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İzmir Kâtip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi 2022;7(2): 321-329 İzmir Kâtip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi 2022; 7(2): 321-329
Ulger et al., Intragastric balloon, transpyloric shuttle and obesity
İzmir Kâtip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi 2022; 7(2): 321-329
İKÇÜSBFD
Geliş tarihi/Received: 21.10.2021
Kabul tarihi/Accepted: 29.04.2022
Sorumlu Yazar/Corresponding Author:
Taha Gökmen ÜLGER, Dr. Dyt.
Bolu Abant İzzet Baysal Üniversitesi, Sağlık
Bilimleri Fakültesi, Beslenme ve Diyetetik Bölümü,
Bolu, Türkiye.
E-posta: tahagokmenulger@ibu.edu.tr
ORCID: 0000-0002-7751-9789
Muhittin TAYFUR, Prof. Dr.
ORCID: 0000-0003-3645-5579
Funda Pınar ÇAKIROĞLU, Prof. Dr.
ORCID: 0000-0003-2324-6874
Çiğdem ÖZCAN, Dr. Dyt.
ORCID: 0000-0001-7750-4520
SİSTEMATİK DERLEME / SYSTEMATIC REVIEW
Abstract
Endoscopic bariatric procedures in the treatment of obesity have become widespread
in recent years. In this systematic review, it was aimed to assess the role of intragastric
balloons and transpyloric shuttle in the treatment of obesity. A comprehensive
search was conducted using the search terms “Intragastric Balloon” and “TransPyloric
Shuttle” in PubMed, Cochrane Library and Web of Science databases from 1st of
December to 25th of December in 2020. Twenty-seven clinical studies (24 studies on
intragastric balloons and 3 studies on transpyloric shuttle) were assessed. It is clear
that both methods have signicant positive eects on obesity-related comorbidities
and weight loss. These techniques also have potential to reduce comedications in
patients with type 2 diabetes mellitus and obesity. The most important dierences
between intragastric balloons and transpyloric shuttle are in the severity and
frequency of the complications they cause. While the most common complications
related to intragastric balloons are vomiting, nausea, bloating, and abdominal pain,
the most common complications due to transpyloric shuttle are gastroduodenal
ulcers, gastroesophageal reux disease, and sore throat. In addition, one of the
most important nding is that the type and structure of the balloon, as well as the
application period and position of the balloon in the stomach, may cause changes in
the adverse and practical eects of intragastric balloons. As a conclusion, intragastric
balloon application is a relatively eective short term treatment and relatively safe
endoscopic technique used in patients with obesity to improve comorbidities
accompanying obesity, but with risks of adverse events. On the other hand, the safety
prole of the transpyloric shuttle still needs to be improved.
Anahtar Kelimeler: Gastric balloon, obesity management, endoscopic
gastrointestinal surgery.
Öz
Endoskopik bariatrik prosedürlerin obezite tedavisinde kullanımı son yıllarda
yaygınlaşmaya başlamıştır. Bu sistematik derlemede, obezite tedavisinde
intragastrik balon ve transpilorik shuttle uygulamalarının rolünün değerlendirilmesi
amaçlanmıştır. 1 Aralık 2020 – 25 Aralık 2020 tarihleri arasında PubMed, Cochrane
Library ve Web of Science veri tabanlarında “Intragastric Balloon” ve “TransPyloric
Shuttle” arama terimleri kullanılarak kapsamlı bir arama yapılmıştır. Toplam yirmi yedi
klinik çalışma (intragastrik balonlarla ilgili 24 ve transpilorik shuttle ile ilgili 3 çalışma)
değerlendirilmiştir. Her iki yöntemin de ağırlık kaybı ve obeziteye bağlı komorbiditeler
üzerine önemli olumlu etkilerinin olduğu açıktır. Bu tekniklerin ayrıca tip 2 diyabet
ve obezitesi olan hastalarda ilaç kullanımını azaltma potansiyeli de bulunmaktadır.
İntragastrik balon ve transpilorik shuttle uygulamaları arasındaki en önemli fark,
neden oldukları komplikasyonların sıklığı ve şiddetidir. İntragastrik balonlar ile
ilişkili en sık görülen komplikasyonlar bulantı, kusma, karın ağrısı ve şişkinlik iken,
transpilorik shuttle ile ilişkili en sık görülen komplikasyonlar gastroduodenal ülserler,
gastroözofageal reü hastalığı ve boğaz ağrısıdır. Tüm bunlara ek olarak elde edilen
en önemli bulgulardan birisi de balonların tipinin ve yapısının yanı sıra, balonun
uygulama süresi ve midedeki pozisyonunun da intragastrik balonların olumsuz
ve pratik etkilerinde değişikliklere neden olabileceği sonucudur. Sonuç olarak,
intragastrik balon uygulaması, obeziteye eşlik eden komorbiditeleri iyileştirmek için
obez hastalarda kullanılan, ancak yan etki riskleri olan ve nispeten kısa süreli etkili bir
endoskopik tekniktir. Diğer yandan, transpilorik shuttle tekniğinin güvenlik prolinin
iyileştirilmesi gerekmektedir.
