Clinical trial NCT06348420: Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: Endoscopic anti-reflux
Proton pump inhibitor
Randomized controlled trial
Gastroesophageal reflux disease
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong University
First posted: 2024-04-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: GERD-HRQL
timeFrame: at 0, 6 months follow- up
Secondary outcomes:
measure: GERD-Q score
timeFrame: at 0, 3, 6 ,12 ,24,36 months follow- up
measure: DeMeester score
timeFrame: at 0, 6 and 24 months follow- up
measure: Presence of reflux esophagitis
timeFrame: at 0, 6 and 24 months follow- up
measure: Appearance of the mucosal flap
timeFrame: at 6 and 24 months follow- up
measure: PPI use
timeFrame: at 0, 3, 6 ,12 ,24,36 months follow- up
measure: Incidence of adverse events
timeFrame: at 3, 6 ,12 ,24,36 months follow- up
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center
state: Shandong
Study officials:
References: