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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Chinese University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGChange in GERD symptoms
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score \[0-75, higher scores mean worse outcome\]
Time frame: 3 and 6months
Change in GERD symptoms
astroesophageal Reflux Disease Questionnaire (GERDQ) score \[0-18, higher scores mean worse outcome\]
Time frame: 3 and 6months
Technical success rate
defined as successful completion of endoscopic procedure
Time frame: 1 day
Change in DeMeester score and AET
evaluated by 24-hour pH monitoring
Time frame: 3 months
Dysphagia symptoms
evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score \[0-40, higher score mean worse outcome\]
Time frame: 3 and 6 months
PPI use
dosage of PPI use after procedure
Time frame: 3 and 6 months
Changes in cardia morphology
endoscopic assessment of Hill's flap grade
Time frame: 3 months
Adverse events rate relating to endoscopic intervention
complication including bleeding, perforation and stricture
Time frame: 7 days, 1, 3 and 6 months
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