BEAM for Weight Loss - a Pilot Study

Not Applicable

Recruiting

Brief Summary: Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies.

Recruitment & Eligibility

Inclusion Criteria

BMI equal or more than 30kg/m2 (27.5kg/m2 for Chinese or South Asian) to 40kg/m2, or BMI equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, AND
failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination

Exclusion Criteria

Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
Gastroparesis
Active smoking
An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
Previous pyloromyotomy or pyloroplasty
Gastrointestinal obstruction
Use of any medication that may interfere with weight loss or gastric emptying
Severe coagulopathy
Esophageal or gastric varices and/or portal hypertensive gastropathy
Underlying uncontrolled endocrine problem that leads to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc.)
Any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)
Malignancy
Pregnant or breast feeding
Patients not fit for general anesthesia
ASA grade IV or V
Mental or psychiatric disorder; Drug or alcohol addiction
Other cases deemed by the examining physician as unsuitable for safe treatment
Refusal to participate

Arm && Interventions

Group	Intervention	Description
Bariatric endoscopic antral myotomy	Bariatric endoscopic antral myotomy	Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety.

Primary Outcome Measures

Name	Time	Method
Body weight	baseline, 1,3,6,12 months	Weight change compared to baseline
Adverse events	within 30 days of procedure	Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)

Secondary Outcome Measures

Name	Time	Method
Technical success rate	1 day	successful completion of endoscopic procedures
Serum ghrelin levels	baseline, 1,3,6,12 months	Serum ghrelin levels compared to baseline
Blood pressure	baseline, 1,3,6,12 months	Blood pressure and anti-hypertensive medication use compared to baseline
Lipid profile	baseline, 1,3,6,12 months	Lipid profile compared to baseline
Gastric emptying symptoms	baseline, 1,6,12 months	measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)
Fasting glucose level	baseline, 1,3,6,12 months	levels compared to baseline
Pain scale after procedure	3 days	measured by visual analogue scale (0:no pain - 10:worst pain)
Change in Quality of Life	baseline, 1,6,12 months	measured by 36-Item Short Form Survey (SF-36) questionnaire - (0:worst - 100:best)
Insulin level	baseline, 1,3,6,12 months	levels compared to baseline
HbA1c level	baseline, 1,3,6,12 months	levels compared to baseline
serum liver parameters	baseline, 1,3,6,12 months	AST, ALT, ALP and GGT level compared to baseline
hepatic steatosis index	baseline, 1,3,6,12 months	level compared to baseline
NAFLD fibrosis	baseline, 1,3,6,12 months	NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)
obstructive sleep apnea	baseline, 1,3,6,12 months	Change in sleep quality