Gastroesophageal Reflux
Conditions
Brief summary
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
Interventions
PROCEDUREAnti-reflux mucosal ablation
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment * Pathological esophageal acid exposure, defined by DeMeester score \>14.7 or acid exposure time (AET) \>4.2% on pH study
Exclusion criteria
* Primary esophageal motility disorders * Sliding hiatal hernia \>3cm * Narrow gastric sleeve that precludes retroflexion of scope * Gastric sleeve stricture * Malignancy * Pregnancy * Patients not fit for general anesthesia * Other cases deemed by the examining physician as unsuitable for safe treatment * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in GERD symptoms | 3 and 6months | Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score \[0-75, higher scores mean worse outcome\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in DeMeester score and AET | 3 months | evaluated by 24-hour pH monitoring |
| Dysphagia symptoms | 3 and 6 months | evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score \[0-40, higher score mean worse outcome\] |
| Technical success rate | 1 day | defined as successful completion of endoscopic procedure |
| Changes in cardia morphology | 3 months | endoscopic assessment of Hill's flap grade |
| Adverse events rate relating to endoscopic intervention | 7 days, 1, 3 and 6 months | complication including bleeding, perforation and stricture |
| PPI use | 3 and 6 months | dosage of PPI use after procedure |
Countries
Hong Kong
Contacts
Primary ContactStephen Ng, FRCSEd(Gen)
Outcome results
None listed