Evidence mapPaperPMID 35470243Full record

Trial reportGut2022

Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial.

Jan Martinek, Rastislav Hustak, Jan Mares, Zuzana Vackova, Julius Spicak, Eva Kieslichova, Marie Buncova, Daniel Pohl, Sunil Amin, Jan Tack

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 2 pooled it
19.0field-weighted citation impact, top 1% of its field
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.

NCT03356067 nacompletednot on this map

A Randomized, Sham and Cross-Over-Controlled Trial of Per-oral Endoscopic Pyloromyotomy (G-POEM) in Patients With Refractory Gastroparesis

TypeinterventionalSponsorInstitute for Clinical and Experimental MedicineRan2017 to 2021Enrolled42ConditionsGastroparesisArmsGastric endoscopic peroral pyloromyotomy, Esophago-gastro-duodenoscopy
NCT06340217 narecruitingnot on this mapstarted 2024, after this paper: background citation

The Efficacy and Safety of WMT in the Treatment of Diabetic Gastroparesis: A Multicenter, Randomized, Double-blind, Placebo-controlled Study

TypeinterventionalSponsorThe Second Hospital of Nanjing Medical UniversityRan2024 to 2029Enrolled46ConditionsDiabetic GastroparesisArmswashed microbiota transplantation, placebo
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 2 syntheses or guidelines pooled it, 122 citations in OpenAlex.

  1. Guideline
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  12. Progress in Gastroparesis Management: From Pharmacotherapy to Interventional Treatments.JGH open : an open access journal of gastroenterology and hepatology · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 5 countries.

Jan MartinekDepartment of Hepatogastroenterology, Institute of Clinical and Experimental Medicine, Praha, Czech Republic jan.martinek@volny.cz.ORCID 0000-0002-1415-4719
Rastislav HustakDepartment of Internal Medicine, University Hospital Trnava, Trnava, Slovakia.ORCID 0000-0001-8669-9024
Jan MaresDepartment of IT and Biostatistics, Institute of Clinical and Experimental Medicine, Praha, Czech Republic.ORCID 0000-0002-4727-3685
Zuzana VackovaDepartment of Hepatogastroenterology, Institute of Clinical and Experimental Medicine, Praha, Czech Republic.ORCID 0000-0002-0443-5752
Julius SpicakDepartment of Hepatogastroenterology, Institute of Clinical and Experimental Medicine, Praha, Czech Republic.
Eva KieslichovaDepartment of Anesthesiology and Intensive Care, Institute of Clinical and Experimental Medicine, Praha, Czech Republic.
Marie BuncovaDepartment of Nuclear Medicine, Institute of Clinical and Experimental Medicine, Praha, Czech Republic.
Daniel PohlDivision of Gastroenterology & Hepatology, University Hospital Zürich, Zürich, Switzerland.ORCID 0000-0002-0855-1152
Sunil AminDivision of Gastroenterology, University of Miami Miller School of Medicine, Miami, Florida, USA.ORCID 0000-0002-3067-4730
Jan TackClinical and Experimental Medicine, University of Leuven, Leuven, Belgium.ORCID 0000-0002-3206-6704
Institute of Clinical and Experimental Medicine · CZKU Leuven · BEUniversity Hospital of Zurich · CHUniversity of Miami · USUniversity of Trnava · SK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveEndoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis.

designIn this prospective randomised trial, we compared G-POEM with a sham procedure in patients with severe gastroparesis. The primary outcome was the proportion of patients with treatment success (defined as a decrease in the Gastroparesis Cardinal Symptom Index (GCSI) by at least 50%) at 6 months. Patients randomised to the sham group with persistent symptoms were offered cross-over G-POEM.

resultsThe enrolment was stopped after the interim analysis by the Data and Safety Monitoring Board prior to reaching the planned sample of 86 patients. A total of 41 patients (17 diabetic, 13 postsurgical, 11 idiopathic; 46% male) were randomised (21 G-POEM, 20-sham). Treatment success rate was 71% (95% CI 50 to 86) after G-POEM versus 22% (8-47) after sham (p=0.005). Treatment success in patients with diabetic, postsurgical and idiopathic gastroparesis was 89% (95% CI 56 to 98), 50% (18-82) and 67% (30-90) after G-POEM; the corresponding rates in the sham group were 17% (3-57), 29% (7-67) and 20% (3-67).Median gastric retention at 4 hours decreased from 22% (95% CI 17 to 31) to 12% (5-22) after G-POEM and did not change after sham: 26% (18-39) versus 24% (11-35). Twelve patients crossed over to G-POEM with 9 of them (75%) achieving treatment success.

conclusionIn severe gastroparesis, G-POEM is superior to a sham procedure for improving both symptoms and gastric emptying 6 months after the procedure. These results are not entirely conclusive in patients with idiopathic and postsurgical aetiologies. TRIAL REGISTRATION NUMBER: NCT03356067; ClinicalTrials.gov.

Indexed as

GastroparesisPyloromyotomyFemaleGastric EmptyingGastroscopyHumansMaleProspective StudiesTreatment OutcomeGASTRIC EMPTYINGGASTROPARESIS

Identifiers

PMID35470243
PMCPMC9554080
OpenAlexW4224936623

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.