Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment

NCT06348420 | Recruiting DMC

• 1 other identifier: 2023-QILU-LU 03
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroesophageal Reflux Disease

Keywords

Endoscopic anti-reflux; Proton pump inhibitor; Randomized controlled trial; Gastroesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

• GERD-HRQL

  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, 6 months follow- up

Secondary Outcomes (6)

• GERD-Q score

  at 0, 3, 6 ,12 ,24,36 months follow- up

• DeMeester score

  at 0, 6 and 24 months follow- up

• Presence of reflux esophagitis

  at 0, 6 and 24 months follow- up

• Appearance of the mucosal flap

  at 6 and 24 months follow- up

• PPI use

  at 0, 3, 6 ,12 ,24,36 months follow- up

Study Arms (2)

ARMV (intervention group)

EXPERIMENTAL

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.

Procedure: anti-reflux mucosal valvuloplasty (ARMV)

PPI (control group)

NO INTERVENTION

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.

Interventions

anti-reflux mucosal valvuloplasty (ARMV) PROCEDURE

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.

ARMV (intervention group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Shandong University: collaborator

Study Sites (1)

Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (1)

• Lv X, Ma W, Zeng Y, Lu J. Antireflux mucosal valvuloplasty versus proton pump inhibitors for the treatment of patients with gastro-oesophageal reflux disease in a tertiary healthcare centre in China: study protocol for a randomised controlled trial. BMJ Open. 2024 Dec 22;14(12):e088970. doi: 10.1136/bmjopen-2024-088970.

  PMID: 39773838 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

jiaoyang j lu

CONTACT

18560089069; lujiaoyang@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 4, 2024
• Study Start: September 10, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)