Endoscopic Sleeve Gastroplasty for Morbid Obesity

Prospective Randomized Trial Comparing Endoscopic Sleeve Gastroplasty Versus Conventional Laparoscopic Sleeve Gastrectomy in Patients With Morbid Obesity: From Physical and Functional Outcomes to Changes in Hormonal Profiles

Obesity and its related metabolic disorders are increasingly a heavy health burden to many parts of the world. Weight control is a well-known important step in avoiding type 2 diabetes mellitus (T2DM). It is also an essential component for normalizing the blood glucose and preventing macrovascular and microvascular insults to patients with diagnosed T2DM. However, life-style modification, physical exercise and dietary adjustment are ineffective measures which are unlikely to confer adequate and sustainable weight loss for the truly obese. On the other hand, large scale long-term follow-up studies have confirmed the role of bariatric surgery in providing durable weight loss and remarkable improvement on medical comorbidities. Among all the bariatric operations, laparoscopic sleeve gastrectomy (LSG) is currently the most widely adopted procedure worldwide because of its simplicity and effectiveness in weight reduction. However, LSG is not without risk. Staple-line hemorrhage, leakage and stenosis are potentially life-threatening complications. LSG is also costly because of the need for expensive laparoscopic staplers.

Study Overview

• Status: Unknown
• Conditions: Endoscopic Sleeve Gastroplasty
• Intervention / Treatment: Procedure: Endoscopic Sleeve Gastroplasty; Procedure: Laparoscopic Sleeve Gastrectomy

Detailed Description

A new endoscopic bariatric therapy, namely endoscopic sleeve gastroplasty (ESG), has recently been proposed as a non-surgical procedure for the management of obesity with or without diabetes mellitus. Preliminary data based on single arm series or phase II studies have reported promising short and intermediate term weight control effect.

However, whether ESG is a feasible option comparable to LSG in the intermediate term remains an unanswered question. In addition, physical and functional outcomes after ESG were not well documented in most of the reported series.

Realizing there is a knowledge gap in applying ESG to patients with morbid obesity, we propose to study and compare the efficacy of weight control and functional outcomes of ESG against conventional LSG. Through this prospective randomized trial, the safety profiles, quality of life and changes in fasting and post-prandial gut hormone secretion after the two procedures will also be assessed and compared. The evidence thus generated shall lay a scientific foundation for ESG which may become an alternative choice for patients who have concerns about complication and irreversibility of most bariatric surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A BMI > 35 kg/m2
2. A BMI > 30 kg/m2 with T2DM
3. A BMI>3 30kg/m2 with 2 or more co-morbidities

Exclusion Criteria:

1. Significant anaesthetic risk (> ASA III)
2. History of diabetic ketoacidosis or hyperosmolar coma
3. Uncontrolled T2 DM with HbA1c > 12%
4. A BMI > 45 kg/m2
5. Malignancy diagnosed within 5 years
6. Endoscopic findings of any pre-neoplastic/neoplastic lesions, portal hypertensive gastropathy or significant varices
7. Chronic renal failure requiring dialysis
8. Previous upper abdominal surgery (including bariatric surgery) affecting gastroduodenal configuration
9. Major psychiatric illness including major depression and substance abuse
10. Pregnancy or ongoing breast-feeding
11. Inmates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic Sleeve Gastroplasty; A series of full thickness sutures done with Overstitch in the triangular stitch pattern as mentioned by Lopez-Nava[29] will be placed according to the APC markings. The suturing is initiated from the antrum distally and moved proximally towards the gastric fundus. A total of 6 to 8 plications are placed to reduce the gastric lumen. Five sham dressings would also be applied to patient's abdominal wall during the first week to minimize the bias in pain scoring.	Procedure: Endoscopic Sleeve Gastroplasty; An oesophageal overtube is then inserted to facilitate passage of the endoscope mounted with Overstitch device. A series of full thickness sutures done with Overstitch in the triangular stitch pattern as mentioned by Lopez-Nava[29] will be placed according to the APC markings. The suturing is initiated from the antrum distally and moved proximally towards the gastric fundus. A total of 6 to 8 plications are placed to reduce the gastric lumen. Five sham dressings would also be applied to patient's abdominal wall during the first week to minimize the bias in pain scoring.
Active Comparator: Laparoscopic Sleeve Gastrectomy; Sleeve gastrectomy is then performed using lapaorscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up to the angle of His along the left side of the Mid-sleeve tube. Haemostasis of the staple line is secured by suture plication with the Mid-sleeve tube in situ to ensure no compromise of the gastric tube lumen. All the wounds are closed with staples after local anaesthetic infiltration and covered with non-transparent dressings.	Procedure: Laparoscopic Sleeve Gastrectomy; Sleeve gastrectomy is then performed using lapaorscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up to the angle of His along the left side of the Mid-sleeve tube. Haemostasis of the staple line is secured by suture plication with the Mid-sleeve tube in situ to ensure no compromise of the gastric tube lumen. All the wounds are closed with staples after local anaesthetic infiltration and covered with non-transparent dressings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of excess weight loss	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time		during operation
total blood loss intra-operation	total blood loss will be recorded in operation record	during operation
early postoperative pain scores		7 days
perioperative complications	mortality	30 days
postoperative hospital stay		30 days
Percentages of excess weight loss	(%EWL)	1 year
total weight loss	(%TWL)	1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: CRE2017.127-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No