Keywords: Gastrik balon, obezite yönetimi, endoskopik gastrointestinal cerrahi.
A Systematic Review on Intragastric Balloons and TransPyloric
Shuttle in Obesity Treatment
Obezite Tedavisinde İntragastrik Balonlar ve TransPyloric Shuttle
Üzerine Sistematik Bir İnceleme
Taha Gökmen ÜLGER1 , Muhittin TAYFUR1 , Funda Pınar ÇAKIROĞLU2 , Çiğdem ÖZCAN3
1 Bolu Abant İzzet Baysal Üniversitesi
2 Ankara Üniversitesi
3 Hacettepe Üniversitesi
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Ulger et al., Intragastric balloon, transpyloric shuttle and obesity
1. Introduction
Obesity is characterized by an excessive accumulation of
body fat and dened as a multi-factorial, relapsing, chronic,
neurobehavioral disease. Obesity has reached epidemic
proportions in the world and this complex disease is
interconnected with impaired quality of life, a multitude
of adverse health outcomes, and reduced life expectancy.
However, obesity, which has a high incidence not only in
adults but also in adolescents and children, is a preventable
health problem. Treatment modalities for obesity include
therapeutic lifestyle modications (diet, physical activity
etc.), pharmacotherapy, and bariatric surgery (1). Non-
surgical methods, such as dietary interventions and
lifestyle changes, may be insucient to provide permanent
and eective weight loss in some cases, and therefore,
surgical interventions may become necessary in those
circumstances (2).
A number of endoscopic techniques in obesity surgery have
been used in recent years, and the developments in this area
are closely followed by both physicians and patients with
obesity. Endoscopic techniques include space-occupying
techniques (transpyloric shuttle and intragastric balloons),
gastric plication and suturing techniques (endoscopic
sleeve or vertical gastroplasty, transoral gastroplasty,
primary obesity surgery endoluminal, and transoral
endoscopic restrictive implant system), gastrointesinal
bypass sleeves (duodenal jejunal bypass liner), intragastic
Botulinum Toxin A injection and aspiration therapy. Among
these methods, transpyloric shuttle (TPS) and intragastric
balloons (IGB) have been used frequently and are touted
as eective in the obesity treatment. In addition, these
methods are also used as bridging interventions before
laparoscopic bariatric surgery to reduce complication
risk. It is obvious that such endoscopic procedures will
be used more frequently in the future. In order for these
techniques to become more eective and safer in the
future, it is important to determine the eectiveness of,
and the complications that arise from, these procedures.
This paper reviews the eect of IGBs and TPS on weight loss
and obesity related parameters. In addition, adverse events
occurred due to the methods were also investigated.
2. Materials and Methods
2.1. Dening the Search Questions
The research questions reecting the purpose of this
systematic review are as follows;
•What are the eects of IGB and TPS applications on
weight loss in people with obesity?
•What are the complications caused by IGB and TPS
applications?
•What are the eects of IGB and TPS applications on
obesity-related complications?
•What are the roles of extra applications (diet, physical
activity, etc.) in addition to IGB and TPS in terms of the
eectiveness of IGB and TPS?
2.2. Data Sources and Searches
A deep search was performed to identify available clinical
studies evaluating the outcomes of IGBs and TPS in the
treatment of obesity by adhering to PRISMA statements
(Figure 1). Three databases including PubMed, Cochrane
Library, and Web of Science were searched from 1st of
December to 25th December in 2020 without language or
study design restriction. A systematic search was carried
out using the search terms as “Intragastric Balloon” and
‘‘TransPyloric Shuttle’’ by the authors. Additional eligible
researches were also tried to identify by manual search and
reviewing the reference list of included studies.
2.2. Eligibility Criteria
Clinical trials and observational prospective cohort studies
that were published and peer reviewed were included.
Editorials, reviews, retrospective studies, conference
abstracts, studies using nonhuman subjects, and case
reports were excluded as were articles without English
translation or full text availability. Studies on IGBs were
also excluded for the following reasons: [1] if there were
subjects under the age of 18 years; [2] if a study was
designed to evaluate endoscopic intervention’s ecacy for
a specic disease (non-alcoholic fatty liver disease, renal
diseases etc.) other than obesity, type 2 diabetes mellitus
(T2DM) or metabolic syndrome; [3] if a study’s outcomes
were not reported as total weight loss, absolute weight
loss, or excess weight loss; [4] if a study was designed
primarily to evaluate the eectiveness of medication,
aftercare programs, or a special diet application (ketogenic
diet, low carbohydrate diet, etc.) rather than endoscopic
intervention; [5] if the number of patients who were
undergone an endoscopic intervention was 20 or less at
the beginning or at the end of the study. The above criteria
have been considered in studies on IGB and were ignored
in the inclusion and exclusion of studies on TPS. In addition,
only studies published from 2015 onwards on IGBs were
included, while there was no restriction in terms of years in
the including of studies on the TPS technique.
2.3. Data Extraction and Outcomes
Twenty-four clinical studies on IGBs and 3 studies on TPS
were examined. Data for study characteristics, weight
loss outcomes at follow-up, procedure technique, patient
baseline characteristics, adverse/side events, and changes
in any obesity-related parameters were collected for each
study and organized in the tables.
3. Results and Discussion
3.1. General Characteristics of Intragastric Balloons
One of the methods considered as an alternative to
laparoscopic bariatric techniques in obesity treatment is IGB
application, and it is one of the most widely used endoscopic
techniques today. The IGB placement, which was rst used
in 1980s (3), is based on the endoscopic placement of a
balloon lled with liquid or gas into the stomach while
the patient is under sedation or general anesthesia. Today,
there are seven dierent types of intragastric balloons in
the world market, two of them (Orbera and Obalon) have
been approved by the Food and Drug Administration
(FDA) and two (Elipse and Spatz) are awaiting approval. Of
these FDA-approved balloons, Orbera is a single balloon
lled with saline, while Obalon is lled with nitrogen gas. In
addition, Obalon is a 3-balloon treatment in which a patient
swallows a balloon every 4 weeks (for a total of 12 weeks).
ReShape balloon which was a double balloon technique
connected in the middle by a tube has been taken o
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Ulger et al., Intragastric balloon, transpyloric shuttle and obesity
the market although it was previously approved by the
FDA. On the other hand, nitrogen-lled balloons require
endoscopy for removal only, while saline-lled balloons
require endoscopy for both implantation and removal.
In addition, all balloons stay in the stomach for up to 24
weeks/6 months (4).
Aplication of IGBs can modify the distribution of food
in the stomach, leading to distention of the antrum and
potentially invoking exaggerated fundic relaxation (5). The
positive eects of IGB application on the gastric emptying
rate (6) and the neurohormonal components that play a
role in hunger and satiety provide targeted weight loss.
However, there may be diversities in practical eects
depending on the dierences in the type and structure of
the balloons. For example, it is noted that gas lled IGBs
do not delay gastric emptying, unlike uid-lled IGBs
(7). In addition to the structural features of the balloon,
dierences in patient characteristics, position of the
balloon in the stomach, and application period may also
cause changes in the adverse and practical eects of IGBs.
It is stated that, displacement of the IGB from fundus to
antrum results in enhanced weight loss (8).
3.2. Eects of IGBs on Obesity Related Comorbidities and
Weight Loss
According to the clinical studies in the literature
evaluating the eectiveness of IGBs on obesity (Table
1), it is obvious that the method has signicant positive
eects on obesity-related comorbidities and weight loss.
Figure 1. PRISMA Flow Diagram Detailing the Process of Study Selection
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Ulger et al., Intragastric balloon, transpyloric shuttle and obesity
Application of intragastric balloon provides signicant
improvements in cholesterol, triglyceride, fasting
glucose, C-reactive protein, blood pressure, and HbA1c
levels and signicant reductions in the incidence of
T2DM, non-alcoholic fatty liver, metabolic syndrome,
hyperuricemia, osteoarthropathy, hypertriglyceridemia,
and hypercholesterolemia (Table 1). Intragastric balloons
can also be applied in adolescents with obesity and
give positive results in impaired blood pressure, insulin
resistance, and liver functions due to obesity. In addition
to these metabolic benets, IGB application also leads to
positive changes in sleep apnea and skeletal health (9,10)
3.3. IGBs and Neurohormonal Changes
Neurohormonal changes (ghrelin, leptin, cholecystokinin,
glucagon-like peptide-1 and pancreatic polypeptide)
caused by IGB treatment are not yet fully understood.
