Innovations and brief communications 1

Endoscopic sleeve gastroplasty for the treatment of

obesity
A

Authors Gontrand Lopez-Nava1, Manoel P. Galvão2, Immacul da Bautista-Castaño1, Amaya Jimenez1, Teresa De Grado1,
uan Pedro Fernandez-Corbelle1

1
Institutions Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, Madrid, Spain
2
Gastro Obeso Center, Gastrointestinal Surgery, São Paulo, São Paulo, Brazil

submitted 12. April 2014 Background and study aims: Emerging endo- Results: There were no adverse events and all pa-
accepted after revision scopic techniques are minimally invasive and can tients were discharged in less than 24 hours.
15. September 2014
mimic the anatomic alterations achieved by sur- Baseline mean body mass index was 38.5 kg/m2,
gical sleeve gastrectomy. The objective of this and mean age was 45.8 years. Initial body weight
Bibliography study was to evaluate endoscopic sleeve gastro- (108.5 ± 14.9 kg) was significantly reduced. Fol-
DOI http://dx.doi.org/ plasty. lowing the procedure, the mean body weight
10.1055/s-0034-1390766 Patients and methods: This was a prospective, reduction was 8.2 ± 2.5 kg at 1 month (% of initial
Published online: 0.0.
single-center study of 20 patients who under- weight loss 7.6 %; P < 0.05), 13.6 ± 4.8 kg at 3
Endoscopy 2014; 46: 1–4
© Georg Thieme Verlag KG
went flexible endoscopic suturing for endolumin- months (12.4 % weight loss; P < 0.05), and 19.3 ±
Stuttgart · New York al gastric volume reduction. A multidisciplinary 8.9 kg at 6 months (17.8 % weight loss; P < 0.05).
ISSN 0013-726X team provided postprocedure care. Patient status Conclusion: Endoscopic sleeve gastroplasty can
and weight were recorded at baseline, and at 1, 3, be effective for the treatment of patients with
Corresponding author
and 6 months after the procedure. obesity.
Gontrand Lopez-Nava, MD
Bariatric Endoscopy Unit
Madrid Sanchinarro University Introduction dure time associated with suturing limit the ap-
Hospital ! peal of this procedure. Here, we report on a pilot
C/ San Enrique de Osso, 397 Obesity has become a global problem, spanning study of endoscopic sleeve gastroplasty using a
28055 Madrid age, ethnicity, and socioeconomic boundaries [1]. modified suturing method in conjunction with a
Spain Recent data from the National Health and Nutri- multidisciplinary approach for the treatment and
Fax: +34-91-7500203
tion Examination Survey reported that, in the management of obesity in a Spanish population.
glopeznava@digestivolopeznava.
com
United States, more than one-third of adults and
17 % of children and adolescents are obese [2].
The Organization for Economic Co-operation and Patients and methods
Development recently reported that 30 % of ado- !
lescents and over 40 % of adults are currently Patients
overweight, with rates in the next 10 years ex- All procedures were conducted in accordance
Endoscopy 2014-10677 "071", 7.10.14, seitenweise

pected to rise by at least 10 % [3]. Obesity, and its with good clinical practice and within the guide-
associated co-morbidities, is now considered lines of the Declaration of Helsinki for studies
among the highest contributors to the global bur- using human subjects. The study was registered
den of disease [4]. with the institutional review board of the Sanchi-
A substantial body of evidence suggests that sur- narro University Hospital of Madrid. Written in-
gical treatment for obesity, such as sleeve gas- formed consent was obtained from all patients.
trectomy or Roux-en-Y gastric bypass, results in Data were collected prospectively for analysis.
the most significant and sustained weight loss. The specific indications for the procedure were
However, surgery is risky, and the altered anato- based on obesity parameters (body mass index
my is difficult to reverse [5]. [BMI] 30 – 49 kg/m2), and the willingness and abil-
A recent preliminary report demonstrated that ity of patients to be treated by a multidisciplinary
the use of endoscopic sleeve gastroplasty for the team for at least 1 year. The procedure was
treatment of obesity is safe and feasible, and re- contraindicated in patients with potentially
sulted in both significant weight loss and altered bleeding lesions (e. g. ulcers and acute gastritis)
patient eating behaviors [6]. However, the lack of and preneoplastic findings. Coagulopathy and
long-term follow-up data and the lengthy proce-
█ Proof copy for correction only. All forms of publication, duplication or distribution prohibited under copyright law. █

