Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment

Gastroesophageal Reflux Disease Clinical Trial

— ARMV  

Official title:

A Randomized Controlled Trial of Anti-reflux Mucosal Valvuloplasty (ARMV) Versus Proton Pump Inhibitors (PPIs) for Treatment of Gastroesophageal Reflux Disease(GERD): The ARMV vs. PPIs Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348420
• Other study ID #: 2023-QILU-LU 03
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: August 13, 2027

Study information

• Verified date: March 2024
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).

Description:

Under general anesthesia, patients are positioned in the left lateral decubitus position and undergo endoscopic examination of the esophagus and stomach. The surgery utilizes a single-channel gastroscope (EG29-i10, Pentax, Japan, or GIF-H290T, Olympus, Japan) and a high-frequency generator (VIO300D, Erbe, Germany). A transparent cap (D-201, Olympus, Japan) is attached to the gastroscope to improve visualization and aid in manipulating the flap valve. The DualKnife (Olympus, Japan) is selected for dissection due to its maneuverability in a retroflexed fashion. For patients with esophageal strictures obstructing scope passage, esophageal dilation is performed using Savary-Gilliard dilators (Cook Medical, USA) just before ARMV.

During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.

After the ARMV procedure, PPI therapy is continued for 1 month to promote mucosal healing before being discontinued. If symptoms reoccur, the PPI management regimen is reinstated for the ARMV group, with diligent recording of PPI usage in a medication diary.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: August 13, 2027
• Est. primary completion date: April 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 18-60 years of age;

• Hiatal hernia = 2 cm;

• Sliding hernia = 2 cm;

• Recurrence of GERD symptoms after cessation of PPIs;

• On daily PPI for =1 year or twice daily PPI for at least 8 weeks;

• Esophagitis (Los Angeles Classification) Grade B, C, or D;

• Hill's flap valve grade = III;

• Observation of distal esophageal pH < 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%;

• Normal or near-normal esophageal motility;

• Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg;

• DeMeester score = 14.7 or total reflux episodes exceeding 73;

• Completion of a signed informed consent form.

Exclusion Criteria:

• BMI > 35 kg/m2;

• ASA > II;

• Barrett's esophagus;

• Hiatal hernia > 2 cm;

• Esophagitis (Los Angeles Classification) Grade A or No esophagitis;

• Hill's flap valve grade > III;

• Peptic ulcer disease;

• Primary esophageal motility disorders such as achalasia;

• Severe gastroparesis;

• History of previous esophageal or gastric surgery, including ARMS or ARMA;

• Uncontrolled systemic diseases;

• Gastric outlet obstruction;

• Pregnancy or planning to become pregnant.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• anti-reflux mucosal valvuloplasty (ARMV)
During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Shandong University

Outcome

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 to questions 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 0, 3, 6 ,12 ,24,36 month follow- up
Secondary	Number of Participants with PPI usage	Requirement of PPI for control of symptoms. Heartburn and Regurgitation questionnaire 0 =No symptom 1 =Symptoms noticeable but not bothersome 2=Symptoms noticeable and bothersome but not every day 3 =Symptoms bothersome every day 4 =Symptoms affect daily activity 5 =Symptoms are incapacitating to do daily activities.	at 0, 3, 6 ,12 ,24,36 month follow- up
Secondary	Appearance of the mucosal flap	The shape and mobility of the anti-reflux mucosal flap displayed under endoscopy	at 0, 6 and 24 month follow- up
Secondary	Presence of reflux esophagitis	Healing of esophagitis will represent a clinically significant improvement. Treatment success will be defined by a significantly (p < 0.05) higher number of patients with healed esophagitis in the ARMV group vs. PPI group.	at 0, 6 and 24 month follow- up
Secondary	Safety evaluation indicators	The incidence of intraoperative and postoperative bleeding and perforation; Postoperative pain score	at 0, 3, 6 ,12 ,24,36 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 0, 3, 6 ,12 ,24,36 month follow- up
Secondary	DeMeester score	DeMeester score at dynamic esophageal reflux monitoring visits 2 and 4. Esophageal 24-hintraluminal ambulatory pH monitoring is performed to monitor the modality of the reflux. A catheter sensor is placed 5 cm above the proximal border of the lower esophageal sphincter (LES). Each reflux is considered acidic when the pH of the refluxate is less than 4. The acid reflux composite score (DeMeester score) is calculated using the following values: percentage of total time in reflux, percentage of time in reflux in the upright position, percentage of time in reflux in the supine position, the total number of reflux episodes, number of reflux episodes continuing over 5 minutes, and longest duration of reflux among all reflux episodes	at 0, 6 and 24 month follow- up