In the study conducted by Mathus-Vliegen and
Eichenberger (11), it was stated that IGB application had
no signicant eect on fasting and meal-suppressed
ghrelin concentrations, while Mion et al. (12) stated that
ghrelin level decreased with IGB application. Konopko-
Zubrzycka et al. (13) and Fuller et al. (14) stated that there
was an increase in ghrelin levels with the insertion of IGB,
but, a few months after the removal of the IGB, ghrelin
levels returned to their baseline values. The main reason
for dierent outcomes regarding neurohormonal changes
with IGB application may be due to the heterogeneity of
the methodology of IGB application in clinical studies.
Generally, the application period varies between 3-6
months, while the body mass index (BMI) values of the
individuals treated with IGB can vary between 27-60 kg/
m2. In other words, dierences in both the application
technique and the patient prole may result in dierent
outcomes.
3.4. Advantages/Disadvantages of IGBs and
Complications Related to IGBs
Advantages of intragastric balloon application include,
increasing the feeling of satiety by aecting the gastric
stretch receptors, and delaying the rate of gastric
emptying without altering stomach or intestinal anatomy.
Although the risk of severe adverse events caused by
IGB treatment is low, complications, such as esophageal
or gastric perforations, rupture/deation/displacement
of the balloon, acute pancreatitis, abdominal pain, and
gastric ulcer, may occur. In addition, chronic nausea,
vomiting, abdominal pain, and stomach cramps observed
in IGB implanted patients may cause the balloon to
be removed earlier than the prescribed time (6-15%
of the patients cannot tolerate balloon). On the other
hand, 33 deaths related to IGB treatment (ORBERA ve
ReShape) were reported from 2006 to 2018 (15), while
the treatment-related mortality rate was stated as 0.05%
(16). Despite the complication risks reported in the
literature, many reviews and meta-analyses have stated
that IGB treatment is a safe and eective technique in the
treatment of obesity (9,17,18). The lower complication
risk of the treatment than laparoscopic bariatric surgical
techniques and its provision of eective weight loss
facilitate patients’ compliance with the method. In this
way, IGB treatment stands out as an eective method in
the obesity treatment. In addition, the fact that it can be
applied to individuals with lower BMI values makes the
IGB method frequently used.
Table 1. Summary of Reported Outcome Data Following Intragastric Balloon Treatment (Results of Recent Studies Published Between the
years of 2015-2020).
Ref.
IGB Group
(I) n
(II) Initial BKI (kg/m2)
(III) Extra application
(IV) Treatment period
(V) Device
Control Group
(I) n
(II) Initial BKI (kg/m2)
(III) Extra application
Main outcomes Adverse events (n / %)
Con et al.
(22)
(I) 55, (II) 53.9, (III) NA, (IV) 6
months, (V) BioEnterics or
Heliosphere
(I) 60
(II) 54.7
(III) SMC, LCD
WL was signicantly greater in the IGB group than
in the SMC group. In addition, WL was similar in
both types of IGB. On the other hand, WL occurred
during the rst three month period, and the BW
then remained stable during the last three month
period.
BioEnterics group; esophageal tear (1),
hemorrhage (1). Heliosphere group;
unsuccessful balloon removal (surgical
gastrotomy was required).
Early removal of the IGB (5).
Mitura and
Garnysz,
(23)
(I) 57, (II) 37.2, (III) LCD+PA,
(IV)6 months, (V ) Orbera
(I) -
(II) -
(III) -
Upon balloon removal 6 months later, the
reduction in mean BW, BMI and EBW was 15.9 kg,
5.8 kg/m2 and 41%, respectively. In addition, the
reduction of > 10% WL, was achieved in all patients.
Vomiting (33), heartburn (27), abdominal
pain (13) and other complications (11).
Ponce et al.
(24)
(I) 187, (II) 35.4, (III) Diet
and exercise, (IV) 6
months, (V) ReShape
(I) 139
(II) 35.4
(III) Diet and exercise
The reduction in BW, BMI and EBW was 7.6%, 2.7
kg/m2 and 27.9% in IGB group, respectively. In
addition, the mean WL in the IGB group was more
than twice that of the control group.
Early deation (6%), early retrieval for
nonulcer intolerance (9%) and gastric ulcers
(NA).
Lopez-
Nava et al.
(25)
(I) 60,(II) 38.8, (III) LCD+PA,
(IV) 6 months, (V ) ReShape
(I) -
(II) -
(III) -
The reduction in mean BW, BMI and EBW was
15.4%, 6.1 kg/m2 and 47.1%, respectively. In
addition, most patients with morbid obesity (71.4
%) decreased their BMI below 40 kg/m2.
Early deation (1), gastric perforation (1)
and gastric ulcers or erosions (14).
Early removal of the IGB (1).
