Endoscopic Sleeve Gastroplasty for Morbid Obesity

NCT ID: NCT03124485

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2020-09-30

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.

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.

Conditions

Endoscopic Sleeve Gastroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Endoscopic Sleeve Gastroplasty

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Laparoscopic Sleeve Gastrectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Enders K.W. Ng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese University of Hong Kong

Hong Kong, , China

Countries

China

Central Contacts

Candice Lam

Role: CONTACT

candicelam@surgery.cuhk.edu.hk

35052956

Jenny Ho

Role: CONTACT

jennyho@surgery.cuhk.edu.hk

35052956

Other Identifiers

CRE2017.127-T

Identifier Type: -

Identifier Source: org_study_id