ARMA for Postoperative GERD After Sleeve Gastrectomy

Gastroesophageal Reflux Clinical Trial

Official title:

Anti-reflux Mucosal Ablation (ARMA) for the Treatment of Postoperative Gastroesophageal Reflux After Sleeve Gastrectomy - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259579
• Other study ID #: CRE-2021.553
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2022
• Source: Chinese University of Hong Kong
• Contact: Stephen Ng, FRCSEd(Gen)
• Phone: +85235052956
• Email: stephenng[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Procedure:
• Anti-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.

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in GERD symptoms	Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score [0-75, higher scores mean worse outcome]	3 and 6months
Primary	Change in GERD symptoms	astroesophageal Reflux Disease Questionnaire (GERDQ) score [0-18, higher scores mean worse outcome]	3 and 6months
Secondary	Technical success rate	defined as successful completion of endoscopic procedure	1 day
Secondary	Change in DeMeester score and AET	evaluated by 24-hour pH monitoring	3 months
Secondary	Dysphagia symptoms	evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score [0-40, higher score mean worse outcome]	3 and 6 months
Secondary	PPI use	dosage of PPI use after procedure	3 and 6 months
Secondary	Changes in cardia morphology	endoscopic assessment of Hill's flap grade	3 months
Secondary	Adverse events rate relating to endoscopic intervention	complication including bleeding, perforation and stricture	7 days, 1, 3 and 6 months