Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

Not Applicable

Recruiting

• Conditions: Gastro Esophageal Reflux
• Interventions: Procedure: Antireflux Mucosectomy

• Registration Number: NCT04194723
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.

Detailed Description

The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
2. Hill's grade II and III of the gastroesophageal junction
3. One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH < 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of < 6mmHg or total length of less than 4cm or abdominal length of less than 2cm

Exclusion Criteria

1. Age > 70 yrs of < 18 yrs
2. Pregnancy
3. Any type of Hiatus hernia
4. Patients with underlying malignancy
5. ASA above grade III

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antireflux Mucosectomy	Antireflux Mucosectomy	Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction

Primary Outcome Measures

Name	Time	Method
Improvement in Gastro Esophageal Reflux symptoms	3 months	GERD symptoms evidence by the improvement in the Gastroesophageal Reflux Quality of Life (QoL) of ≥50% compared to the baseline off Proton Pump Inhibitors (PPI) value 3 months after the procedure

Secondary Outcome Measures

Name	Time	Method
24 hour pH study post ARMS	3 and 12 months	24 hour pH study
High resolution Manometry	3 and 12 months	HRM
Technical Success	1 day	Success in resection of mucosa at cardia by ARMS
Gastroesophageal junction classified by Hill's classification	3 and 12 months	endoscopic assessment of Gastroesophageal junction

Trial Locations

Locations (1)

Combined Endoscopy Center, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong