Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Gastro Esophageal Reflux

Treatments: Procedure: Antireflux Mucosectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04194723

CREC 2016.194T

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Antireflux Mucosectomy

Experimental group

Description:

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

Treatment:

Procedure: Antireflux Mucosectomy