Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal Reflux Disease, Endoscopy Upper GI Tract, anti-reflux, Endoscopic therapy
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.
Interventions
PROCEDUREendoloop 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.
Sponsors
Shandong University
Qilu Hospital of Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total score of the GERD-HRQL questionnaire | at 3 month follow- up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total score of GERD GerdQ questionnaire | at 3 month follow- up | 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. |
| Total score of GERD GerdQ and GERD HRQL questionnaires | at 6 and 12 month follow- up | as mentioned above |
| PPI usage | at 3, 6 and 12 month follow- up | 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 |
| Healing status of reflux esophagitis and damaged mucosa | at 3, 6, and 12 months | Repair of esophageal mucosa at the surgical site |
| Safety evaluation indicators | at 0, 3, 6, and 12 months | The incidence of intraoperative and postoperative bleeding and perforation; Postoperative pain score |
| Esophageal acid reflux and DeMeester score | at 3, 6, and 12 months follow- up | 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. |
Outcome results
None listed