ARTICLE 1

Endoscopic Sleeve Gastroplasty in 109 Consecutive

ENDOSCOPY
Children and Adolescents With Obesity: Two-Year
Outcomes of a New Modality
Aayed Alqahtani, MD, FRCSC, FACS1, Mohamed Elahmedi, MBBS1, Yara A. Alqahtani, MD1 and Abdullah Al-Darwish, MD1

OBJECTIVES: Endoscopic sleeve gastroplasty (ESG) uses full-thickness sutures that restrict the stomach to a sleeve-
like configuration. There is no published evidence on endoscopic tissue apposition techniques in
pediatric patients. In this article, we report our ESG experience with the first 109 pediatric patients with
obesity who underwent ESG under our care.
METHODS: ESG was offered as a day-case procedure under a standardized protocol and clinical pathway that
included surgical, medical, and endoscopic modalities for the treatment of pediatric and adult obesity.
ClinicalTrials.gov Identifier: NCT03778697.
RESULTS: The 109 patients in this study had a baseline body mass index and age of 33.0 6 4.7 and 17.6 6 2.2
(range: 10–21) years, respectively. Ninety-nine (90.8%) were females. The mean procedure time was
61 6 19 minutes. The mean % total weight loss at 6, 12, 18, and 24 months was 14.4% 6 6.5%,
16.2% 6 8.3%, 15.4% 6 9.2%, and 13.7% 6 8.0%, respectively. Fourteen adolescents visited the
ambulatory clinic for analgesia. One patient (aged 19.8 years) requested removal of endoscopic
stitches due to abdominal pain, and another underwent Redo-ESG for insufficient weight loss. There
were no blood transfusions, emergency admissions, mortality, or significant morbidity.
DISCUSSION: In this first study to date on ESG in pediatric patients, we observed that the procedure is safe and
effective in children and adolescents with obesity. Significant weight loss occurs during the first 2 years
without mortality or significant morbidity, and this weight loss seems to be maintained.
Am J Gastroenterol 2019;00:1–6. https://doi.org/10.14309/ajg.0000000000000440

INTRODUCTION Endoscopic bariatric therapy (EBT) is an emerging, rapidly

Approximately 8% of US children and adolescents have severe
(class II–III) obesity, which is defined as having a body mass
index (BMI) that is $120% of the 95th percentile for age and sex
(1). Although evidence supportive of bariatric surgery as a vi-
able solution for severe childhood obesity is rapidly accumu-
lating (2–13), it is still not widely adopted in treating children
and adolescents. Currently, less than 4 per 10,000 severely
obese children and adolescents undergo weight loss surgery
(14). Access to care and specialist referral preferences continue
to hinder the availability of bariatric surgery as an option for
children and adolescents with severe obesity (15). In addition,
not all pediatric patients with obesity are candidates for weight
loss surgery (16). The latest guidelines that support bariatric
surgery in adolescents recommend offering surgery to those
with class III obesity irrespective of comorbidity status, and
class II obesity if the child/adolescent has 1 or more comor-
bidities (17).
evolving field that aims to serve as a middle ground between
medical weight loss strategies and bariatric surgery (18). Endo-
scopic sleeve gastroplasty (ESG) is a procedure that restricts the
stomach to a sleeve-like configuration by using full-thickness
sutures that plicate the greater curvature of the stomach. Our
center has a vast experience in ESG (19–21). Our observation
extending up to 2 years after ESG in adults demonstrates that the
procedure can safely induce sustained weight loss. In addition,
emerging data from adult populations show an acceptable safety,
tolerability, and efficacy profile (22,23).
Currently, there are no reports on EBT in children and ado-
lescents. Our institution has been running a standardized pro-
spective outcomes study on pediatric bariatric surgery since 2008
(2,7). We incorporated ESG into our pediatric bariatric protocol
after analysis of adult data confirmed its safety and efficacy (19).
In this study, we analyze the outcomes of ESG in children and
adolescents who underwent the procedure under our care.

