Endoscopic Sleeve Gastroplasty for Morbid Obesity

NCT03124485 | Unknown DMC

• 1 other identifier: CRE2017.127-T
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endoscopic Sleeve Gastroplasty

Outcome Measures

Primary Outcomes (1)

• Percentage of excess weight loss

  1 year

Secondary Outcomes (7)

• operative time

  during operation

• total blood loss intra-operation

  during operation

• early postoperative pain scores

  7 days

• perioperative complications

  30 days

• postoperative hospital stay

  30 days

Study Arms (2)

Endoscopic Sleeve Gastroplasty

EXPERIMENTAL

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

Laparoscopic Sleeve Gastrectomy

ACTIVE COMPARATOR

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

Interventions

Endoscopic Sleeve Gastroplasty PROCEDURE

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.

Endoscopic Sleeve Gastroplasty

Laparoscopic Sleeve Gastrectomy PROCEDURE

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.

Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, China

Location

Central Study Contacts

Candice Lam

CONTACT

35052956; candicelam@surgery.cuhk.edu.hk

Jenny Ho

CONTACT

35052956; jennyho@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study protocol aims to test the hypothesis that endoscopic sleeve gastroplasty (ESG) IS NOT inferior to conventional laparoscopic surgical sleeve gastrectomy (LSG) in terms of weight loss and improvement of glycemic control for Asian obese patients. It also investigates and compares the safety profile, improvement of co-morbidities, functional outcomes and changes in gut hormone profiles between the two bariatric procedures.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 21, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

CN (1)