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Ulger et al., Intragastric balloon, transpyloric shuttle and obesity
Table 1. Summary of Reported Outcome Data Following Intragastric Balloon Treatment (Results of Recent Studies Published Between the
years of 2015-2020) (continued)
Palmisano
et al. (26)
(I) 81, (II) 39.6, (III) LCD
(800-1000 kcal/day), (IV)
6 months, (V) Heliosphere
and BioEnterics
(I) -
(II) -
(III) -
A signicant reduction in BW was observed at
device removal and 1 year thereafter. But most
of the patients (63%) were not satised with the
procedure, refused to perform it again, and did not
deem useful to change their diet.
NA
Mariani et
al. (27) (I) 32, (II) 41.8, (III) NA, (IV)
6 months, (V) BioEnterics
(I) 10
(II) 38.9
(III) LCD
A signicant reduction in BW, BMI, EBW and total
fat mass was observed, together with a signicant
increase in sirtuins level (main regulators of energy
homeostasis and metabolism) both in IGB and
LCD groups. A trend toward a inammatory and
metabolic amelioration was observed with both
treatments.
Nausea (3), vomiting (3), bad breath (3),
discomfort (3), belching (3) and atulence
(3).
Fernandes
et al. (28)
(I) 26 and 113, (II) 28.6 and
35.8, (III) NA, (IV) 6 months,
(V) Silimed
(I) -
(II) -
(III) -
The mean EWL was 41% in the patients with obesity
(n=113) and 96% in patients with overweigh
(n=26).
Nausea and pain (50-95%).
Early removal of the IGB (6%).
Courcoulas
et al. (29) (I) 137, (II) 35, (III) LT, (IV) 6
months, (V) ORBERA
(I) 136
(II) 35
(III) LT
The mean WL in the IGB group at the end of the
6,9 and 12 months was 10.2%, 9.1% and 7.6%,
respectively and the reduction in BW and EBW in
IGB group at these months was signicantly higher
than the control group.
Vomiting (75.6%), nausea (86.9%),
abdominal pain (57.5%) and gastric
abnormality (3.1%).
Early removal of the IGB (18.8%).
Al-Subaie
et al. (30)
(I) 51, (II) 32.1, (III) Non-
standard diet program,
(IV) 4 months, (V ) Elipse
(I) -
(II) -
(III) -
The decrease in BW, EBW, BMI and WC was 10.44%,
40.84%, 3.42 kg/m2 and 8.62 cm, respectively.
Vomiting the balloon (1) and early deation
(1).
Early removal of the IGB (5).
Żurawiński
et al. (31)
(I) 63, (II) 58.3, (III) NC,
(IV) 6 months, (V) LexBal
(I) -
(II) -
(III) -
The decrease in BMI was 7.1 kg/m2 and the highest
BMI reduction was recorded in patients in the age
group of 30–39, whereas the lowest value was in
the patients aged 40– 49.
Nausea (57.1%), vomiting (44.4%), general
discomfort (38.1%), atulence (38.1%),
upper abdominal pain (30.2%), heartburn
(17.5%), dehydration and oesophageal
candidiasis (7.9%).
Guedes et
al. (32) (I) 50, (II) 40, (III) NA, (IV) 6
months, (V) Silimed
(I) -
(II) -
(III) -
The mean reduction in BMI, BW, WC, total body
fat and fat free mass was 4.4 kg/m2, 11.7 kg, 9.3
cm, 7. 5 kg and 3.7 kg, respectively. A signicant
improvement was also observed in almost all
aspects of health-related quality of life measured
by (WHOQOL-BREF).
NA
Da Silva et
al. (33) (I) 51, (II) 35.8, (III) LCD, (IV)
6 months, (V) ORBERA®
(I) -
(II) -
(III) -
The mean WL and EWL were 11.9 kg and 42.2%,
respectively. After removal of the IGB (at 6-12
months) the mean WL and EWL were 8.2 kg and
30.3%, respectively.
Abdominal pain (7), nausea (7), vomiting
(5), and spontaneous IGB deation (1).
Genco et
al. (34)
(I) 38, (II) 38.6, (III) 1000-
1200 kcal/day diet, (IV) 4
months, (V) Elipse
(I) -
(II) -
(III) -
The mean reduction in BW, EBW and BMI was
12.7 kg (11.6%), 26% and 4.2 kg/m2, respectively.
Signicant reductions in major co-morbidities
related to metabolic syndrome (HOMA-IR index,
blood glucose, blood pressure, triglycerides, and
WC) were observed.
