Endoloop Mediated Cardioplication to Treat Gastroesophageal Reflux Disease

NCT06153901 | Unknown

• 1 other identifier: 2023-QILU-LU 02
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The total score of the GERD-HRQL questionnaire

  Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.

  at 3 month follow- up

Secondary Outcomes (6)

• PPI usage

  at 3, 6 and 12 month follow- up

• Total score of GERD GerdQ questionnaire

  at 3 month follow- up

• Total score of GERD GerdQ and GERD HRQL questionnaires

  at 6 and 12 month follow- up

• Esophageal acid reflux and DeMeester score

  at 3, 6, and 12 months follow- up

• Healing status of reflux esophagitis and damaged mucosa

  at 3, 6, and 12 months

Study Arms (1)

endoloop mediated cardioplication (ECLC)

EXPERIMENTAL

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.

Procedure: endoloop mediated cardioplication (ECLC) procedure

Interventions

endoloop mediated cardioplication (ECLC) procedure 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.

endoloop mediated cardioplication (ECLC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Shandong University: collaborator

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 10, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share