Status:
UNKNOWN
Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
Shandong University
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Endoscopic full-thickness plication (EFTP) of cardia/fundus has been shown effective in treating GERD patients. However, EFTP requires proprietary equipment that are not available in many countries. H...
Detailed Description
Endoscopic full thickness pancreatography (EFTP) is a minimally invasive surgical method that has emerged in recent years for the treatment of severe gastroesophageal reflux disease. This surgery requ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06153901
Start Date
December 10 2023
End Date
December 10 2024
Last Update
December 1 2023
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