Safety and Efficacy of Endoscopic Cardial Constriction Ligation （ECCL） With a Novel Disposable Endoscope: A Multicenter Randomized Controlled Trial

Gastroesophageal reflux disease (GERD) is a common digestive disorder, with endoscopic manifestations including non-erosive reflux disease (NERD), reflux esophagitis (RE), and Barrett's esophagus (BE). Typical symptoms include heartburn and regurgitation, while atypical symptoms encompass chest pain, epigastric pain, belching, and extraesophageal symptoms. Epidemiological surveys in China indicate a prevalence of heartburn occurring at least once weekly ranging from 1.9% to 7.0%. Chronic, recurrent GERD significantly impairs patients' quality of life and may increase the risk of Barrett's esophagus, esophageal mucosal dysplasia, and esophageal adenocarcinoma. The etiology of GERD is complex, involving increased esophageal acid exposure, lower esophageal sphincter (LES) relaxation, low esophagogastric junction (EGJ) pressure, impaired esophageal clearance, hiatal hernia, and damage to the mucosal barrier by cytokines (e.g., IL-6, IL-8, platelet-activating factor PAF) and other factors.

Currently, the first-line treatment for GERD includes lifestyle modifications and oral acid-suppressive medications, such as proton pump inhibitors (PPIs) and potassium-competitive acid blockers (P-CABs). However, some patients with refractory GERD require long-term acid-suppressive therapy, and prolonged PPI use may increase the risk of Clostridioides difficile infection, community-acquired pneumonia, gastric cancer, and chronic kidney disease, while short-term P-CAB use may lead to hypergastrinemia [13]. According to the 2020 Chinese GERD Expert Consensus, for patients with refractory GERD who fail medical therapy, endoscopic or surgical treatment may be considered after excluding other causes and confirming evidence of reflux.

Traditional endoscopes are reusable and require cleaning and disinfection after each use, but complete sterilization may not always be achieved, posing a risk of cross-infection. In contrast, disposable endoscopes eliminate the risk of cross-infection, bypass the need for cleaning and disinfection, and reduce the incidence of instrument-related infections, while offering comparable functionality and operability to traditional endoscopes. Endoscopic cardia constriction ligation (ECCL) is an emerging endoscopic treatment technique, first performed by Professor Linghu Enqiang in 2013. This procedure involves ligating and fixing the mucosa and partial muscle layer above the dentate line under direct endoscopic visualization, creating mucosal folds. Post-procedure, the ligated mucosa undergoes ischemic necrosis and heals to form scar tissue, reducing the cardia diameter, increasing LES pressure, and alleviating reflux symptoms. ECCL is characterized by simple operation and minimal invasiveness, making it safer than traditional surgical procedures. Related complications, such as bleeding after ligation band detachment and retrosternal pain, are infrequent, resolve quickly, and no severe adverse events have been reported to date. However, the long-term efficacy of ECCL requires further validation.

Currently, there are no studies on the efficacy and safety of ECCL performed using disposable endoscopes. This study aims to conduct a randomized controlled trial to compare the effectiveness, safety, flexibility, and imaging clarity of ECCL performed with disposable versus traditional endoscopes in treating refractory GERD, providing scientific evidence to optimize treatment strategies and inform future GERD treatment guidelines.

Participants in this study will be randomly assigned to either the disposable endoscope group or the traditional endoscope group to undergo ECCL treatment. The primary objective is to compare the efficacy of ECCL performed with disposable versus traditional endoscopes in treating refractory GERD. Secondary objectives include: 1) Evaluating the observation clarity, flexibility, and compatibility of disposable endoscopes with surgical consumables; 2) Assessing the incidence of device failures and complications related to disposable endoscope-guided ECCL, such as mucosal injury, bleeding, and perforation.