Gastroesophageal Reflux Disease Clinical Trial
Official title:
Metal Clip and Endoloop Mediated Endoscopic Cardioplication (ECLC) for the Treatment of Gastroesophageal Reflux Disease (GERD):a Prospective Cohort Study
Verified date | November 2023 |
Source | Qilu Hospital of Shandong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 35 |
Est. completion date | December 10, 2024 |
Est. primary completion date | December 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Qilu Hospital of Shandong University | Shandong University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | PPI usage | Requirement of PPI for control of symptoms at 3, 6 and 12 months Heartburn and Regurgitation questionnaire 0 =No symptom 1 =Symptoms noticeablebut not bothersome 2=S ymptoms noticeableand bothersome but noteve ry day 3 =Symptoms bothersome every day 4 =Symptoms affect daily activity 5 =Symptoms are incapacitating to do daily activities | at 3, 6 and 12 month follow- up | |
Secondary | Total score of GERD GerdQ questionnaire | Questionnaire (GERD-GerdQ ) : Recall the frequency of burning sensation (heartburn) after your sternum in the past 7 days;How often do you feel stomach contents (liquid or food) returning to your throat or mouth (reflux) in the past 7 days?How often did you feel pain in the center of your upper abdomen in the past 7 days?How often did you feel nauseous in the past 7 days?How often have you had difficulty getting good night sleep due to heartburn and/or reflux in the past 7 days? Looking back on the past 7 days, in addition to the medication advised by the doctor, did you take additional medication to alleviate the frequency of heartburn and/or reflux? (such as calcium carbonate, aluminum hydroxide, and other antacids).0 days are 0 points, 1 day is 1 point, 2-3 days are 2 points, and 4-7 days are 3 points. Add up the scores for each item to obtain the total score. | at 3 month follow- up | |
Secondary | Total score of GERD GerdQ and GERD HRQL questionnaires | as mentioned above | at 6 and 12 month follow- up | |
Secondary | Esophageal acid reflux and DeMeester score | There are three monitoring indicators: (1) Total acid exposure time: percentage of total time with pH<4 in 24 hours, standing and lying positions; (2) Acid exposure frequency: number of times with pH<4; (3) Duration of acid exposure: number of times with reflux duration = 5 minutes and maximum reflux duration. The above indicators were calculated using the Demester system of the computer to obtain the total score. Foreign data suggests a normal value of<14.72, while limited domestic data suggests a value of<12.4. The normal 24-hour esophageal pH reference value is: the total time for pH<4 is<4%, the number of reflux times within 5 minutes is = 2, and the longest reflux duration is<16 minutes. | at 3, 6, and 12 months follow- up | |
Secondary | Healing status of reflux esophagitis and damaged mucosa | Repair of esophageal mucosa at the surgical site | at 3, 6, and 12 months | |
Secondary | Safety evaluation indicators | The incidence of intraoperative and postoperative bleeding and perforation; Postoperative pain score | at 0, 3, 6, and 12 months |
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