i.d. PO × 8 wk for pouchitis, and
Student’s t and χ2tests were used to compare the pre- and
as statistically significant.
The 19 patients consisted of a group of mixed patients with
CD of the pouch, pouchitis, and cuffitis. Eleven CD of the
a preoperative diagnosis of UC (Tables 1–3). Fistulas were
seen only in patients with CD of the pouch (Table 2). One
patient had granulomas and two patients had pyloric gland
metaplasia on pouch biopsy specimens.
In addition to the symptoms listed in the PDAI instru-
tive symptoms, extraintestinal manifestations, bleeding, and
weight loss (Table 2).
The length of strictures was measured with endoscopy.
None of the strictures was longer than 1.0 cm. All strictures
had superficial ulceration on the overlying mucosa. The in-
let strictures occurred only in patients with CD. Two patients
with CD had a stricture only at the outlet. Strictures that oc-
curred in patients with pouchitis and cuffitis all were located
in the pouch outlet (pouch-anal anastomosis) (Table 3). The
technical success rate for balloon dilation was high (100%).
All inlet and outlet stricture become traversable to the GIF
Table 1. Demographic Data of the 19 Patients with Pouch Strictures
Age, yr, ±SD
Male gender, n (%)
Duration of UC, yr, ±SD
Duration of IPAA, yr, ±SD
Fulminant colitis, n (%)
Indications for colectomy, n (%)
UC with dysplasia or cancer
Type of pouch, n (%)
Ileal pouch-rectal anastomosis
Pancolitis, n (%)
Stages of IPAA, n (%)
NSAIDS more often than monthly, n (%)
Current smoking, n (%)
Family history of IBD in first-degree
relatives, n (%)
Mean number of strictures, ±SD
35.6 ± 11.6
14.4 ± 6.1
7.4 ± 5.4
1.74 ± 1.19
2344Shen et al.
Table 2. Clinical Presentations in the 19 Patients with Pouch
Nausea or vomiting
Daily use of antidiarrheal agents
Primary sclerosing cholangitis
Iritis or uveitis
scope with no or minimal resistance after balloon dilation,
feasible (Fig. 3).
The mean number of dilation sessions was 1.74 ± 1.19
(range: 1–5). Balloon sizes ranged from 11 to 18 mm. The
ultimate goal was to keep luminal patency ≥15 mm. For in-
following the dilation. The mean duration of follow-up af-
ter dilation was 6.10 ± 5.83 months (range: 2–25 months).
Endoscopic dilation together with concurrent medical ther-
apy lead to the improved PDAI symptom scores, stricture
scores, and the CGQL scores (Figs. 4–6). Nine patients and
five patients had a follow-up pouch endoscopy at week 8 and
16, respectively, and the stricture scores were available for
calculation. The PDAI symptom scores and CGQL scores in
able for calculation. The rest of the patients either were lost
to follow-up despite multiple attempts at telephone contact
or had initial stricture dilation <8 wk (Table 4).
The mean PDAI symptom scores at week 8 and 16 were
1.89 ± 1.69 and 1.27 ± 0.79, respectively, which were sig-
nificantly lower than the predilation baseline of 3.32 ± 1.25
(p < 0.03) (Fig. 4). The mean stricture scores immediately
0.51, and 0.44 ± 0.78, respectively, which were significantly
improved from the predilation baseline of 2.67 ± 0.78 (p <
0.001) (Fig. 5). The dilation with concurrent medicines lead
to the improvement of QOL, as evidenced by the increase in
Crohn’s disease of the pouch
and 8 and 16 wk after endoscopic balloon dilation. The horizontal
bars indicate statistical means.
Pouchitis Disease Activity Index symptom scores before
at week 8 and 0.71 ± 0.11 at week 16 (p < 0.007) (Fig. 6).
inal pain, bleeding, or perforation were experienced by any
patients. One CD patient with both inlet (stricture score = 3)
the pouch and neo-terminal ileum was scheduled for pouch
resection and ileostomy. The inlet and outlet strictures ini-
tially responded to the balloon dilations, with improvement
of symptoms and QOL scores. However, the inlet stricture
(stricture score = 2) and obstructive symptoms recurred, de-
spite repeat dilations and concurrent use of methotrexate and
Medical therapy was instituted for patients with CD of the
pouch, pouchitis, and cuffitis, respectively. In the 11 patients
tion. The horizontal bars indicate statistical means. The mean num-
ber of dilation sessions was 1.74 ± 1.19 (range: 1–5).