1
Department of Surgery, College of Medicine, King Saud University & New York Medical Center, Riyadh, Saudi Arabia. Correspondence: Aayed R. Alqahtani, MD, FRCSC, FACS.
E-mail: qahtani@yahoo.com.
Received May 8, 2019; accepted September 24, 2019; published online October 24, 2019

© 2019 by The American College of Gastroenterology The American Journal of GASTROENTEROLOGY

Copyright © 2019 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited.
 2 Alqahtani et al.
METHODS
Pediatric bariatric protocol
We incorporated ESG into our standardized pediatric bariatric
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clinical pathway with few modifications (7). Briefly, we relied on
BMI percentile instead of absolute BMI cutoffs. Patients were
offered enrollment in our pediatric weight loss program if their
BMI was higher than the 95th percentile for age and sex
(17,24,25). Those with a BMI that is higher than 120% of the
95th percentile were enrolled in the interventional protocol if
they failed to lose satisfactory weight during a period of at least 6
months (Figure 1). Based on age eligibility, recommended
interventions included medication-assisted lifestyle counseling
and EBT, which comprises intragastric balloons and ESG. The
choice of intervention is based on patient and parent preference
after counseling on the risks and benefits of each solution. We
also adopted relevant parts of our protocol for ESG in adult
patients with drug dose adjustment for pediatric patients as
indicated (19). The study received local institutional review
board approval, and its protocol has been registered with
ClinicalTrials.gov Identifier: NCT03778697.
Procedure protocol
ESG was performed on a day-case basis. Candidates fasted from
midnight. There were no major differences comparing the tech-
nique in pediatric and adult age groups, and ESG was performed
Figure 1. Flowchart describing the multidisciplinary pediatric interventional weight loss program used at our center, which includes medical management,
endobariatric therapy, and bariatric surgery.
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as previously described (19). However, insufflation was kept to
a minimum, and the helix was rotated no more than 1 ½ times to
pull the gastric wall in younger age groups. Patients were dis-
charged on the evening of the procedure with unrestricted, readily
access to the study site’s ambulatory clinic in case of significant
pain, palpitations, fever, dizziness, or persistent vomiting. The
first follow-up visit was scheduled within 2 weeks after ESG.
Monthly follow-up was planned for the first year with 3-month
visits afterward. Dietary recommendations were based on a pre-
vious study of bariatric surgery in pediatric patients (7). Post-
procedure milestones reported in this study were the first-, third-,
sixth-, ninth-, 12th-, 18th-, and 24th-month visits.
Adiposity change analysis
Weight-related calculations were performed based on the In-
ternational Obesity Task Force BMI cutoff for sex- and age-
specific healthy BMIs (26). To allow for comparison with current
and future literature, we reported weight, weight z-score, weight
change, weight z-score change, BMI, BMI z-score, BMI change,
BMI z-score change, percent excess weight loss (%EWL), and
percent total weight loss (%TWL) from each postprocedure
milestone. %EWL calculation was based the US Centers for
Disease Control and Prevention data, using the 95th BMI per-
centile for age and sex as a reference (27). Respective z-scores were
calculated using the lambda-mu-sigma method developed by
VOLUME 00 | MONTH 2019 www.amjgastro.com
 Endosleeve in Pediatric Patients 3

Cole (28). The lambda-mu-sigma parameters we used were de- 13.7% 6 8.0, respectively (Table 2). There were no significant
rived from the respective growth charts developed by the Centers differences in weight loss comparing those aged 10 to 14 years
for Disease Control and Prevention. The mean %TWL of pedi- with those aged 14 to 18 years or adults aged .18 years (Figure 2;
atric age groups and previously published results in adult patients P value: .0.05 at all postprocedure visits).