NA
Reimão et
al. (35)
(I) 40, (II) 32.9, (III) LCD (up
to 1000 kcal/day)+PA, (IV)
6 months, (V) Orbera
(I) -
(II) -
(III) -
There was a signicant reduction in BW (12.3 kg,
13.69%), body fat mass and fat area. Quality of
life (assessed by the Short Form 36 Health Survey)
improved in all eight sections analyzed: mental
health, functional capacity, general health status,
physical aspects, emotional aspects, social aspects,
vitality, and pain.
NA
Foroutan
and
Ardeshiri,
(36)
(I) 52, (II) 39.4, (III) 1000
kcal/day diet, (IV) 6
months, (V) BioEnterics
(I) -
(II) -
(III) -
The mean reduction in BW and BMI was 18.9 kg and
6.9 kg/m2, respectively, at six months after balloon
placement. Although there was an increase in BW
and BMI at 6 months after the balloon removal, the
decrease compared to the baseline values were
14.2 kg and 4.6 kg / m2, respectively.
Nausea and vomiting (NA).
Sullivan et
al. (37) (I) 198, (II) 35.2, (III) LT, (IV)
6 months, (V) OBALON
(I) 189
(II) 35.5
(III) LT
The decrease in BW and BMI in the IGB group
(7.1% and 2.5 kg/m2, respectively) was signicantly
greater.
Nonserious adverse events (91.1%),
bleeding ulcer (1) and early balloon
deation (1).
Alsabah et
al. (38) (I) 135, (II) 33.7, (III) NC, (IV)
4 months, (V) ELIPSE
(I) -
(II) -
(III) -
The decrease in BW and BMI was 13 kg (15.1%) and
4.9 kg/m2, respectively.
Colicky abdominal pain (29), diarrhea
episodes (18), early deation (3), vomiting
the balloon (2), and small bowel obstruction
(1).
Early balloon removal due to intolerance
(3).
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Ulger et al., Intragastric balloon, transpyloric shuttle and obesity
Table 1. Summary of Reported Outcome Data Following Intragastric Balloon Treatment (Results of Recent Studies Published Between the
years of 2015-2020) (continued)
Guedes et
al. (39)
(I) 42, (II) 35.1, (III) NC+LCD
(12 kcal/kg), (IV) 6 months,
(V) Orbera or Spatz
(I) -
(II) -
(III) -
In addition to a signicant reduction in central and
total body fat, there was a signicant decrease in
BW (15.8%), EBW (56.1%) and WC (13.3 cm). On the
other hand, there was an improvement of quality of
life, an increase in physical activity, and a reduction
in energy intake during the IGB treatment.
NA
Jamal et al.
(40)
(I) 112, (II) 34.3, (III) High
protein low calorie diet,
(IV) 6 months, (V ) Elipse
(I) -
(II) -
(III) -
The mean WL at 3, 6, and at date of last follow-up
was 10.7%, 10.9%, and 7.9%, respectively.
Early balloon deation (3) and small bowel
obstruction (1).
Early balloon removal due to intolerance
(6).
Guedes et
al. (41)
(I) 42, (II) 35.1, (III) NC+LCD
(12 kcal/kg), (IV) 6 months,
(V) Orbera or Spatz
(I) -
(II) -
(III) -
The decrease in mean BMI was 5.6 kg/m2. In
addition there was a signicant reduction in insulin,
glucose, HOMA-IR, high-sensitivity C-reactive
protein, triglycerides, and leptin levels. On the
other hand adiponectin/leptin ratio increased.
NA
Madeira et
al. (42)
(I) 40, (II) 39.8, (III) LCD
(1200 kcal/day energy and
1000-1500 mg/d calcium),
(IV) 6 months, (V ) Silimed
(I) -
(II) -
(III) -
There was a signicant decrease in BW (11.5%),
and a signicant increases in carboxyterminal
telopeptide of type 1 collagen and vitamin D
levels after 6 months. On the other hand areal
bone mineral density decreased in the total femur
and radius but increased in the spine. In addition,
cortical bone mineral density increased in the distal
radius but tended to decrease in the distal tibia.
NA
Fittipaldi-
Fernandez
et al. (43)
(I) 94 (600 mL IGB volume)
and 86 (850 mL IGB
volume), (II) 39.5, (III) 10-
15 kcal/kg/day diet, (IV) 6
months, (V) Spatz3
(I) -
(II) -
(III) -
The mean reduction in BMI, BW and EBW was
6.7 kg/m2, 21.5 kg and 18.6 kg, respectively. The
adjustment in IGB volume (250 mL greater IGB
volume) resulted in greater mean WL of 4.35 kg. The
upward adjustment group did not present greater
%TWL, %EWL, or BMI reduction when compared
with the standart IGB volume (600 mL) group.
