Evidence map›Paper›PMID 31289058›Full record

ArticleBMJ open2019

Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study): protocol of a multicentre randomised clinical trial.

Levente Pál Kucserik, Katalin Márta, Áron Vincze, György Lázár, László Czakó, Zsolt Szentkereszty, Mária Papp, Károly Palatka, Ferenc Izbéki, Áron Altorjay and 16 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 24% 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.

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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. 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

26 authors at 12 institutions in 5 countries.

Levente Pál KucserikDivision of Surgery, Universitatea de Medicina si Farmacie din Targu Mures, Targu Mures, Romania.
Katalin MártaInstitute for Translational Medicine, Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pecs, Hungary.
Áron VinczeInstitute for Translational Medicine, Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pecs, Hungary.
György LázárDepartment of Surgery, University of Szeged, Szeged, Hungary.
László CzakóFirst Department of Medicine, University of Szeged, Szeged, Hungary.
Zsolt SzentkeresztyDepartment for Surgery, University of Debrecen, Debrecen, Hungary.
Mária PappDivision of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Debreceni Egyetem, Debrecen, Hungary.
Károly PalatkaDivision of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Debreceni Egyetem, Debrecen, Hungary.
Ferenc IzbékiDivison of Gastroenterology, Fejer County Saint George Teaching Hospital of University of Pécs, Székesfehérvár, Hungary.
Áron AltorjayDivision of Surgery, Fejer County Saint George Teaching Hospital of University of Pécs, Székesfehérvár, Hungary.
Imola TörökDivision of Gastroenterology, Universitatea de Medicina si Farmacie din Targu Mures, Targu Mures, Romania.
Sorin Barbu4thSurgery Department, "Iuliu Hatieganu" University of Medicine & Pharmacy, Cluj-Napoca, Romania.
Marcel Tantau4thSurgery Department, "Iuliu Hatieganu" University of Medicine & Pharmacy, Cluj-Napoca, Romania.
András VereczkeiDepartment for Surgery, Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pecs, Hungary.
Lajos BogárDepartment of Anaesthesiology and Intensive Therapy, Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pecs, Hungary.
Márton DénesSecond Department of Surgery, County Hospital Targu Mures, Targu Mures, Romania.
Imola NémethData-Management, Pre-Clinical and Clinical Biostatistics, Adware Research Developing and Consulting Ltd, Balatonfüred, Hungary.
Andrea SzentesiInstitute for Translational Medicine, Pecsi Tudomanyegyetem, Pecs, Hungary.
Noémi ZádoriInstitute for Translational Medicine, Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pecs, Hungary.
Judit AntalInstitute for Translational Medicine, Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pecs, Hungary.
Markus M LerchDepartment of Medicine A, Universitatsmedizin Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany.
John NeoptolemosDepartment of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, Liverpool, UK.
Miklós Sahin-TóthDepartment of Molecular and Cell Biology, Henry M. Goldman School of Dental Medicine, Boston University, Boston, MA 02118, USA.
Ole H PetersenSchool of Biosciences, Cardiff University, Cardiff, South Glamorgan, UK.
Dezső Kelemen *Surgery Clinic, Pecsi Tudomanyegyetem, Pecs, Hungary.
Péter Hegyi *Institute for Translational Medicine, Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pecs, Hungary.ORCID 0000-0002-7035-941X
University of Pecs · HUUniversity of Debrecen · HUUniversity of Szeged · HUIuliu Hațieganu University of Medicine and Pharmacy · ROUniversitatea de Medicină, Farmacie, Științe și Tehnologie „George Emil Palade” din Târgu Mureș · ROBoston University · USCardiff University · GBKodolányi János University of Applied Sciences · HUMTA-SZTE Research Group on Artificial Intelligence · HUSpitalul Clinic Judetean de Urgenta Târgu Mureş · ROUniversitätsmedizin Greifswald · DEUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAccording to the literature, early cholecystectomy is necessary to avoid complications related to gallstones after an initial episode of acute biliary pancreatitis (ABP). A randomised, controlled multicentre trial (the PONCHO trial) revealed that in the case of gallstone-induced pancreatitis, early cholecystectomy was safe in patients with mild gallstone pancreatitis and reduced the risk of recurrent gallstone-related complications, as compared with interval cholecystectomy. We hypothesise that carrying out a sphincterotomy (ES) allows us to delay cholecystectomy, thus making it logistically easier to perform and potentially increasing the efficacy and safety of the procedure. METHODS/

designEMILY is a prospective, randomised, controlled multicentre trial. All patients with mild ABP, who underwent ES during the index admission or in the medical history will be informed to take part in EMILY study. The patients will be randomised into two groups: (1) early cholecystectomy (within 6 days after discharge) and (2) patients with delayed (interval) cholecystectomy (between 45 and 60 days after discharge). During a 12-month period, 93 patients will be enrolled from participating clinics. The primary endpoint is a composite endpoint of mortality and recurrent acute biliary events (that is, recurrent ABP, acute cholecystitis, uncomplicated biliary colic and cholangitis). The secondary endpoints are organ failure, biliary leakage, technical difficulty of the cholecystectomy, surgical and other complications. ETHICS AND DISSEMINATION: The trial has been registered internationally ISRCTN 10667869, and approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (EKU/2018/12176-5). TRIAL REGISTRATION NUMBER: ISCRTN 10667869; Pre-results.

Indexed as

Sphincterotomy, EndoscopicAdultCholangiopancreatography, Endoscopic RetrogradeCholecystectomyCholecystitis, AcuteFemaleGallstonesHumansMaleMiddle AgedMulticenter Studies as TopicPancreatitisProspective StudiesRandomized Controlled Trials as TopicTime Factorsacute biliary pancreatitischolecystectomyendoscopic sphincterotomy

Identifiers

PMID31289058
PMCPMC6629406
OpenAlexW2971844917

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.