Endoscopic Cardial Constriction Ligation (ECCL) for Refractory GERD Using a Disposable Endoscope
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYing Zhu
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(1) Age 18-80 years;
(2) Disease duration ≥6 months, with typical symptoms such as acid regurgitation and heartburn, and a confirmed diagnosis of GERD;
(3) GERD patients whose symptoms are not relieved after 8 weeks of continuous double-dose acid-suppressive therapy;
(4) Willing to participate in the study and have signed the informed consent form.
Disqualifiers
(1) Patients with precancerous lesions such as early esophageal cancer or Barrett's esophagus >3 cm, or advanced upper gastrointestinal cancer identified on endoscopy;
(2) Patients with hiatal hernia ≥2 cm, severe reflux esophagitis (LA-C or LA-D grade), esophageal or gastric varices, esophageal ulcer or stenosis, or a history of esophageal or gastric surgery;
(3) Patients with esophageal motility disorders such as achalasia or diffuse esophageal spasm, rheumatic diseases such as systemic sclerosis or Sjögren's syndrome, or eosinophilic esophagitis;
(4) Patients with a history of endoscopic or surgical anti-reflux procedures;
Trial design
Design model
Parallel
Treatments tested in this trial
endoscopic cardia constriction ligation
Procedure/SurgeryThe 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in GERD-Q Score
Change in GERD-Q score (a validated questionnaire assessing GERD-related symptoms such as acid regurgitation and heartburn) from baseline, measured in patients undergoing ECCL with disposable endoscopes versus traditional endoscopes. GERD-Q scores are collected at baseline (pre-procedure via questionnaire and endoscopic examination), 3 months post-procedure, and 6 months post-procedure during follow-up visits.
Time frame
From baseline before the procedure to 6 months post-procedureSecondary outcomes
1
Rate of Clinical Feasibility of ECCL Treatment Using Disposable Endoscopes
After passing through the cardia, the endoscope can be successfully inverted to observe the cardia, clearly visualizing the dentate line. During endoscopic cardia constriction ligation (ECCL), the ligation device can be securely attached to the endoscope, effectively suctioning the gastric wall mucosa and smoothly releasing the ligation ring. Additionally, all abnormal findings mentioned in the gastroscopy report should be photographed and documented. If the entire gastroscopy examination and treatment are completed, it is considered feasible. If the examination or treatment is interrupted due to issues with the endoscope itself, it is considered infeasible. Calculation Formula: Clinical feasibility rate = (Number of participants completing the procedure successfully ÷ Total number of participants) × 100%Clinical feasibility rate of disposable endoscope ECCL treatment = (Number of participants completing the procedure successfully ÷ Total number of participants) × 100%.
Time frame
From baseline before the procedure to 6 months post-procedure2
Device Failure/Defect Rate
Observe whether the device experiences any malfunctions during the procedure, such as image interruption, blockage, or leakage during water delivery.
Time frame
From baseline before the procedure to 6 months post-procedure3
Number of Participants with Endoscope-Related Mucosal Injury
Document any occurrences of mucosal injury directly related to the use of disposable endoscopes during the ECCL procedure.
Time frame
From baseline before the procedure to 1 hour post-procedure4
Number of Participants with Gastrointestinal Perforation
Record any cases of gastrointestinal perforation occurring during or within 1 hour after the ECCL procedure using disposable endoscopes.
Time frame
From baseline before the procedure to 1 hour post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ying Zhu
Lead sponsor
Shenzhen Hospital of Southern Medical University
Sponsor institution
Source ClinicalTrials.gov
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