Lopez-Nava Gontrand et al. Endoscopic sleeve gastroplasty for obesity … Endoscopy 2014; 46: 1–4
 2 Innovations and brief communications

psychiatric disorders were excluded by blood tests and psycholo- intra-abdominal pressure was recommended during the first
gist interview, respectively. month. Initially, walking was encouraged, with a progressive in-
crease in intensity as the diet progressed.
Endoscopic sleeve gastroplasty procedure
To perform endoluminal gastric volume reduction, a cap-based Outcome assessment
flexible endoscopic suturing system (OverStitch; Apollo Endosur- The baseline and follow-up examinations included the assess-
gery, Inc., Austin, Texas, USA) was used mounted onto a double- ment of weight and height, which were measured using calibra-
channel endoscope (GIF-2T160; Olympus Medical Systems Corp., ted scales and wall-mounted stadiometer, respectively. For all
Tokyo, Japan) to achieve full-thickness, running sutures through measurements, patients wore indoor clothing and no shoes.
the gastric wall from the antrum to the fundus, as previously re- BMI was calculated as weight in kilograms divided by the square
ported [6]. The procedure was performed with the patient in the of height in meters. The outcomes after 1, 3, and 6 months of
left lateral decubitus position and under general anesthesia with follow-up were: 1) change in body weight; 2) percentage loss
endotracheal intubation. An esophageal overtube (US Endoscopy, of initial body weight; 3) percentage of excess body weight loss
Mentor, Ohio, USA) was used to facilitate both atraumatic passage (percentage of weight lost compared with excess weight, de-
of the endoscope with the suturing device and repeated intuba- fined as current weight minus the weight corresponding to a
tion with an endoscope when needed. Carbon dioxide gas insuf- BMI of 25 kg/m2).
flation was used to distend the gastric lumen.
We refer to this novel technique as endoscopic endoluminal Statistical analysis
greater curvature plication. An initial endoscopic evaluation was This was a prospective pilot study and was therefore carried out
performed to exclude any contraindications to the gastric inter- without a power calculation. For descriptive purposes, the mean
vention. Argon plasma coagulation (APC) was used to mark stitch and SD were calculated for each outcome. The association be-
sites along the anterior wall, greater curvature, and posterior tween changes in body weight parameters and changes in differ-
wall. The reduction began with the gastric body, suturing distal ent follow-up groups was also analyzed using the Student t test
to proximal, and beginning at the incisura angularis and finishing for pairs. All P values presented are two-tailed, and statistical sig-
in the fundus. A triangular stitch pattern was initiated starting at nificance was defined a priori as P < 0.05. Data analyses were per-
the anterior wall, then the greater curvature, and finally the pos- formed using SPSS 17.0 (SPSS Inc., Chicago, Illinois, USA).
terior wall, after which the pattern was repeated in reverse, tar-
geting the APC markings in order to maintain the correct orienta-
tion of the stomach. Each triangular stitch pattern consisted of Results
approximately 3 – 6 full-thickness stitches, before the suture was !
cinched forming a plication. The plication suture pattern was re- The treatment group consisted of 20 patients (16 women and 4
peated approximately 6 – 8 times in the direction of the fundus. men) with follow-up for 6 months at the Bariatric Endoscopy
All suturing was performed using a straight endoscope position. Unit of Madrid Sanchinarro University Hospital between May
A catheter-type tissue screw (Helix device; Apollo Endosurgery) 2013 and January 2014. All patients selected for the procedure
ensured full-thickness stitch placement, which is critical to the underwent successful gastroplasty. The mean procedure time
durability of each plication. was 75 minutes (range 40 – 120 minutes).
The goal of the procedure is to reduce the gastric cavity to resem- The initial mean BMI was 38.5 + 4.8 kg/m2 (range 30.2 –
ble a tubular lumen along the lesser curvature, with the greater 47.0 kg/m2), and initial weight was 108.5 + 14.9 kg (range 83.4 –
curvature replaced by a line of cinched plications. The suturing 142.0 kg). The mean age was 45.8 + 8.4 years (range 28.5 – 59.6
technique is intended not only to reduce the stomach diameter, years). Oral contrast studies were performed as follows: the day
but also to shorten it substantially through an accordion effect. after the procedure 20/20 patients (100 %); 3 months postproce-
After the procedure, a second-look endoscopy was performed to dure 15/20 patients (75 %); 6 months postprocedure 5/20 pa-
assess the final shape, to examine for any gaps that would require tients (25 %). A total of 10 patients (50 %) consented to an endos-
supplemental closure, and to assess for bleeding. Voluntary oral copy at 6 months.
contrast studies were scheduled to assess the gastroplasty at 24 The oral contrast study conducted on the day after the procedure,
hours, 3 months, and 6 months postprocedure. An endoscopy when compared with the studies at 3 and 6 months postproce-
Endoscopy 2014-10677 "071", 7.10.14, seitenweise