Spontaneous deation (1.66%), gastric
ulcer (3.32%), Mallory-Weiss syndrome
(0.55%), and gas production inside the
balloon (0.55%)
Early balloon removal (8.32%).
Lopez-
Nava et al.
(44)
(I) 32, (II) 34.9, (III) LCD+LT
(IV) 6 months, (V ) Orbera
(I) -
(II) -
(III) -
The mean reduction in BW at 3, 6, and 12 months
was 13.3%, 15.9%, and 16.8%, respectively. Patients
in the higher gastric retention quartile at baseline
had a 6.2-time higher likelihood ratio for early
balloon removal secondary to intolerance.
NA
Ibrahim et
al. (45) (I) 86, (II) 42.9, (III) NC, (IV) 6
months, (V) MedSil
(I) -
(II) -
(III) -
The mean reduction in BMI was 5.8 kg/m2 and 4.2
kg/m2 at 6 and 12 months, respectively. NA
Intragastric balloon treatment is used only as a bridge to
laparoscopic bariatric surgery by many physicians due
to the fact that IGB application is temporary therapeutic
modality for obesity treatment, and the weight lost after
IGB may be quickly regained (28-80% of the patients
regain the weight they lost within one year following the
removal of the balloon) (19, 20). Because of quick regain
of the lost weight after removal of the gastric balloon,
it has been stated that IGB application combined
with laparoscopic bariatric techniques, instead of IGB
application alone, may give more eective results (19,21).
3.5. General Characteristics of TransPyloric Shuttle
TransPyloric Shuttle placement is one of the minimally
invasive methods intended to treat obesity by reducing
the gastric emptying rate with a spherical silicone
device placed endoscopically in the stomach. The TPS
consists of a small and large spherical bulb connected
by a exible silicone tether. When this device positioned
endoscopically, the large bulb (not as large as the
gas- or water-lled balloons) repeatedly engages the
pylorus during antral contractions, causing intermittent
obstruction, while the other bulb (smaller bulb) passes
freely into the duodenum to position the TPS across the
pylorus (46). The action of large bulb prolongs gastric
accommodation, delays gastric emptying, and produces
early and prolonged satiety.
3.6. Eects of TPS on Obesity Related Comorbidities
and Weight Loss and Complications Caused by the
Technique
To date, the eect of TPS on obesity has been evaluated
in some studies (Table 2). This technique was rst applied
by Marinos et al. (47) in 2013 and it was found that weight
loss was achieved in patients in the 3-6 months period.
However, in this study, it was stated that persistent gastric
ulceration was observed in two patients depending on
the application. In another randomized double-blind trial
(48), it was observed that mean body and excess weight
loss at twelve months was higher in TPS group (9.5% and
30.9%, respectively) compared to control group (2.8%
and 9.8%, respectively). In addition, signicant decreases
in plasma insulin and insulin-resistance level (measured
by HOMA-IR) and signicant improvement in lipid prole
and blood pressure were observed in TPS group. However,
serious adverse events were occurred (none developed
perforation or bleeding) in TPS group (2.5%). Because
of the gastroduodenal ulcers (10.3%) and other adverse
events the device was removed earlier than anticipated
time. Although studies on TPS are limited, similar positive
results were obtained (weight loss, improved quality of
life scores) in the study conducted by Sartoretto et al.
(49), and these positive results enabled the device to be
approved by the FDA on April 16, 2019.
BMI; body mass index, BW; body weight, EBW; excess body weight, EWL; excess weight loss, LCD; low calorie diet, LT; lifestyle therapy, NA; data not available, PA;
physical activity, SMC; Standart medical care, WC; waist circumference, WL; weight loss.
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Ulger et al., Intragastric balloon, transpyloric shuttle and obesity
Table 2. Summary of Reported Outcome Data Following TransPyloric Shuttle
Ref.
TPS Group
(I) n
(II) Initial BKI (kg/m2)
(III) Extra application
(IV) Treatment
period
Control Group
(I) n
(II) Initial BKI
(III) Extra application
Main outcomes Adverse events
Rothstein
et al. (48)
(I) 180
(II) 30-40
(III) NA
(IV) 12 months
(I) 90 (Sham-controlled)
(II) 30-40
(III) NA
The mean reduction in BW in TPS and control groups
were 9.5% and 2.8% at 12 months, respectively.
Greater improvement in cardiometabolic risk factors
(blood pressure, insulin, HOMA-IR, triglyceride, LDL,
and total cholesterol) were observed in TPS group
patients compared to control group patients.
Dyspepsia (NA), nausea (NA), vomiting (NA)
and stomach pain (NA).
Early removal of the device due to
gastroduodenal ulcer (21).
