Evidence map›Paper›PMID 39773838›Full record

ArticleBMJ open2024

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, Jiaoyang Lu

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06348420 (Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06348420 narecruitingnot on this map

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

TypeinterventionalSponsorQilu Hospital of Shandong UniversityRan2024 to 2028Enrolled74ConditionsGastroesophageal Reflux DiseaseArmsanti-reflux mucosal valvuloplasty (ARMV)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Xiaofen LvDepartment of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Wenlong MaDepartment of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Yunqing ZengDepartment of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China.
Jiaoyang LuDepartment of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China lujiaoyang@sdu.edu.cn.ORCID http://orcid.org/0000-0002-6859-8390

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEndoscopic antireflux therapy has shown promising potential in the treatment for gastro-oesophageal reflux disease (GERD). However, there is currently no universally accepted standard for endoscopic surgery. Therefore, we introduced antireflux mucosal valvuloplasty (ARMV), an innovative endoscopic treatment for GERD. We have conducted a cohort study to assess the association between ARMV and clinical outcomes, including risks and benefits. The objective of this trail is to compare the efficacy of ARMV with proton pump inhibitors (PPIs) therapy. METHODS AND ANALYSIS: 74 patients with chronic GERD will be randomised (1:1) to undergo either ARMV or continue PPI therapy. The primary endpoint is the GERD health-related quality of life score, measured 6 months postprocedure. Secondary endpoints include the GERD questionnaire score, presence of reflux oesophagitis, appearance of the mucosal flap, DeMeester score, PPI usage and the incidence of adverse events. After 6 months, crossover is allowed for the PPI group. Assessments will occur at baseline and at 3, 6, 12, 24 and 36 months postintervention. ETHICS AND DISSEMINATION: The study protocol has been approved by the Institutional Review Board of Qilu Hospital, Shandong University. Study results will be disseminated through peer-reviewed journals and presented at scientific conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT06348420).

Indexed as

Gastroesophageal RefluxProton Pump InhibitorsTertiary Care CentersAdultChinaFemaleHumansMaleMiddle AgedQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeProton Pump InhibitorsAdult gastroenterologyClinical TrialEndoscopyResearch Design

Identifiers

PMID39773838
PMCPMC11667400

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.