Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease

Shandong University

Status: Not yet enrolling

Conditions: Gastroesophageal Reflux Disease

Treatments: Procedure: endoloop mediated cardioplication (ECLC) procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06153901

2023-QILU-LU 02

Details and patient eligibility

About

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. Here, we designed a metal clip and endoloop mediated cardioplication (ECLC) procedure to achieve EFTP.

Full 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 requires the use of disposable patented instruments, which is expensive and has not entered the domestic market. To this end, we have innovatively developed an endoloop mediated cardioplication (ECLC) that only requires metal clips and nylon ropes. The most common and inexpensive endoscopic consumables can achieve the effect of tightening the lower esophageal sphincter, which is expected to be used for the treatment of gastroesophageal reflux disease. The ECLC surgery first incises the mucosa and submucosa on the small curvature side and posterior side (approximately 3/4 of the total circumference) of the diaphragm level cardia until smooth muscle fibers are exposed; Fix the metal clip covered with nylon rope on the exposed smooth muscle layer, and finally tighten the nylon rope to achieve full folding of the cardia. After the surgery, the patient fasted overnight and received intravenous PPI treatment. On the second day after surgery, a fluid diet was restored and discharge was possible. ECLC is simple, easy to operate, relatively inexpensive, and minimally invasive, and is expected to become a new method for treating severe gastroesophageal reflux disease.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

endoloop mediated cardioplication (ECLC)

Experimental group

Description:

The ECLC surgery first incises the mucosa and submucosa on the small curvature side and posterior side (approximately 3/4 of the total circumference) of the diaphragm level cardia until smooth muscle fibers are exposed; Fix the metal clip covered with nylon rope on the exposed smooth muscle layer, and finally tighten the nylon rope to achieve full folding of the cardia. After the surgery, the patient fasted overnight and received intravenous PPI treatment. On the second day after surgery, a fluid diet was restored and discharge was possible. ECLC is simple, easy to operate, relatively inexpensive, and minimally invasive, and is expected to become a new method for treating severe gastroesophageal reflux disease.

Treatment:

Procedure: endoloop mediated cardioplication (ECLC) procedure