Evidence map›Paper›PMID 37004078›Full record

ArticleTrials2023

BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis-a study protocol for a multicenter, randomized, controlled parallel group trial.

Klaus Stahl, Friederike Klein, Torsten Voigtländer, Anika Großhennig, Thorsten Book, Tobias Müller, Alexander Wree, Armin Kuellmer, Jochen Weigt, Alexander Dechene and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05396755 (Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis - a Multicenter, Randomized Controlled, Parallel Group Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 31% 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.

NCT05396755 naterminatednot on this map

Biliary Interventions in Critically Ill Patients With Secondary Sclerosing Cholangitis - a Multicenter, Randomized Controlled, Parallel Group Trial

TypeinterventionalSponsorHannover Medical SchoolRan2022 to 2023Enrolled1ConditionsSecondary Sclerosing CholangitisArmsEndoscopic retrograde cholangiography (ERC)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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

19 authors at 9 institutions in 1 country.

Klaus StahlHannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology, Carl-Neuberg Strasse 1, 30625, Hannover, Germany. stahl.klaus@mh-hannover.de.ORCID http://orcid.org/0000-0002-4833-6035
Friederike KleinHannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology, Carl-Neuberg Strasse 1, 30625, Hannover, Germany.
Torsten VoigtländerDepartment of Gastroenterology, Clementinenkrankenhaus Hannover, Hannover, Germany.
Anika GroßhennigDepartment of Biostatistics, Hannover Medical School, Hannover, Germany.
Thorsten BookDepartment of Gastroenterology, Clementinenkrankenhaus Hannover, Hannover, Germany.
Tobias MüllerDepartment of Hepatology and Gastroenterology, Charite University Medicine Berlin, Campus Charite Mitte/Campus Virchow Clinic, Berlin, Germany.
Alexander WreeDepartment of Hepatology and Gastroenterology, Charite University Medicine Berlin, Campus Charite Mitte/Campus Virchow Clinic, Berlin, Germany.
Armin KuellmerClinic for Gastroenterology, Hepatology, Endocrinology and Infectious Diseases, University Hospital Freiburg, Freiburg, Germany.
Jochen WeigtClinic for Gastroenterology, Hepatology and Infectious Diseases, University Hospital Magdeburg, Magdeburg, Germany.
Alexander DecheneDepartment of Gastroenterology and Endocrinology, Hospital Nurnberg, Nurnberg, Germany.
Edris WediDepartment of Gastroenterology, Gastro-Oncology and Interventional Endoscopy, Sana Hospital Offenbach, Offenbach, Germany.
Arne KandulskiDepartment of Gastroenterology, Endocrinology, Infectious Diseases and Rheumatology, University Hospital Regensburg, Regensburg, Germany.
Christian M LangeDepartment of Gastroenterology and Hepatology, University Hospital Munich (LMU), Munich, Germany.
Dennis HolzwartDepartment of Biostatistics, Hannover Medical School, Hannover, Germany.
Dorothee von WitzendorffHannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology, Carl-Neuberg Strasse 1, 30625, Hannover, Germany.
Kristina I RingeDepartment of Diagnostic and Interventional Radiology, Hannover Medical School, Hannover, Germany.
Heiner WedemeyerHannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology, Carl-Neuberg Strasse 1, 30625, Hannover, Germany.
Benjamin HeidrichHannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology, Carl-Neuberg Strasse 1, 30625, Hannover, Germany.
BISCIT Study group
Medizinische Hochschule Hannover · DELMU Klinikum · DECharité - Universitätsmedizin Berlin · DEVinzenzkrankenhaus Hannover · DENuremberg Hospital · DESana Klinikum Offenbach · DEUniversity Hospital Magdeburg · DEUniversity Hospital Regensburg · DEUniversity Medical Center Freiburg · DE

Funding

Deutsche Forschungsgemeinschaft VO 2458/1-1
6 · The paper itself

Abstract

backgroundProgress of cholangitis to cholangiosepsis is a frequent observation in patients with secondary sclerosing cholangitis in critically ill patients (SSC-CIP). Adequate biliary drainage may reduce episodes of cholangiosepsis and therefore stabilize liver function and improve survival. The primary objective of the BISCIT study is to demonstrate that scheduled biliary interventions will reduce incidence of cholangiosepsis, liver transplantation, or death in patients with SSC-CIP.

methodsA total of 104 patients will be randomized at ten study sites. Patients with SSC-CIP, confirmed by endoscopic retrograde cholangiography (ERC), will be randomized 1:1 either in the intervention group which will be treated with scheduled biliary interventions (i.e., therapeutic ERC) every 8 weeks for 6 months or in the control group which will receive standard of care. The randomization will be stratified by center. The composite primary efficacy endpoint is defined as (1) occurrence of death, (2) necessity of liver transplantation, or (3) occurrence of cholangiosepsis within 6 months following randomization. DISCUSSION: Prospective evaluation of endoscopic treatment procedures is urgently needed to establish an evidence-based therapeutic treatment algorithm in SSC-CIP. A positive trial result could change the current standard of care for patients with SSC-CIP. The results of this study will be disseminated through presentations at international congresses, workshops, and peer-reviewed publications.

trial registrationThe trial was registered at ClinicalTrials.gov (NCT05396755, date of registration: May 31, 2022, last update: May 31, 2022).

Indexed as

Biliary Tract Surgical ProceduresCholangitis, SclerosingLiver TransplantationCritical IllnessHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicBiliary interventionsCholangiosepsisCritical ill patientsEndoscopic retrograde cholangiographyRandomized-controlled trialSecondary sclerosing cholangitis

Identifiers

PMID37004078
PMCPMC10067228
OpenAlexW4362469977

What OpenQuestion holds

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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.