ARMA for Postoperative GERD After Sleeve Gastrectomy

Not Applicable

• Conditions: Gastroesophageal Reflux
• Interventions: Procedure: Anti-reflux mucosal ablation

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-reflux mucosal ablation	Anti-reflux mucosal ablation	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

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