Clinical trial NCT03124485: Endoscopic Sleeve Gastroplasty for Morbid Obesity
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Sleeve Gastroplasty
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of excess weight loss
timeFrame: 1 year
Secondary outcomes:
measure: operative time
timeFrame: during operation
measure: total blood loss intra-operation
timeFrame: during operation
measure: early postoperative pain scores
timeFrame: 7 days
measure: perioperative complications
timeFrame: 30 days
measure: postoperative hospital stay
timeFrame: 30 days
measure: Percentages of excess weight loss
timeFrame: 1 year
measure: total weight loss
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
Study officials:
References: