Evidence map›Paper›PMID 40551220›Full record

ArticleTrials2025

Prophylactic endoscopic pylorus dilatation prior to esophagectomy for esophageal cancer to prevent delayed gastric emptying, study protocol for a placebo-controlled randomized trial (PROPPER trial).

C Mann, F Berlth, V J Lozanovski, M Passalacqua, E Hadzijusufovic, E Uzun, G Capovilla, M Valmasoni, H Lang, P P Grimminger

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
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

10 authors.

C Mann *Department of General, Visceral, and Transplantation Surgery, University Medical Center Mainz, Mainz, Germany.
F Berlth *Department of General, Visceral, and Transplant Surgery, University Hospital Tübingen, Tübingen, Germany.
V J LozanovskiDepartment of General, Visceral, and Transplantation Surgery, University Medical Center Mainz, Mainz, Germany.
M PassalacquaDepartment of General, Visceral, and Transplantation Surgery, University Medical Center Mainz, Mainz, Germany.
E HadzijusufovicDepartment of General, Visceral, and Transplantation Surgery, University Medical Center Mainz, Mainz, Germany.
E UzunDepartment of General, Visceral, and Transplantation Surgery, University Medical Center Mainz, Mainz, Germany.
G CapovillaCenter for Esophageal Diseases - Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy.
M ValmasoniCenter for Esophageal Diseases - Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Padua, Italy.
H LangDepartment of General, Visceral, and Transplantation Surgery, University Medical Center Mainz, Mainz, Germany.
P P GrimmingerDepartment of General, Visceral, and Transplantation Surgery, University Medical Center Mainz, Mainz, Germany. peter.grimminger@unimedizin-mainz.de.ORCID http://orcid.org/0000-0002-1859-9213

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDelayed gastric emptying (DGE) due to pyloric dysfunction remains a common postoperative complication after esophagectomy for cancer and can lead to severe secondary complications. As shown in a retrospective study, prophylactic EPBD performed 1 day before surgery can reduce the rate of postoperative DGE by reducing pyloric resistance. The objective of this study is to analyze the effect of prophylactic EPBD on postoperative DGE rates in patients receiving minimally invasive esophagectomy for cancer by gastric pull-up.

methodsThis study is designed as a multicenter randomized controlled trial (RCT) including patients with esophageal cancer or cancer of the gastroesophageal junction (adenocarcinoma and squamous cell carcinoma, with or without neoadjuvant treatment) scheduled for minimally invasive esophagectomy with gastric pull-up. After randomization, patients will either receive preoperative EPBD or a sham intervention in the routine preoperative endoscopy performed 1 day before surgery. The primary endpoint of this study will be rates of DGE, particularly those resulting from pyloric dysfunction, requiring intervention. Secondary outcomes will be major and minor postoperative complication rates, in-hospital mortality, adverse events during gastroscopy, length of ICU and hospital stay as well as postoperative pain and quality of life. In order to detect a difference between both groups at a two-sided 5% significance level, to achieve a power of 0.8 with a calculated dropout rate of approximately 20%, a sample size of 118 patients with 59 patients in every study arm will be needed. DISCUSSION: The presented PROPPER trial is the first multicenter RCT that will provide evidence regarding the efficacy of preoperative EPBD in reducing DGE after minimally invasive esophagectomy for cancer.

trial registrationThis trial was registered in the German Clinical Trials Register (DRKS), under the identifier DRKS00034360. Registered on May 29, 2024. The WHO trial registration data set can be found here: http://drks.de/search/en/trial/DRKS00034360 .

Indexed as

DilatationEsophageal NeoplasmsEsophagectomyGastric EmptyingGastroparesisPostoperative ComplicationsPylorusFemaleHumansMaleMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeGastric emptyingGastric pull-upIvor–Lewis esophagectomyMinimally invasive esophagectomyPneumatic dilatation

Identifiers

PMID40551220
PMCPMC12183813

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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.