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

Endoscopic Sleeve Gastroplasty for Morbid Obesity



Sponsors


Source

Chinese University of Hong Kong

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2017-08-01

Completion Date

2020-09-01

Primary Completion Date

2020-08-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Percentage of excess weight loss
1 year

Secondary Outcome

Measure

Time Frame

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
Percentages of excess weight loss
1 year
total weight loss
1 year

Enrollment

37

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

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.

Arm Group Label

Endoscopic Sleeve Gastroplasty


Intervention Type

Procedure

Intervention Name


Description

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.

Arm Group Label

Laparoscopic Sleeve Gastrectomy



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

Gender

All

Minimum Age

18 Years

Maximum Age

65 Years

Healthy Volunteers

No


Overall Contact

Last Name

Candice Lam

Phone

35052956

Email



Location

Facility

Chinese University of Hong Kong
Hong Kong China

Location Countries

Country

China


Verification Date

2017-04-01

Lastchanged Date

2017-04-19

Firstreceived Date

2017-04-19

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Chinese University of Hong Kong

Investigator Full Name

Enders K.W. Ng

Investigator Title

Professor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Endoscopic Sleeve Gastroplasty

Arm Group Type

Experimental

Description

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.


Arm Group Label

Laparoscopic Sleeve Gastrectomy

Arm Group Type

Active Comparator

Description

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.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Jenny Ho

Phone

35052956

Email



Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Crossover Assignment

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

Masking

No masking



ClinicalTrials.gov processed this data on April 21, 2017

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Interventions

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Study Phase

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In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

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