Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China: Study Protocol for a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center
RECRUITING
Jinan
Contact Information
Primary
jiaoyang j lu
lujiaoyang@sdu.edu.cn
18560089069
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 74
Treatments
Experimental: ARMV (intervention group)
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.
No_intervention: PPI (control group)
Patients randomized to the PPI group will follow the PPI treatment scheme. If GERD symptoms are effectively controlled with their current PPI dosage for at least one month, the regimen is decreased by one step. Conversely, if symptoms are poorly controlled, the dosage is increased by one step based on the PPI algorithm, which aligns with best clinical practices. The use of PPI will be recorded in medication diaries using generic names listed in the table below and classified according to the daily dose and frequency. Dosage will be categorized as double dose = ≥30 or 40 mg per day, full dose = 30 or 40 mg per day, half dose = 15 or 20 mg per day, occasional or on demand = \< full dose taken for \< 50% of days in the follow-up period. Common medications include Nexium 20mg、Prevacid 30mg、Prilosec 20mg、Protonix 20mg、Aciphex20mg.The frequency of medication use is once a day.
Sponsors
Leads: Qilu Hospital of Shandong University
Collaborators: Shandong University

This content was sourced from clinicaltrials.gov