was planned at 6 months postprocedure on a voluntary basis. Im- dure, did not show any significant change in the gastroplasty
mediate postprocedure care included overnight observation, li- configuration. The endoscopy at 6 months, performed in 10 pa-
quid diet at 12 hours postprocedure, and analgesia if needed. All tients who agreed to the procedure, showed suture stability
patients were scheduled to be discharged within 24 hours. with intact gastroplasties.
●
" Table 1 shows the initial values and the changes at 1, 3, and 6

Follow-up multidisciplinary bariatric team months following the procedure. All differences between the ini-
Postprocedure care included close follow-up by a nutritionist and tial weight and values at 1, 3, and 6 months were statistically sig-
a psychologist weekly or bi-weekly, with an additional emphasis nificant (P < 0.05). There were no adverse events, except for intra-
on initiating an exercise program. The follow-up program, orga- procedural bleeding in two patients that was controlled with in-
nized by the team, included diet, psychological support, physical jection therapy. Following blood work, barium radiograph, and a
activity, counseling with a planned schedule, as well as a sche- check to ensure the prescribed postprocedure diet was well tol-
dule for future visits. erated, all patients were discharged on the day following the pro-
A liquid diet was started on the day before the procedure and was cedure.
continued for at least 2 weeks after the procedure. The patient
then progressed from hypocaloric liquids to small semisolid
meals over 4 weeks. An exercise plan that avoided an increase in
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Lopez-Nava Gontrand et al. Endoscopic sleeve gastroplasty for obesity … Endoscopy 2014; 46: 1–4
 Innovations and brief communications 3

Variable Initial 1 month 3 months 6 months Table 1 Changes in weight

n = 20 n = 20 n = 20 n = 20 (mean ± SD) following endoscopic
endoluminal greater curvature
Weight, kg 108.5 ± 14.9 100.2 ± 13.8 94.9 ± 13.2 87 ± 11.3
plication for the treatment of obe-
BMI, kg/m 2 38.5 ± 4.8 35.6 ± 4.7 33.7 ± 4,7 31.9 ± 4.9
sity.
Total weight loss, kg – 8.2 ± 2.5 13.6 ± 4.8 19.3 ± 8.9
Weight loss, % – 7.6 ± 2.2 12.4 ± 3.9 17.8 ± 7.5
Excess weight loss, % – 24.6 ± 14.3 39.3 ± 19.9 53.9 ± 26.3
BMI, body mass index.

