ARMA for Postoperative GERD After Sleeve Gastrectomy

Not Applicable

• Conditions: Gastroesophageal Reflux

• Registration Number: NCT05259579
• Lead Sponsor: Chinese University of Hong Kong

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-26
• Status Verified: 2022-02
• Study Start: 2022-02-01
• Study First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Primary Completion: 2023-01-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in GERD symptoms	3 and 6months	astroesophageal Reflux Disease Questionnaire (GERDQ) score \[0-18, higher scores mean worse outcome\]

Secondary Outcome Measures

Name	Time	Method
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
Dysphagia symptoms	3 and 6 months	evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score \[0-40, higher score mean worse outcome\]
Adverse events rate relating to endoscopic intervention	7 days, 1, 3 and 6 months	complication including bleeding, perforation and stricture
Change in DeMeester score and AET	3 months	evaluated by 24-hour pH monitoring
PPI use	3 and 6 months	dosage of PPI use after procedure

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong