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NOT YET RECRUITING
NCT07176221
NA

Endoscopic Cardial Constriction Ligation (ECCL) for Refractory GERD Using a Disposable Endoscope

Sponsor: Ying Zhu

View on ClinicalTrials.gov

Summary

This study will recruit patients aged 18-80 with refractory gastroesophageal reflux disease (GERD). These patients had a disease course of more than six months, experienced typical symptoms such as acid reflux and heartburn, and had no symptom relief after taking a double dose of acid-suppressing medication for eight consecutive weeks. All eligible participants will undergo Endoscopic Cardial Constriction Ligation (ECCL) using a disposable endoscope. The procedure will follow a standardized protocol: mucosal and muscle layers of the cardia will be ligated at the lesser curvature, posterior wall, and greater curvature, with the ligated tissue at the greater curvature secured by a hemostatic clip. All patients will receive acid-suppressing therapy post-surgery and will be followed up at three and six months. The follow-ups will assess their GERD-Q scores, symptom relief, and incidence of complications.

Official title: Safety and Efficacy of Endoscopic Cardial Constriction Ligation (ECCL) With a Novel Disposable Endoscope: A Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2025-10-01

Completion Date

2028-06-30

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

PROCEDURE

endoscopic cardia constriction ligation

The experimental group used disposable endoscopes to perform ECCL, while the control group used traditional endoscopes to perform ECCL. ECCL involves ligating and fixing the mucosa and partial muscle layer above the dentate line under direct endoscopic visualization to create folds. Post-procedure, the ligated mucosa undergoes ischemic necrosis and heals to form scar tissue, thereby reducing the cardia diameter, increasing LES pressure, and alleviating reflux symptoms.

Locations (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China