Endoscopic Balloon Dilation of Ileal Pouch Strictures2345
after endoscopic balloon dilation. The horizontal bar indicates sta-
The Cleveland Global Quality of Life scores before and
with CD of the pouch, the following medicines were given:
scheduled infliximab infusion (2 patients), oral budesonide
(3 patients), oral mesalamine (3 patients), 6-mercaptopurine
(3 patients), methotrexate (1 patient), ciprofloxacin (3 pa-
tients), and metronidazole (1 patient). Some of patients with
CD of the pouch received a combination of medical ther-
apy. All five patients with cuffitis were treated with topi-
cal mesalamine suppositories (Canasa®500 mg b.i.d.) and
three patients with pouchitis were treated with ciprofloxacin,
500 mg b.i.d. PO. During the follow-up period, all patients
continued their initial regimen with no alterations in the
dilation along with medical therapy. To our knowledge, this
balloon treatment of the pouch inlet and outlet strictures. All
19 patients were symptomatic and had concurrent CD of the
pouch, cuffitis, or pouchitis. Pouch inlet strictures were ex-
clusively seen in patients with CD of the pouch. Outpatient
endoscopic balloon dilation appears well tolerated, safe, and
feasible. In conjunction with medical therapy, endoscopic di-
lation appears to be effective in maintaining the pouch inlet
Table 4. Immediate Effect of Endoscopic Balloon Dilation of Inlet
and Outlet Strictures of IPAA
Strictures Scores (±SD) Scores (±SD) Value
143.14 ± 0.77
152.21 ± 0.42
0.57 ± 0.51
and outlet patency, relieving symptoms, and improving pa-
tients’ QOL scores in the majority of patients.
ileum. This is not a common location for ischemic or anas-
tomotic strictures. Patients with pouch inlet strictures often
had concurrent inflammation of the neo-terminal ileum and
pouch. In this cohort, patients with inlet strictures all had
CD, of whom some had additional strictures at the distal
neo-terminal ileum above the junction. The inlet strictures
all were short (<1.0 cm), which make endoscopic dilation
feasible and safe.
Pouch-anal anastomotic strictures (outlet strictures) are
tional outcome (15, 19). In one study of 102 patients with
IPAA, the prevalence of outlet strictures was as high as 38%
(8). The risk factors that may be associated with pouch-
small diameter staple gun, use of a quadruplicated reservoir,
use of a defunctioning ileostomy, anastomotic dehiscence,
pelvic sepsis, “W”-shaped pouch (8), excessive operative
blood loss, and overweight male gender (17). Cuffitis may
be an additional contributing factor for the development of
outlet strictures. Under this circumstance, concurrent use of
topical antiinflammatory agents, such as mesalamine or cor-
ticosteroids, in addition to endoscopic balloon dilations, is
Dilation of outlet strictures using bougies under the gen-
eral anesthesia (8, 14) or self-dilation at home (18) is part
of a salvage strategy to manage the IPAA complications be-
fore pouch resection. Prudhomme et al. (18) further classi-
fied the outlet strictures into fibrotic and nonfibrotic based
on the presence of palpable fibrosis on digital examination.
It appears that nonfibrotic strictures were more responsive
to dilation therapy than the fibrotic strictures (18). Dila-
tion of outlet stricture or pouch-anal anastomotic stricture
can be uncomfortable. However, in the authors’ experience,
this is much more often experienced by patients with long
(≥1.0 cm) or high-grade outlet stricture who underwent
results from pressure or irritation of the anal canal or anal
sphincter. In these conditions, dilation with intravenous se-
dation or under general anesthesia would be recommended.
In this series, all inlet or outlet strictures were <1 cm in
length. We achieved the goal for both diagnostic evaluation
and balloon dilation during the same session of endoscopy.
