ARMA for Postoperative GERD After Sleeve Gastrectomy

The Chinese University of Hong Kong

Status: Unknown

Conditions: Gastroesophageal Reflux

Treatments: Procedure: Anti-reflux mucosal ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05259579

CRE-2021.553

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Anti-reflux mucosal ablation

Experimental group

Description:

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

Treatment:

Procedure: Anti-reflux mucosal ablation