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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Chinese University of Hong Kong
Shatin, Hong Kong
RECRUITINGBody weight
Weight change compared to baseline
Time frame: 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)
Time frame: within 30 days of procedure
Technical success rate
successful completion of endoscopic procedures
Time frame: 1 day
Serum ghrelin levels
Serum ghrelin levels compared to baseline
Time frame: baseline, 1,3,6,12 months
Blood pressure
Blood pressure and anti-hypertensive medication use compared to baseline
Time frame: baseline, 1,3,6,12 months
Lipid profile
Lipid profile compared to baseline
Time frame: baseline, 1,3,6,12 months
Pain scale after procedure
measured by visual analogue scale (0:no pain - 10:worst pain)
Time frame: 3 days
Change in Quality of Life
measured by 36-Item Short Form Survey (SF-36) questionnaire - (0:worst - 100:best)
Time frame: baseline, 1,6,12 months
Gastric emptying symptoms
measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)
Time frame: baseline, 1,6,12 months
Fasting glucose level
levels compared to baseline
Time frame: baseline, 1,3,6,12 months
Insulin level
levels compared to baseline
Time frame: baseline, 1,3,6,12 months
HbA1c level
levels compared to baseline
Time frame: baseline, 1,3,6,12 months
serum liver parameters
AST, ALT, ALP and GGT level compared to baseline
Time frame: baseline, 1,3,6,12 months
hepatic steatosis index
level compared to baseline
Time frame: baseline, 1,3,6,12 months
NAFLD fibrosis
NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)
Time frame: baseline, 1,3,6,12 months
obstructive sleep apnea
Change in sleep quality
Time frame: baseline, 1,3,6,12 months
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