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

NCT07176221 | Not Yet Recruiting

• 1 other identifier: NYSZYYEC2025K055R002
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Gastroesophageal Reflux Disease (GERD).; Endoscopic cardia constriction ligation (ECCL); novel disposable endoscope

Outcome Measures

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.

  From baseline before the procedure to 6 months post-procedure

Secondary Outcomes (10)

• Rate of Clinical Feasibility of ECCL Treatment Using Disposable Endoscopes

  From baseline before the procedure to 6 months post-procedure

• Device Failure/Defect Rate

  From baseline before the procedure to 6 months post-procedure

• Number of Participants with Endoscope-Related Mucosal Injury

  From baseline before the procedure to 1 hour post-procedure

• Number of Participants with Gastrointestinal Perforation

  From baseline before the procedure to 1 hour post-procedure

• Number of Participants with Significant Bleeding

  From baseline before the procedure to 1 hour post-procedure

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will undergo endoscopic cardia constriction ligation (ECCL) using disposable endoscopes. The procedure involves: under direct visualization, sequentially suctioning and ligating one ring each on the lesser curvature, posterior wall, and greater curvature of the cardia, capturing the mucosal and muscular layers. A hemostatic clip will be used to secure the base of the ligated tissue on the greater curvature. Six hours post-procedure, patients may consume lukewarm liquid or semi-liquid diets and continue acid-suppressive therapy for two weeks. Vital signs and any procedure-related serious adverse events will be recorded for statistical analysis.

Procedure: endoscopic cardia constriction ligation

Control Group

ACTIVE COMPARATOR

The control group will undergo endoscopic cardia constriction ligation (ECCL) using traditional endoscopes. The procedure involves: under direct visualization, sequentially suctioning and ligating one ring each on the lesser curvature, posterior wall, and greater curvature of the cardia, capturing the mucosal and muscular layers. A hemostatic clip will be used to secure the base of the ligated tissue on the greater curvature. Six hours post-procedure, patients may consume lukewarm liquid or semi-liquid diets and continue acid-suppressive therapy for two weeks. Vital signs and any procedure-related serious adverse events will be recorded for statistical analysis.

Procedure: endoscopic cardia constriction ligation

Interventions

endoscopic cardia constriction ligation PROCEDURE

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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;
• (5) Patients with coagulation disorders, severe cardiopulmonary diseases, or inability to tolerate anesthesia, endoscopy, or treatment;
• (6) Women in the puerperium.

Sponsors & Collaborators

• Ying Zhu: lead

Study Sites (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Ying Zhu

CONTACT

+86-13384662039; zhuying1@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)