NCT01469442

Brief Summary

Aim : Effect of external biliary duct stent after hepatectomy on the occurence of postoperative biliary fistula. Methods : French prospective multicenter randomized trial. Population study: Adult patients who underwent hepatectomy (\> 2 segments) on non-cirrhotic liver. Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a external biliary duct stent. With this hypothesis, the number of patients required to be equal to 152 per group for a total of 304 patients. Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma, biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat biliary fistula, during of hospital stay and biliary fistula. Follow up: A follow-up of patients 3 months after surgery for all patients. The planned total duration of the study is 3 years and 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

8.3 years

First QC Date

July 4, 2011

Last Update Submit

July 28, 2020

Conditions

Hepatectomy

Keywords

Biliary fistulapreventionhepatectomyexternal stentHepatectomy of more 2 segmentsNot emergency or laparoscopy surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative biliary fistula

    3 forms of diagnosis : bile in the intra-abdominal drainage; presence of an intra-abdominal collection of bile liquid (biloma); presence of an effusion of bile in the abdominal space (biliary peritonitis).

    3 months after surgey

Secondary Outcomes (2)

  • Morbidity

    3 months after surgey

  • Mortality

    3 months after surgery

Study Arms (2)

external biliary duct stent

EXPERIMENTAL

'External Biliary duct stent in the bile duct by cystic way'

Procedure: External Biliary duct stent in the bile duct by cystic way

without external biliary duct stent

NO INTERVENTION

Interventions

External Biliary duct stent in the bile duct by cystic wayPROCEDURE

The size of the external biliary duct stent depending of cystic duct size

external biliary duct stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has given his informed consent and signed consent
  • Hepatectomy at least 2 segments of liver parenchyma for a benign or malignant disease by laparotomy
  • Not cirrhotic liver

You may not qualify if:

  • Surgery made in emergency
  • Surgery by laparoscopy
  • Need to draw up a bilic-digestive anastomosis
  • Liver cirrhosis
  • History of cholecystectomy
  • Resection of less than 2 segments
  • Preoperative jaundice (total bilirubin\> 30 micromol / l)
  • Presence of preoperative biliary drainage
  • Patients requiring the installation of a drain transcystic during the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU

Amiens, 80054, France

Location

Hotel Dieu

Clermont-Ferrand, 63003, France

Location

Hôpital beaujon

Clichy, 92118, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHU la conception

Marseille, 13385, France

Location

Hôpital St Eloi

Montpellier, 34295, France

Location

Hotel Dieu

Nantes, 44093, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

hôpital Haute Pierre

Strasbourg, 67098, France

Location

Toulouse Purpan

Toulouse, 31000, France

Location

Hôpital Paul Brousse

Villejuif, 94804, France

Location

Related Publications (1)

  • Maulat C, Regimbeau JM, Buc E, Boleslawski E, Belghiti J, Hardwigsen J, Vibert E, Delpero JR, Tournay E, Arnaud C, Suc B, Pessaux P, Muscari F. Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial. Br J Surg. 2020 Jun;107(7):824-831. doi: 10.1002/bjs.11405. Epub 2020 Jan 9.

    PMID: 31916605RESULT

MeSH Terms

Conditions

Biliary Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Fabrice MUSCARI, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2011

First Posted

November 10, 2011

Study Start

May 1, 2009

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(12)