Endoscopic Cardial Constriction Ligation (ECCL) for Refractory GERD Using a Disposable Endoscope
NCT07176221 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2025-09-16
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.
Conditions
- Gastroesophageal Reflux Disease (GERD)
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.
Sponsors & Collaborators
-
Ying Zhu
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
Countries
- China
Study Locations
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