Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux

NCT04194723 | Unknown

• 1 other identifier: CREC 2016.194T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastro Esophageal Reflux

Keywords

Antireflux Mucosectomy; GERD

Outcome Measures

Primary Outcomes (1)

• Improvement in Gastro Esophageal Reflux symptoms

  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

  3 months

Secondary Outcomes (4)

• Technical Success

  1 day

• 24 hour pH study post ARMS

  3 and 12 months

• High resolution Manometry

  3 and 12 months

• Gastroesophageal junction classified by Hill's classification

  3 and 12 months

Study Arms (1)

Antireflux Mucosectomy

EXPERIMENTAL

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

Procedure: Antireflux Mucosectomy

Interventions

Antireflux Mucosectomy PROCEDURE

ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux

Antireflux Mucosectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
• Hill's grade II and III of the gastroesophageal junction
• 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

You may not qualify if:

• Age \> 70 yrs of \< 18 yrs
• Pregnancy
• Any type of Hiatus hernia
• Patients with underlying malignancy
• ASA above grade III

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, 00000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Philip Wai Yan Chiu, MD, FRCSEd

CONTACT

+85235053952; philipchiu@surgery.cuhk.edu.hk

Man Yee Yung

CONTACT

+85235052956; myyung@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 11, 2019
• Study Start: January 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

HK (1)