Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

Launched by CHINESE UNIVERSITY OF HONG KONG · Dec 10, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called endoscopic antireflux mucosectomy (ARMS) to treat gastroesophageal reflux disease (GERD), a condition where stomach acid frequently flows back into the esophagus, causing discomfort. The trial aims to see if this procedure is safe and effective for patients who have been experiencing GERD symptoms and have not found relief with medications known as proton pump inhibitors (PPIs) for at least three months.

To participate in the trial, patients should be between the ages of 65 and 70, or between 25 and 65, and have typical GERD symptoms that respond to PPI therapy. Eligible participants will need to meet certain medical criteria, such as having specific issues at the gastroesophageal junction and evidence of acid-related problems in their esophagus. If you join the trial, you can expect close monitoring and care as researchers evaluate the effects of the ARMS procedure. Importantly, individuals over 70, under 18, pregnant, or with certain medical conditions will not be eligible to participate. This study is currently recruiting participants, so if you meet the criteria and are interested, it could be a chance to explore a new treatment option for GERD.

Gender

ALL

Eligibility criteria

• 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