ENDOSCOPY
were compared using 1-way analysis of variance (19). At the time of ESG, 6 adolescents had symptoms of obstructive
sleep apnea, 2 had hypertension, and 2 had prediabetes. All
Comorbidity assessment comorbidities were in complete remission at the 3-month visit,
Comorbidities were defined as revealed in our previous studies with no recurrence until the last follow-up visit. There were no
(2–7,29) and in accordance with the American Society for dropouts. All patients who missed a follow-up visit attended
Metabolic and Bariatric Surgery Outcomes Reporting Stand- subsequent follow-ups, and their respective data points were
ards (30). Hypertension was defined as systolic or diastolic analyzed accordingly (Table 2).
blood pressure that is higher than the 95th percentile for sex, A total of 14 adolescents visited the ambulatory clinic during
age, and height. Prehypertension was defined as systolic or the first postprocedure week. Three of those patients visited the
diastolic blood pressure levels between the 90th and 95th per- clinic twice with complaints of abdominal pain. At the clinic, the
centiles for age, sex, and height (31). Dyslipidemia was defined adolescents received analgesia, intravenous fluids, and anti-
according to the report of the expert panel on integrated spasmodics. One patient, who visited the clinic once, requested
guidelines for cardiovascular health and risk reduction in removal of endoscopic sutures due to abdominal pain 3 days after
children and adolescents (32). Diabetes and prediabetes were the procedure. Endoscopic suture removal was performed, and
diagnosed according to the American Diabetes Association the patient was discharged 2 hours later. Pain resolved after the
definition, which used a cutoff point of 7.0 mmol/L for diabetes procedure, and there were no complaints at subsequent follow-
and 5.5 mmol/L for prediabetes (33). Obstructive sleep apnea up. One adolescent underwent redo-ESG 1 year after primary
was assessed clinically through the Pediatric Sleep Question- ESG due to weight regain. There were no adverse events, bleeding,
naire (34). Standardized case report forms were used to capture mortality, or unplanned admissions.
data from the baseline and postprocedure visits.
DISCUSSION
RESULTS This study demonstrates that ESG can safely induce significant,
The data set included a total of 109 children and adolescents from sustained weight loss in adolescents with obesity. The mean BMI
a total of 1,928 patients who underwent ESG as a primary pro- z-score dropped from an average of 2.0 to 1.3 (corresponding to
cedure (5.7%). The pediatric group included in the study had an the 90th percentile) within the first 9 months after the procedure.
average age of 17.6 6 2.2 years (range: 10–21 years; Table 1). Weight loss seemed to be sustained afterward; study participants
Females comprised 91.7% of the study group, and all patients lost 12 kg by the 18-month visit, and about two-thirds of excess
were of Middle Eastern descent. Baseline BMI and BMI z-score weight was lost by the end of 2 years of follow-up. In addition, all
were 33.0 6 4.7 kg/m2 and 2.0 6 0.5, respectively (Table 2). The obesity-related comorbidities suffered by the obese patients un-
mean procedure time was 61.0 6 19 minutes. The mean %TWL at derwent complete remission. Last, there were no severe adverse
1, 3, 6, 9, 12, 18, and 24 months was 8.8% 6 1.5%, 10.7% 6 3.7%, events, prolonged hospital stay, or mortality.
14.4% 6 6.5%, 16.0% 6 8.5%, 16.2% 6 8.3%, 15.4% 6 9.2%, and EBT is a recent evolution in obesity management. Options
include gastric balloons, tissue apposition procedures, and nu-
trient diversion therapies (35). Intragastric balloons have long
been sought as safe interventions in pediatric patients. Although
Table 1. Age distribution in children and adolescents who
balloons have a good safety profile, weight loss is highly variable,
underwent ESG in the present study
and regain occurs in almost all cases after balloon explantation
(36–38). In addition, there are no data on intragastric balloons
Age N %
in children younger than 10 years (39). This might be due to
10 1 0.9 a concern that gastric volume in children is too low to safely
11 1 0.9 tolerate the presence of a gastric balloon. In our center, we
12 1 0.9
preferred not to offer ESG to children younger than 10 years at
the current stage. The Apollo OverStitch system (Apollo
13 3 2.8 Endosurgery, Austin, TX) might not be safe for use in young
14 3 2.8 children. The GIF-2TH180 double-channel scope (Olympus,
15 17 15.6 Tokyo, Japan) that is used with the OverStitch system has an
outer diameter of 12.2 mm. Together with the OverStitch sys-
16 18 16.5
tem, the diameter of the end cap is 16.4 mm in closed position
17 13 11.9 and 25 mm in open position (40). Previous studies suggest that
18 15 13.8 the esophageal diameter in younger age groups is close to
19 21 19.3 10 mm (41).
Endoscopic nutrient diversion therapies are still in infancy,
20 12 11.0
with scarce, preliminary evidence that is limited to adult series.
21 4 3.7 On the other hand, tissue apposition techniques have demon-
Mean age 6 SD, yr 17.6 6 2.2 strated safety in adults (18). This is the first study that inves-
tigates the role of a tissue apposition procedure in children and
ESG 5 endoscopic sleeve gastroplasty.
adolescents. In our experience, there were no major technique

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 4 Alqahtani et al.

Table 2. Anthropometric changes of children and adolescents who underwent ESG in our center

BMI, kg/m2 BMI z-score BMI change Weight change, kg %TWL %EWL N, n
ENDOSCOPY

Baseline 33.0 6 4.7 2.0 6 0.5 — — — — 109, 109

1 mo 31.0 6 5.3 1.7 6 0.6 23.0 6 0.5 27.4 6 1.7 8.8% 6 1.5% 53.5% 6 42.9% 109, 109
3 mo 30.1 6 6.8 1.5 6 0.5 23.7 6 1.4 28.7 6 3.2 10.7% 6 3.7% 61.4% 6 39.3% 104, 94
6 mo 29.5 6 3.7 1.5 6 0.6 24.4 6 2.4 210.4 6 5.6 14.4% 6 6.5% 80.1% 6 63.3% 90, 82
9 mo 28.6 6 5.3 1.4 6 0.4 25.5 6 3.5 212.9 6 6.5 16.0% 6 8.5% 80.5% 6 55.4% 84, 69
1 yr 27.6 6 6.2 1.3 6 0.8 25.7 6 4.0 213.5 6 6.7 16.2% 6 8.3% 87.1 6 59.5 51, 43
18 mo 28.3 6 6.0 1.4 6 0.6 25.3 6 3.6 212.0 6 7.2 15.4% 6 9.2% 70.9 6 55.5 29, 24
2 yr 30.0 6 6.8 1.5 6 0.6 24.5 6 3.8 29.0 6 6.7 13.7% 6 8.0% 63.8 6 52.3 20, 17

No patients dropped from the study (defined as being unreachable after missing 2 consecutive follow-up visits). Patients who missed an assigned follow-up visit were not
included in the analysis of that visit. However, they attended subsequent follow-ups, and their data points were included in the analysis accordingly.
ESG, endoscopic sleeve gastroplasty; BMI, body mass index; %TWL, % total weight loss; %EWL, % excess weight loss; N, total number of patients eligible for the respective
follow-up visit; n, number of patients seen at the respective follow-up visit.

differences between pediatric and adults patients. However, the
stomach is smaller, and the gastric wall is thinner in younger
age groups. This is especially relevant in the fundus, where
tissue is thinner. For this reason, we prefer to perform the
procedure with minimal insufflation in pediatric patients. In
addition, we believe that the helix should not make more than
1-½ turns while attempting to grasp the stomach to avoid
damaging surrounding tissue. In contrast to other endoscopic
plication methods, ESG uses full-thickness sutures that aim to
maintain the stomach in a durable, sustained configuration
(22). Weight loss outcomes were uniform in children and
adolescents in this study. No significant differences in weight
loss comparing different pediatric age groups with data from
adult series (19). These results suggest that weight loss is du-
rable across pediatric and adult ages for at least 2 years of
follow-up in most patients (Figure 2).
Weight loss after ESG in the adolescents in our study group
follows a similar profile to weight loss after bariatric surgery in
adolescent studies (3–6,11–13,42). Alqahtani’s study on laparo-
scopic adjustable gastric banding (LAGB) in adolescents reported

Figure 2. Mean percent total weight loss after endoscopic sleeve gastroplasty in different age groups. Adult data were derived from Ref. (19). BMI, body
mass index.

