Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease

NCT ID: NCT06153901

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-10
• Study Completion Date: 2024-12-10

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

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 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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux Disease; Endoscopy Upper GI Tract; anti-reflux; Endoscopic therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

endoloop mediated cardioplication (ECLC)

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.

Group Type: EXPERIMENTAL

endoloop mediated cardioplication (ECLC) procedure

Intervention Type: PROCEDURE

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.

Interventions

endoloop mediated cardioplication (ECLC) procedure

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Lu Jiaoyang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2023-QILU-LU 02

Identifier Type: -

Identifier Source: org_study_id