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Anti-reflux Mucosal Ablation Therapy Randomized Sham Control Trial for Gastroesophageal Reflux Disease

NCT06106100 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-02-23

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to investigate the efficacy and safety of antireflux mucosal ablation (ARMA) for patients with refractory gastroesophageal reflux disease (GERD). The trial aim to evaluate :

* Efficacy of ARMA comparing with medical treatment alone (proton pump inhibitor (PPI)), using GERD-Health Related Quality of Life Questionnaire (GERD- HRQL questionnaire), improvement of acid exposure time and DeMeester score
* Safety and complications of ARMA Participants will be randomly divided into 2 groups. The intervention group will be undergone ARMA, and the control group will be undergone sham endoscopic treatment.

The primary endpoint will be symptoms relief (GERD-HRQL decreases \> 50%). The secondary endpoint will be dosage adjustment of PPI, complications, improvement of acid exposure time and DeMeester score.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

PROCEDURE

Antireflux mucosal ablation

Patients are instructed to fast for 6 hours pre-procedurally, which are performed under intravenous propofol sedation. Retroflexion endoscopy to visualize the cardia is performed, followed by mucosa markings with straight-fire APC catheter (ERBE Electromedizin, Tübingen, Germany) in forced coagulation mode (VIO300D, ERBE Electromedizin, Tübingen, Germany, 20W). The marking site at 1-cm and 2-cm distal to squamocolumnar junction at anterior-posterior and lesser curvature site, respectively, sparing the greater curvature site of cardia, is done. After marking, mucosal ablation (forced coagulation mode, 1L/min, 80W) is performed at marking site in a hoarse-shoe shape. Adequate ablation depth is defined as reaching the submucosal layer with blackish discolored tissue with carbonization

PROCEDURE

Sham procedure

Patients are instructed to fast for 6 hours pre-procedurally, which are performed under intravenous propofol sedation. Retroflexion endoscopy to visualize the cardia is performed. Using the straight-fire APC catheter to touch the marking sites similar to the treatment group without electrocauterization is performed.

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2026-10-31
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06106100 on ClinicalTrials.gov