Clinical trial NCT06153901: Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease
Official title: Metal Clip and Endoloop Mediated Endoscopic Cardioplication (ECLC) for the Treatment of Gastroesophageal Reflux Disease (GERD):a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal Reflux Disease
Endoscopy Upper GI Tract
anti-reflux
Endoscopic therapy
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong University
First posted: 2023-12-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The total score of the GERD-HRQL questionnaire
timeFrame: at 3 month follow- up
Secondary outcomes:
measure: PPI usage
timeFrame: at 3, 6 and 12 month follow- up
measure: Total score of GERD GerdQ questionnaire
timeFrame: at 3 month follow- up
measure: Total score of GERD GerdQ and GERD HRQL questionnaires
timeFrame: at 6 and 12 month follow- up
measure: Esophageal acid reflux and DeMeester score
timeFrame: at 3, 6, and 12 months follow- up
measure: Healing status of reflux esophagitis and damaged mucosa
timeFrame: at 3, 6, and 12 months
measure: Safety evaluation indicators
timeFrame: at 0, 3, 6, and 12 months
Other outcomes:
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