Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06348420

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

Led by Qilu Hospital of Shandong University · Updated on 2024-11-18

74

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

Q

Qilu Hospital of Shandong University

Lead Sponsor

S

Shandong University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the relative benefits, safety, and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) compared to daily Proton Pump Inhibitors (PPIs) in patients with Gastroesophageal Reflux Disease (GERD). This trial aims to better understand how ARMV, a minimally invasive procedure, compares to standard PPI treatment in managing GERD symptoms and improving patients' quality of life. The ARMV procedure is performed under general anesthesia, using an endoscope to release and reconstruct a segment of mucosa at the esophagogastric junction to form a mucosal flap. This flap is secured with metal clips to prevent flattening and promote reflux prevention. Patients continue PPI therapy for one month after ARMV to aid healing before stopping the medication. The comparison group continues PPI treatment with dosage adjustments based on symptom control. PPI use is carefully recorded in medication diaries. Participants will undergo endoscopic examination and various follow-up assessments including symptom questionnaires, esophageal pH monitoring, and endoscopic evaluations over up to three years. Key outcomes include GERD-related quality of life, reflux scores, esophagitis presence, mucosal flap appearance, PPI usage, and adverse events. Researchers will closely monitor participants' symptoms, medication use, and safety throughout the study period, which lasts until December 2028.

CONDITIONS

Brief Title

Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 60 years of age
  • Hiatal hernia 2 cm or less
  • Sliding hernia 2 cm or less
  • Recurrence of GERD symptoms after stopping PPIs
  • Daily PPI use for at least 1 year or twice daily use for at least 8 weeks
  • Esophagitis Grade B, C, or D (Los Angeles Classification)
  • Hill's flap valve grade 3 or less
  • Distal esophageal pH less than 4 on 1-2 days in a 7-day period exceeding 5.3%
  • Normal or near-normal esophageal motility
  • Lower esophageal sphincter pressure between 5 and 15 mmHg
  • DeMeester score 14.7 or higher or total reflux episodes more than 73
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Body Mass Index over 35 kg/m2
  • ASA physical status greater than II
  • Barrett's esophagus
  • Hiatal hernia larger than 2 cm
  • Esophagitis Grade A or no esophagitis
  • Hill's flap valve grade greater than 3
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 month or more depending on treatment group and symptom control

Participants undergo either the anti-reflux mucosal valvuloplasty (ARMV) procedure under general anesthesia or follow a proton pump inhibitor (PPI) medication regimen to manage GERD symptoms.

1 procedure visit for ARMV group; ongoing medication use with monitoring for PPI group

Follow-up

Duration - Up to 36 months

Participants are followed for up to 36 months to monitor symptoms, medication use, and any adverse events.

Visits at 3, 6, 12, 24, and 36 months for symptom and safety assessments

Trial Site Locations

Total: 1 location

1

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

Jinan, Shandong, China, 250000

Actively Recruiting

Loading map...

Research Team

J

jiaoyang j lu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Multicenter, Active-controlled, Randomized, Double-blind Cli...

Gastroesophageal Reflux Disease

Actively Recruiting

2 locations

Treatment Protocol for the Compassionate Use of Domperidone ...

Digestive System Disorder

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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.

Xiaofen Lv, Wenlong Ma, Yunqing Zeng...

https://pubmed.ncbi.nlm.nih.gov/39773838