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

Qualifiers

(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

Treatments tested in this trial

  • endoscopic cardia constriction ligation

Treatment groups

46 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ying Zhu

Lead sponsor

Shenzhen Hospital of Southern Medical University

Sponsor institution