Evidence map›Paper›PMID 26729193›Full record

Trial reportTrials2016

Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial.

Nicolien J Schepers, Olaf J Bakker, Marc G H Besselink, Thomas L Bollen, Marcel G W Dijkgraaf, Casper H J van Eijck, Paul Fockens, Erwin J M van Geenen, Janneke van Grinsven, Nora D L Hallensleben and 30 more

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.3field-weighted citation impact, top 4% 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

14 citing papers in PubMed, 50 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Observational
  10. Article
  11. New insights into acute pancreatitis.Nature reviews. Gastroenterology & hepatology · 2019
    Review
  12. Article
  13. Review
  14. 2019 WSES guidelines for the management of severe acute pancreatitis.World journal of emergency surgery : WJES · 2019
    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

40 authors at 20 institutions in 3 countries.

Nicolien J SchepersDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, PO 2040, 3000, CA, Rotterdam, The Netherlands. n.schepers@pancreatitis.nl.
Olaf J BakkerDepartment of Surgery, University Medical Center Utrecht, PO 85500, 3508, GA, Utrecht, The Netherlands. o.j.bakker@umcutrecht.nl.
Marc G H BesselinkDepartment of Surgery, Academic Medical Center University of Amsterdam, PO 22660, 1100, DD, Amsterdam, The Netherlands. m.g.besseling@amc.nl.
Thomas L BollenDepartment of Radiology, St Antonius Hospital, PO 2500, 3430, EM, Nieuwegein, The Netherlands. t.bollen@antoniusziekenhuis.nl.
Marcel G W DijkgraafClinical Research Unit, Academic Medical Center University of Amsterdam, PO 22660, 1100, DD, Amsterdam, The Netherlands. m.g.dijkgraaf@amc.nl.
Casper H J van EijckDepartment of Surgery, Erasmus Medical Center, PO 2040, 3000, CA, Rotterdam, The Netherlands. c.vaneijck@erasmusmc.nl.
Paul FockensDepartment of Gastroenterology and Hepatology, Academic Medical Center University of Amsterdam, PO 22660, 1100, DD, Amsterdam, The Netherlands. p.fockens@amc.nl.
Erwin J M van GeenenDepartment of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre, HP 690, PO 9101, 6500, HB, Nijmegen, The Netherlands. erwin.vangeenen@radboudumc.nl.
Janneke van GrinsvenDepartment of Surgery, Academic Medical Center University of Amsterdam, PO 22660, 1100, DD, Amsterdam, The Netherlands. j.vangrinsven@pancreatitis.nl.
Nora D L HallenslebenDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, PO 2040, 3000, CA, Rotterdam, The Netherlands. n.hallensleben@pancreatitis.nl.
Bettina E HansenDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, PO 2040, 3000, CA, Rotterdam, The Netherlands. b.hansen@erasmusmc.nl.
Hjalmar C van SantvoortDepartment of Surgery, St Antonius Hospital, PO 2500, 3430, EM, Nieuwegein, The Netherlands. h.van.santvoort@antoniusziekenhuis.nl.
Robin TimmerDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, PO 2040, 3000, CA, Rotterdam, The Netherlands. r.timmer@antoniusziekenhuis.nl.
Marie-Paule G F AntenDepartment of Gastroenterology and Hepatology, Sint Franciscus Gasthuis, PO 10900, 3004, BA, Rotterdam, The Netherlands. m.anten@sfvg.nl.
Clemens J M BolwerkDepartment of Gastroenterology and Hepatology, Reinier de Graaf Hospital, Reinier de Graafweg 3-11, 2625, AD, Delft, The Netherlands. clemens@bolwerkdega.com.
Foke van DelftDepartment of Gastroenterology and Hepatology, VU University Medical Center Amsterdam, PO Box 7057, 1007, MB, Amsterdam, The Netherlands. f.vandelft@vumc.nl.
Hendrik M van DullemenDepartment of Gastroenterology and Hepatology, University Medical Center Groningen, PO 30001, 9700, RB, Groningen, The Netherlands. h.m.dullemen@umcg.nl.
G Willemien ErkelensDepartment of Gastroenterology and Hepatology, Gelre Hospital, PO 9014, 7300, DS, Apeldoorn, The Netherlands. w.erkelens@gelre.nl.
Jeanin E van HooftDepartment of Gastroenterology and Hepatology, Academic Medical Center University of Amsterdam, PO 22660, 1100, DD, Amsterdam, The Netherlands. j.vanhooft@amc.nl.
Robert LaheijDepartment of Gastroenterology and Hepatology, St. Elisabeth Hospital, PO 90151, 5000, LC, Tilburg, The Netherlands. r.laheij@elisabeth.nl.
René W M van der HulstDepartment of Gastroenterology and Hepatology, Kennemer Gasthuis, PO 417, 2000, AK, Haarlem, The Netherlands. hulst@kg.nl.
Jeroen M JansenDepartment of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Postbus 95500, 1090, HM, Amsterdam, The Netherlands. j.m.jansen@olvg.nl.
Frank J G M KubbenDepartment of Gastroenterology and Hepatology, Maasstad Hospital, Maasstadweg 21, 3079, DZ, Rotterdam, The Netherlands. kubbenf@maasstadziekenhuis.nl.
Sjoerd D KuikenDepartment of Gastroenterology and Hepatology, Sint Lucas Andreas Hospital, PO 9243, 1006, AE, Amsterdam, The Netherlands. s.kuiken@slaz.nl.
Lars E PerkDepartment of Gastroenterology and Hepatology, Medical Center Haaglanden, PO 432, 2501, CK Den Haag, The Netherlands. l.perk@mch.nl.
Rogier J J de RidderDepartment of Gastroenterology and Hepatology, Maastricht University Medical Center, PO 5800, 6202, AZ, Maastricht, The Netherlands. r.de.ridder@mumc.nl.
Marno C M RijkDepartment of Gastroenterology and Hepatology, Amphia Hospital, PO 90158, 4800, RK, Breda, The Netherlands. mrijk@amphia.nl.
Tessa E H RömkensDepartment of Gastroenterology and Hepatology, Jeroen Bosch Hospital, PO 90153, 5200, ME 's-Hertogenbosch, The Netherlands. t.romkens@jbz.nl.
Erik J SchoonDepartment of Gastroenterology and Hepatology, Catharina Hospital, PO 1350, 5602, ZA, Eindhoven, The Netherlands. erik.schoon@catharinaziekenhuis.nl.
Matthijs P SchwartzDepartment of Gastroenterology and Hepatology, Meander Medical Center, PO 1502, 3800, BM, Amersfoort, The Netherlands. mp.schwartz@meander.nl.
B W Marcel SpanierDepartment of Gastroenterology and Hepatology, Rijnstate Hospital, PO 9555, 6800, TA, Arnhem, The Netherlands. m.spanier@rijnstate.nl.
Adriaan C I T L TanDepartment of Gastroenterology and Hepatology, Canisius-Wilhelmina Hospital, PO 9015, 6500, GS, Nijmegen, The Netherlands. a.tan@cwz.nl.
Willem J ThijsDepartment of Gastroenterology and Hepatology, Martini Hospital, PO 30033, 9700, RM, Groningen, The Netherlands. thijsw@mz.nl.
Niels G VennemanDepartment of Gastroenterology and Hepatology, Medisch Spectrum Twente, PO 50000, 7500, KA, Enschede, The Netherlands. n.venneman@mst.nl.
Frank P VleggaarDepartment of Gastroenterology and Hepatology, University Medical Center Utrecht, PO 85500, 3508, GA, Utrecht, The Netherlands. f.vleggaar@umcutrecht.nl.
Wim van de VrieDepartment of Gastroenterology and Hepatology, Albert Schweitzer Hospital, PO 444, 3300, AK, Dordrecht, The Netherlands. w.vandevrie@asz.nl.
Ben J WittemanDepartment of Gastroenterology and Hepatology, Hospital Gelderse Vallei Ede, PO 9025, 6710, HN, Ede, The Netherlands. b.witteman@zgv.nl.
Hein G GooszenDepartment of Operating Rooms - Evidence Based Surgery, Radboud University Nijmegen Medical Centre, HP 690, PO 9101, 6500, HB, Nijmegen, The Netherlands. hein.gooszen67@hotmail.com.
Marco J BrunoDepartment of Gastroenterology and Hepatology, Erasmus Medical Center, PO 2040, 3000, CA, Rotterdam, The Netherlands. m.bruno@erasmusmc.nl.
Dutch Pancreatitis Study Group
Erasmus MC · NLRadboud University Nijmegen · NLAmsterdam UMC Location University of Amsterdam · NLMedisch Spectrum Twente · NLOLVG · NLUniversity Medical Center Groningen · NLUtrecht University · NLAlbert Schweitzer Ziekenhuis · NLAmphia Ziekenhuis · NLCanisius-Wilhelmina Ziekenhuis · NLGelre Hospitals · NLMaastricht University Medical Centre · NLMartini Ziekenhuis · NLMedisch Centrum Haaglanden · NLReinier de Graaf Hospital · NLRijnstate Hospital · NLSint Franciscus Gasthuis · NLSint Lucas Andreas Hospital · NLSt. Elisabeth Hospital · CWUniversity Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute pancreatitis is mostly caused by gallstones or sludge. Early decompression of the biliary tree by endoscopic retrograde cholangiography (ERC) with sphincterotomy may improve outcome in these patients. Whereas current guidelines recommend early ERC in patients with concomitant cholangitis, early ERC is not recommended in patients with mild biliary pancreatitis. Evidence on the role of routine early ERC with endoscopic sphincterotomy in patients without cholangitis but with biliary pancreatitis at high risk for complications is lacking. We hypothesize that early ERC with sphincterotomy improves outcome in these patients. METHODS/

