Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Nov 22, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new procedure called endoloop mediated cardioplication (ECLC) to treat gastroesophageal reflux disease (GERD). GERD is a condition where stomach acid frequently flows back into the esophagus, causing symptoms like heartburn and discomfort. The trial aims to find out if this new method, which uses a special metal clip, can effectively help patients with GERD, especially in places where the current treatment options are not available.

To participate in this trial, you need to be between 18 and 60 years old and have had classic reflux symptoms for more than six months. You should also have a specific type of hernia that is not too large and have been taking daily medications called proton pump inhibitors (PPIs) for at least six months. Participants will undergo the new procedure and be monitored for its effects. It's important to note that some people may not qualify, such as those with certain health conditions or a history of specific surgeries. If you're interested, the trial will require you to sign a consent form and agree to cover any surgical costs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-60 years old
• • hiatal hernia ≤ 3cm
• • Sliding hernia ≤ 3cm
• • Classic reflux symptoms (heartburn, reflux) lasting for more than 6 months
• • Daily PPIs ≥ 6 months
• • Esophagitis (Los Angeles grade) Grade A, B, and C
• • Gastroesophageal valve I-III grade (Hill grade)
• • Pathological esophageal acid exposure (percentage of time with 24-hour esophageal PH\<4 \<4.2%)
• • Normal or near normal esophageal movement (through manometry or impedance)
• • The lower esophageal sphincter pressure (LESP) is between 5-15mmHg
• • DeMeester score ≥ 14.7 or total reflux episodes\>73
• • Patients who sign an informed consent form and voluntarily accept surgical expenses.
• Exclusion Criteria:
• • BMI\>35kg/m2
• • ASA \>II
• • Barrett's esophagus
• • Hill IV level
• • Large esophageal hiatal hernia\>3cm
• • Esophagitis (Los Angeles grade) Grade D
• • Peptic ulcer
• • Primary esophageal motility disorders such as achalasia
• • Previous esophageal or gastric surgery
• • Uncontrolled systemic diseases
• • Pregnancy or planned pregnancy within 1 year
• • Have a history of cervical fusion surgery, esophageal diverticulum, scleroderma or dermatomyositis, eosinophilic esophagitis, liver cirrhosis or coagulation dysfunction, immune system diseases
• • Patients deemed unsuitable for inclusion by researchers.