Endoscopic Sleeve Gastroplasty for Morbid Obesity

Endoscopic Sleeve Gastroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03124485
• Other study ID #: CRE2017.127-T
• Status: Not yet recruiting
• Phase: N/A
• First received: April 19, 2017
• Last updated: April 19, 2017
• Start date: August 2017
• Est. completion date: September 2020

Study information

• Verified date: April 2017
• Source: Chinese University of Hong Kong
• Contact: Candice Lam
• Phone: 35052956
• Email: candicelam[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Sleeve Gastroplasty
• Obesity, Morbid

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

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