designThe APEC trial is a randomized controlled, parallel group, superiority multicenter trial. Within 24 hours after presentation to the emergency department, patients with biliary pancreatitis without cholangitis and at high risk for complications, based on an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 8 or greater, Modified Glasgow score of 3 or greater, or serum C-reactive protein above 150 mg/L, will be randomized. In 27 hospitals of the Dutch Pancreatitis Study Group, 232 patients will be allocated to early ERC with sphincterotomy or to conservative treatment. The primary endpoint is a composite of major complications (that is, organ failure, pancreatic necrosis, pneumonia, bacteremia, cholangitis, pancreatic endocrine, or exocrine insufficiency) or death within 180 days after randomization. Secondary endpoints include ERC-related complications, infected necrotizing pancreatitis, length of hospital stay and an economical evaluation. DISCUSSION: The APEC trial investigates whether an early ERC with sphincterotomy reduces the composite endpoint of major complications or death compared with conservative treatment in patients with biliary pancreatitis at high risk of complications.

trial registrationCurrent Controlled Trials ISRCTN97372133 (date registration: 17-12-2012).

Indexed as

Clinical ProtocolsAcute DiseaseBiliary Tract Surgical ProceduresCholangiographyDecompression, SurgicalHumansPancreatitisSample SizeSphincterotomy, Endoscopic

Identifiers

PMID26729193
PMCPMC4700728
OpenAlexW2229209002

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.