Discussion vasive weight loss procedures are appealing, and provide an op-
! portunity to reach a greater number of patients who could bene-
In 2013, Abu Dayyeh et al. [6] published data demonstrating the fit from a bariatric intervention.
feasibility and safety of endoscopic sleeve gastroplasty in four pa- There is currently a void in management choices after lifestyle
tients. The current study is the first prospective study to report modification has either failed or reached a plateau: the choice is
results for a larger sample of 20 patients and with follow-up of 6 between drug therapies and surgery (lap band, sleeve gastrect-
months. The results of this study indicate that this technique, omy, and Roux-en-Y gastric bypass). The weight loss achieved by
when combined with a multidisciplinary bariatric team ap- the current endoscopic procedure, although not commensurate
proach, can be an effective, safe, and well-tolerated procedure with surgical therapy, can allow this management void to be fil-
for the treatment of patients with obesity. led, perhaps most reasonably in patients within the BMI range of
Regular contact with a multidisciplinary team has been shown to 30 – 35 kg/m2. What is unique about this endoscopic procedure is
be critical in maximizing patient outcomes [7]. Sacks et al., in that it can conveniently be repeated throughout a patient’s jour-
2009, randomly assigned 811 overweight adults to four diets ney in obesity management. This endoluminal procedure allows
with different macronutrient composition. The participants for convenient revision, triggered by weight gain and, more im-
were offered group and individual instructional sessions for 2 portantly, increased meal volume accommodation, which may
years. Satiety, hunger, satisfaction with the diet, weight loss, and suggest breakdown of plication(s). We feel that this is an impor-
attendance at group sessions were similar for all diets. Atten- tant concept to be considered.
dance, however, was strongly associated with weight loss (0.2 kg These 6-month pilot results, together with the existing safety
per session attended). This aspect of care was carefully incorpora- profile of sleeve gastroplasty, suggest that this procedure may
ted into the current study. serve as an early bariatric intervention, allowing physicians to
The long-term effects of diet, exercise, and medical therapy on treat their obese patients in a safe, less-invasive manner, which
long-term weight loss and maintenance are poor. With respect may allow for the treatment of a wider segment of the obese pop-
to durable weight loss, some studies have demonstrated bariatric ulation.
surgery could reduce long-term mortality associated with obesi-
ty [8, 9]. Bariatric surgery has associated risks and serious com- ((█ Dear author, please put links to ● " Fig. 1 and ●
" Fig. 2 in the

plications. Despite the known benefits, these risks deter many text. Where shall the figures be placed? █))
patients from even considering an interventional option. There
is resistance to these treatments from both providers and insur-
ers. Consequently, each year only a small percentage (< 2 %) of
morbidly obese patients actually undergo surgery [5]. It is also
an insurmountable task to provide surgery for the entire obese
population regardless of the hazards. For these reasons, less-in-

Fig. 1 Postprocedure (next day) barium radio-

graphs.
Endoscopy 2014-10677 "071", 7.10.14, seitenweise

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Lopez-Nava Gontrand et al. Endoscopic sleeve gastroplasty for obesity … Endoscopy 2014; 46: 1–4
 4 Innovations and brief communications

Competing interests: None

References
1 Finucane MM, Stevens GA, Cowan MJ et al. National, regional, and global
trends in body-mass index since 1980: systematic analysis of health
examination surveys and epidemiological studies with 960 country-
years and 9.1 million participants. Lancet 2011; 377: 557 – 567
2 Ogden CL, Carroll MD, Kit BK et al. Prevalence of childhood and adult
obesity in the United States, 2011-2012. JAMA 2014; 311: 806 – 814
3 University of Illinois at Chicago. The 10 healthiest states in America.
Available from: http://healthinformatics.uic.edu/infographics/10-
healthiest-states-in-america-infographic/ Accessed: 18 July 2014
4 Bloom DE, Cafiero ET, Jané-Llopis E et al. The global economic burden of
noncommunicable diseases. Geneva: World Economic Forum; 2011
5 Boza C, Gamboa C, Salinas J et al. Laparoscopic Roux-en-Y gastric by-
pass versus laparoscopic sleeve gastrectomy: a case-control study and
3 years of follow-up. Surg Obes Relat Dis 2012; 8: 243 – 249
6 Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a
potential endoscopic alternative to surgical sleeve gastrectomy for
treatment of obesity. Gastrointest Endosc 2013; 78: 530 – 535
7 Sacks FM, Bray GA, Carey VJ et al. Comparison of weight-loss diets with
different compositions of fat, protein, and carbohydrates. N Engl J Med
2009; 360: 859 – 873
8 Adams TD, Gress RE, Smith SC et al. Long-term mortality after gastric
bypass surgery. N Engl J Med 2007; 357: 753 – 761
9 Sjostrom L, Narbro K, Sjostrom D et al. Effects of bariatric surgery and
mortality in Swedish obese subjects. N Engl J Med 2007; 357: 741 –
752

Fig. 2 Endoscopic view. a Suturing in progress, before cinching the suture.

b Luminal view of the gastric body during the procedure.
Endoscopy 2014-10677 "071", 7.10.14, seitenweise

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Lopez-Nava Gontrand et al. Endoscopic sleeve gastroplasty for obesity … Endoscopy 2014; 46: 1–4