BEAM for Weight Loss - a Pilot Study (BEAM pilot)

Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Procedure: Bariatric endoscopic antral myotomy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Ng, FRCSEd(Gen); Phone Number: +85235052956; Email: stephenng@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Chinese University of Hong Kong
    • Contact: Stephen Ng, FRCSEd(Gen); Phone Number: +85235052956; Email: stephenng@surgery.cuhk.edu.hk
    • Contact: Jenny Ho; Phone Number: +85235052956; Email: jennyho@surgery.cuhk.edu.hk
    • Contact: Stephen Ka Kei Ng, FRCSEd(Gen)
    • Contact: Philip Wai Yan Chiu, FRCSEd(Gen), MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: Bariatric endoscopic antral myotomy; A mucosal incision is performed using a triangle-tip knife J at the level of the incisura along the level of the greater curvature. Submucosal tunneling is then performed and stopped immediately proximal to the pylorus. Two parallel lines of partial thickness myotomy are then performed from the distal to proximal antrum using the same endoscopic knife. The myotomy is stopped approximately 2 cm distal to the mucosal incision site. Finally, the mucosal incision is closed using endoclips after haemostasis is confirmed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Stephen Ng, FRCSEd(Gen), Prince of Wales Hospital, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 21, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: CRE-2024.223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No