Advantages of endoscopic balloon dilation over bougie dila-
tion are (1) dilation is performed under a direct endoscopic
doscope and the proximal end of balloon, which allows anal
canal and anal sphincter to be undisturbed during dilation,
minimizing patients’ discomfort.
Do all pouch strictures require treatment? Analogous
to this question is that ileocolonic strictures in some pa-
tients with CD after ileocolectomy may not progress for
years (20). It is still controversial regarding whether to treat
2346Shen et al.
asymptomatic patients with ileocolonic stricture and a simi-
lar question would be raised in the inlet and outlet stricture
that the symptomatic patients with pouch strictures should
be treated, if a treatment modality is easy, safe, and effective,
verse consequences. The alternatives for the balloon dilation
would be medical therapy alone, pouch resection or recon-
struction, or proximal diverting stoma (8, 18, 21), or surgical
All 19 patients in this series had concurrent inflamma-
tory complications of IPAA, i.e., CD of the pouch, pouchitis,
and cuffitis. Although we do not know to what degree these
inflammatory conditions contributed to the development of
pouch strictures, we believe that it is necessary to medically
treat the inflammation. The improvement in patients’ symp-
toms, stricture scores, and QOL after endoscopic dilation
might also attribute to the concomitant use of antiinflam-
matory agents or immunomodulators. For the patients with
CD of the pouch in this study, a spectrum of medicines were
ticosteroids, and infliximab. Antibiotics were used for pou-
chitis. Topical mesalamine suppositories were used in pa-
tients in cuffitis. Our recent study showed that the use of
doscopic, and histologic scores in patients with cuffitis (23).
This case series consisted of a mixed group of patients with
different underlying diseases, i.e., CD of the pouch, cuffitis,
and pouchitis. This leads to the concomitant use of a variety
of medicines, which could be the confounding factors for the
assessment of sole effect of endoscopic dilation on pouch
strictures. Nonetheless, combined endoscopic and medical
stricture) and inflammatory (i.e., CD, pouchitis, or cuffitis).
The major limitation of the study is the absence of a control
anastomotic strictures without the concurrent inflammatory
with bougie dilation without endoscopy in an outpatient
The endoscopic balloon dilation has been investigated in
patients with Crohn’s strictures of the small bowel, colon,
or anastomosis. The majority of the studies were retrospec-
tive and colonoscope was used. Measurement of outcome
included symptom relief (9–11, 24, 25) and avoidance of
surgery (9, 24). There is little literature on pouch stricture
endoscope and a through-the-scope balloon to dilate pouch
stricture. An upper endoscope has advantage over adult or
pediatric colonoscope or flexible sigmoidoscope, for being
small-caliber and more flexible. We expanded the variables
of outcome measurement used in the literature by assessing
patients’ symptom scores, QOL scores, stricture scores, and
current medical therapy. We assumed that subjective symp-
tom score and QOL score were more likely affected by con-
current medical therapy than stricture score measured during
endoscopy. We believed that stricture scores before and after
endoscopic treatment more likely reflected the effect from
the balloon dilation than that from the concurrent medical
therapy. To our knowledge, there are no validated stricture
scores in IBD available. The stricture scores designed and
used in this study need to be validated in future multicenter,
randomized trials. No doubt there was intraobserver and in-
terobserver variation in measuring the degree of strictures.
We would speculate that interobserver variability would be
greater than intraobserver variability. To maximize consis-
tency in assessing degree of strictures, a single endoscopist
performed all pouch endoscopy and dilations.
patients from out of state at a great geographic distance from
authors’ institution; (2) some patients might feel better after
To make sure that noncompliance in some patients was not
due to the deterioration of symptoms or disease conditions,
follow-up telephone contact was attempted. Because of its
small sample size, the data were only analyzed per protocol.
In summary, endoscopic balloon dilation of pouch inlet
and outlet strictures appears feasible and safe. Endoscopic
dilation, in combination with medical therapy, may prolong
long-term follow-up is warranted.
Reprint requests and correspondence: Bo Shen, M.D., Depart-
ment of Gastroenterology/Hepatology—Desk A30, The Cleveland
Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195.
Received June 28, 2004; accepted July 1, 2004.
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