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Endoscopic Cardial Constriction Ligation (ECCL) for Refractory GERD Using a Disposable Endoscope
Sponsor: Ying Zhu
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
Conditions
Interventions
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