Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients

//Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients

Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients

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Official Title:

Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients

Basic Trial Information

Phase Type Age Protocol IDs Status
N/A Interventional 18 – 70 Years Endoscopic Gastric Plication Not yet recruiting

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Dr. Tapan Shah

Dept of Bariatric Surgery

Institute of Gastroenterology and Liver Surgery

Trial Summary

Endoscopic Plication is a new technique of reducing the size of stomach generally consider as a restrictive technique. This technique is very similar to sleeve gastrectomy but performed endoscopically and the patient need not undergo major surgical interventions.

Traditional laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a technically challenging endeavor since prior abdominal surgeries increase the amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not candidates for laparoscopic weight loss surgery because of inability to tolerate pneumoperitoneum due to underlying physiologic dysfunction.

Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8 Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11

The intent of this study is not to demonstrate endoscopic suturing to be a primary option for weight-loss surgery. Preliminary reports have shown such procedure is technically feasible but not durable and the effects of the procedure varied widely among the study participants.12 The investigators view this technology as a bridge for morbidly obese patients, who will need subsequent surgery for another surgical disease, to improve their body habitus and decrease their postoperative morbidity and mortality. The aims of the investigators study are:

– Feasibility of endoscopic gastric sleeve plication

– Define the technical aspects of endoscopic suturing for sleeve plication

– Provide long-term follow-up for both weight loss and resolution of their co-morbidities

– Photographic evidence of the stomach after endoscopic plication during any other laparoscopic surgery
There are several advantages for the proposed study. First it avoids entering the intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13, 14

The implications of this study can be far-reaching. Once efficacy is demonstrated where enough weight loss is achieved that patients can safely and quickly undergo their incisional hernia surgery, the investigators can then conduct a retrospective case-control cross-matched study to further delineate its true benefit. If there is a true benefit, then a randomized control study can be employed in the future.


Inclusion Criteria:

  • Body mass index (BMI) ³35 kg/m2
  • Documented incisional hernia
  • Age ≥ 18 years old

Exclusion Criteria:

  • Prior gastric surgery
  • Prior bariatric surgery
  • Gastroesophageal reflux disease (GERD)
  • Enterocutaneous fistula (ECF)
  • Unable to tolerate general anesthesia
  • Portal Hypertension
  • Underlying coagulopathy

Detailed Description

The most effective weight loss procedures in the United States are both roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG)where the majority are performed laparoscopically. Estimated excess body weight loss (EBWL) is >50% at the end of one year. However, nearly 20% of patients fail to meet the estimated EBWL or they may experience weight gain recidivism.

The first step is nutritional counseling, medically supervised diets, and medical therapy. Surgery would be for those who still fail to lose weight despite the aforementioned efforts. It is hypothesized that failure of weight loss for RYGB is gastrojejunostomy (GJ) dilation defined as >2 cm. Surgical treatment would require revision of this dilation. Unfortunately many of these revision procedures cannot be done laparoscopically given dense intra-abdominal adhesions. This will require conversion to an open surgery in a morbidly obese patient thus raising postoperative morbidity and mortality estimated to range between 15%-50%.

The investigators propose to use the endoscopic suturing device designed by Apollo EndoSurgery to decrease the GJ dilation to 5-6 mm thus causing restriction, delayed food transit time, and promote early satiety. These efforts will limit overall caloric intake thereby promoting weight loss. It is thought that patients with previous SG may have a dilation of their stomach. The investigators propose a pyloric cerclage using the Apollo EndoSurgery suturing device by decreasing the opening of the pylorus thus achieving the same goals that the investigators proposed above with RYGB revision. Endoscopic procedures are same day procedures with little morbidity and mortality when compared to laparoscopic or open bariatric surgery revision.


By | 2018-01-15T22:31:33+00:00 July 26th, 2015|Healthcare Informations|0 Comments

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