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an average %EWL of 60% at 1 year. Our ESG group lost 80% of
their excess weight during the first year after the procedure.
This outcome seems similar to that attained by O’Brien’s et al.
(43) clinical trial on gastric banding in adolescents where the
group lost 79% of their excess weight. The TeenLABS group
reported weight loss of 10 kg 3 years after gastric banding.
Weight loss reached 13.5 kg on average 1 year after ESG in the
present study. Overall, it seems that weight loss after ESG is at
least similar to, or higher than, weight loss after gastric banding
in adolescents. This observation is supported by studies in
adults. In an article that compared morbidity, length of stay,
and weight loss after ESG, laparoscopic sleeve gastrectomy
(LSG), and LAGB, the authors concluded that ESG is safer than
both LSG and LAGB. In addition, they found that weight loss
after ESG falls between LAGB and LSG (44). A retrospective
review by Fayad et al. (45) found that although ESG is safer than
LSG, it induces less weight loss. ESG was also found to be less
likely to induce new-onset gastroesophageal reflux disease in
Fayad’s study. Last, ESG is reversible; the patient who un-
derwent reversal in this study had no residual complaints. This
is similar to our experience in adults, where 3 patients un-
derwent uneventful reversal (19).
All obesity-related comorbidities suffered by the children and
adolescents in this study were in complete remission after the
procedure. This remission rate is higher than what we observed in
our series of adult patients who underwent ESG (19). It is also
higher than the rates we observed with severely obese children
and adolescents who underwent sleeve gastrectomy (4). However,
baseline BMI in the current study is much lower compared with
that of patients who underwent LSG under our care (5); The BMI
z-score of those who underwent ESG was 2.0 6 0.5 compared
with 3.0 6 0.4 for those who underwent LSG (3). We believe that
ESG should be offered to overweight and obesity considering the
procedure’s safety and reversibility, knowing that severity of ad-
iposity and duration since onset of comorbidity are known factors
that impact remission after interventional weight loss in adult
series (46).
This is the first study that reports on an endoscopic tissue
apposition technique in children and adolescents. It seems that
ESG can be safely positioned between bariatric surgery and
medical management of obesity in multidisciplinary pediatric
obesity management algorithms. We recommend including ESG
as a potential treatment option for children and adolescents with
obesity.
CONFLICTS OF INTEREST
Guarantor of the article: Aayed R. Alqahtani, MD, FRCSC, FACS.
Specific author contributions: A.R.A.: planning and conducting the
study, performed procedures, patient follow-up, supervision of data
collection and analysis, and drafting of the manuscript. M.E.: con-
ducting the study, patient follow-up, supervision of data collection
and analysis, and drafting of the manuscript. Y.A.A.: planning and
conducting the study, patient follow-up, data collection, and drafting
of the manuscript. A.A.-D.: patient follow-up, data management,
supervision of data analysis, and drafting of the manuscript.
Financial support: None to report.
Potential competing interests: A.R.A. is a consultant for Apollo
Endosurgery, which manufactures the OverStitch system used in
endoscopic sleeve gastroplasty. The other authors have no potential
conflicts of interest. ClinicalTrials.gov Number: NCT03778697.
© 2019 by The American College of Gastroenterology
Copyright © 2019 by The American College of Gastroenterology. Unauthorized reproduction of this article is prohibited.
Endosleeve in Pediatric Patients 5
Study Highlights
WHAT IS KNOWN
3 Although supervised weight management programs improve
ENDOSCOPY
cardiometabolic health and quality of life of children and
adolescents with obesity, sustainable sufficient weight loss is
seldom achieved.
3 The evolution of EBTs has resulted in rapid accumulation of
evidence supportive of ESG as a viable solution for adult
obesity.
WHAT IS NEW HERE
3 ESG is safe and effective in children and adolescents aged
10–21 years.
3 ESG induces sustained weight loss for at least 2 years of
follow-up without mortality or significant morbidity in children
and adolescents with obesity.
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