Sartoretto
et al. (49)
(I) 8
(II) 37.2
(III) NA
(IV) 12 months
(I) -
(II) -
(III) -
The mean reduction in BW and EBW was 10.4%
and 33.8 at 6 months. At 12 months these values
further increased to 12.8% and 36.2%, respevtively.
In additon, the decrease in mean BMI was 4.6 kg/m2
at 12 months.
Nausea (NA), reux (NA), cramping (NA),
abdominal pain (NA), bloating (NA) and
ulcer (1).
Marinos et
al.(50)
(I) 20
(II) 36
(III) LCD
(IV) 3-6 months
(I) -
(II) -
(III) -
The decrease in BW, EBW and excess BMI was 8.9%,
25.1%, and 33.1%, respectively in three-month
patients (n=10). On the other hand in six-month
patients (n=10) the decrease in BW, EBW and excess
BMI was 14.5%, 41.0%, and 50.0%, respectively.
Nausea (9), sore throat (7), abdominal pain
(6), diarrhea (5), gastroesophageal reux
disease (4), vomiting (3), constipation (3),
feeling heaviness and bloating (1)
Early removal of the device due to
symptomatic gastric ulcerations (2).
3.7. Overview of Both Techniques
When the studies on IGB in the literature are examined, it
is thought that IGB is an eective endoscopic technique
for patients with obesity to improve comorbidities
accompanying obesity and to reduce the severe
complication or adverse event risk of laparoscopic bariatric
surgery in the preoperative period. Considering that
preoperative weight loss may be the predictive factor of
post-operative weight loss, IGB treatment combined with
laparoscopic bariatric methods may be one of the most
eective techniques in the treatment of morbid obesity.
The positive eects of IGB on obesity-related comorbidities
and weight loss, and the low adverse events rate compared
to other techniques facilitate the patient’s acceptance of
the IGB treatment and highlight the technique over other
methods.
Similar to IGBs, endoscopic TPS placement may be useful
both for primary obesity management and as a bridge to
laparoscopic bariatric surgery. However, the safety prole
of device still needs improvement. The device used in this
method is 85-90% smaller than intragastric balloons, and
this is considered as an advantage; however, more clinical
studies investigating the long term eects (especially in the
period after device removal) and possible complications of
the TPS method are needed.
5. Conclusion and Recommendations
The positive eects of IGB and TPS application on the
gastric emptying rate and the neurohormonal components
that play a role in hunger and satiety provide targeted
weight loss. However, there may be diversities in practical
eects depending on the dierences in the type and
structure of the IGBs. Common features of IGBs and TPS
are: they do not alter stomach or intestinal anatomy, they
are not permanent, and they provide eective weight loss.
In addition, these techniques also have potential to reduce
comedications in patients with T2DM and obesity. The most
signicant dierences between IGBs and TPS are in the severity
and frequency of the complications they cause. The nearly 40-
year history of IGB application in obesity treatment makes
it a safer and more eective approach. Because of the quick
regain of lost weight within a year after the balloon removal,
it should also be noted that IGB application combined with
laparoscopic bariatric techniques, instead of IGB application
alone, may give more eective results. However, for both IGB
and TPS usage should be considered with caution as they are
temporary treatments for a chronic condition. On the other
hand, although TPS has some advantages over IGBs, the
serious adverse events risk is higher, and, therefore, the safety
prole of the TPS still needs to be improved.
6. Contributions to the Field
In this systematic review, the role of the IGB technique, which
is very common in the surgical treatment of obesity, and the
TPS technique, which is expected? to be used more frequently
in the future, in the treatment of obesity were evaluated. All
results and adverse events determined in the reviewed studies
stated without any classication because of helping guide
the clinical decision making and procure better treatment of
obesity. The data obtained and presented may be eective in
the further improvement of both methods.
Conict of Interest
This article did not receive any nancial fund. There
is no conict of interest regarding any person and/or
institution.
Authorship Contribution
Consept: TGÜ, FPÇ; Desing: FPÇ, MT; Supervision: FPÇ,
MT; Funding: - Materials: - Data Collection/Processing:
TGÜ, FPÇ, MT, ÇÖ; Analysis/Interpretation: TGÜ, FPÇ, MT,
ÇÖ; Literature Review: TGÜ, FPÇ, MT, ÇÖ; Manuscript
Writing: TGÜ, ÇÖ; Critical Review: FPÇ, MT.
BMI; body mass index, BW; body weight, EWL; excess weight loss, LCD; low calorie diet, NA; data not available, WL; weight loss
327
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Ulger et al., Intragastric balloon, transpyloric shuttle and obesity
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