Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric endoscopic antral myotomy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric endoscopic antral myotomy | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | successful completion of endoscopic procedures | 1 day |
| Serum ghrelin levels | Serum ghrelin levels compared to baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Ng, FRCSEd(Gen) | Contact | +85235052956 | stephenng@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Ng, FRCSEd(Gen) | Prince of Wales Hospital, the Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Recruiting | Shatin | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |