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This study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-reflux mucosal ablation | Experimental | This technique creates an anti-reflux mechanism by performing mucosal ablation at the gastric cardia and inducing cicatrisation, and thereby rebuilds the flap valve at the gastric cardia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-reflux mucosal ablation | Procedure | Mucosal ablation is planned around the cardia on the gastric side in a butterfly shape. Submucosal layer is raised by injecting saline with indigo carmine dye. Mucosal ablation is performed using the triangle-tip knife in spray coagulation mode. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GERD symptoms | Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score [0-75, higher scores mean worse outcome] | 3 and 6months |
| Change in GERD symptoms | astroesophageal Reflux Disease Questionnaire (GERDQ) score [0-18, higher scores mean worse outcome] | 3 and 6months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | defined as successful completion of endoscopic procedure | 1 day |
| Change in DeMeester score and AET | evaluated by 24-hour pH monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Ng, FRCSEd(Gen) | Contact | +85235052956 | stephenng@surgery.cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
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| 3 months |
| Dysphagia symptoms | evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score [0-40, higher score mean worse outcome] | 3 and 6 months |
| PPI use | dosage of PPI use after procedure | 3 and 6 months |
| Changes in cardia morphology | endoscopic assessment of Hill's flap grade | 3 months |
| Adverse events rate relating to endoscopic intervention | complication including bleeding, perforation and stricture | 7 days, 1, 3 and 6 months |
| D004066 | Digestive System Diseases |