Postoperative Biliary Fistula Prevention After Hepatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01469442
First received: July 4, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Non Cirrhotic Liver
Hepatectomy
Procedure: External Biliary duct stent in the bile duct by cystic way

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Postoperative biliary fistula [ Time Frame: 3 months after surgey ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Morbidity [ Time Frame: 3 months after surgey ] [ Designated as safety issue: Yes ]
    additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula

  • Mortality [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 304
Study Start Date: May 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: external biliary duct stent
The size of the external biliary duct stent depending of cystic duct size
Procedure: External Biliary duct stent in the bile duct by cystic way
The size of the external biliary duct stent depending of cystic duct size
No Intervention: without external biliary duct stent

Detailed Description:

After performing the hepatectomy and verification of hemostasis, patients were randomized (external biliary duct stent or not) by sealed envelopes. Systematic intraoperative test with methylene blue or air by the external biliary duct stent (EBDS) will necessary for all patients. Intra-abdominal drainage or not and type will be at the discretion of the surgeon. The EBDS will be left open for the first 7 postoperative days and then clamped. The EBDS will be removed during a consultation 5 weeks after surgery. Both groups of patients will be reviewed at 3 months after surgery, it will be noted at this point the possible complications related to the presence of EBDS (leakage from the drain, drop..). If patients are hospitalized more than five weeks, the study will stop at their consultation three months or the day of the consultation where the DTC is removed if it is still present at 3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged over 18 years
  • Subject has given his informed consent and signed consent
  • Topic affiliated with a social security system
  • Hepatectomy at least 2 segments of liver parenchyma for a benign or malignant disease by laparotomy
  • Not cirrhotic liver

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469442

Contacts
Contact: Fabrice MUSCARI, PI 05 61 32 27 41 ext 33 muscari.f@chu-toulouse.fr
Contact: Bertrand SUC, Investigator 05 61 32 27 41 ext 33 suc.b@chu-toulouse.fr

Locations
France
CHU Recruiting
Amiens, France, 80054
Contact: Jean Marc REGIMBEAU, Pr    03 22 66 79 ext 33    regimbeau.jean-marc@chu-amiens.fr   
Hotel Dieu Recruiting
Clermont Ferrand, France, 63003
Contact: emmanuel Buc, Dr    04 73 75 05 04. ext 33    ebuc@chu-clermontferrand.fr   
Sub-Investigator: Jacques Chipponi, Pr         
Hôpital beaujon Recruiting
Clichy, France, 92118
Contact: Jacques Belghiti, Pr    0140875058 ext 33    jacques.belguiti@bjn.aphp.fr   
Hôpital Claude Huriez Not yet recruiting
Lille, France, 59037
Contact: Emmanuel Boleslawski, Dr    0320444331 ext 33    emmanuel.boleslawski@CHRU-LILLE.FR   
Sub-Investigator: François René Pruvot, Pr         
Institut Paoli Calmettes Not yet recruiting
Marseille, France, 13273
Contact: Jean Delpero, Dr    04 91 22 36 60 ext 33    jrdelpero@numericable.fr   
CHU la conception Not yet recruiting
Marseille, France, 13385
Contact: Jean Hardwigsen, Pr    0491383658 ext 33    jean.hardwigsen@mail.ap-hm.fr   
Hôpital St Eloi Not yet recruiting
Montpellier, France, 34295
Contact: Francis Navarro, Pr    0467337097 ext 33    f-navarro@chu-montpellier.fr   
Hotel Dieu Not yet recruiting
Nantes, France, 44093
Contact: sylvie metairie, Dr    02 40 08 30 22 ext 33    Sylvie.metairie@chu-nantes.fr   
Sub-Investigator: paul antoine Lehur, Pr         
Hôpital Saint Antoine Suspended
Paris, France, 75012
hôpital Haute Pierre Recruiting
Strasbourg, France, 67098
Contact: Patrick Pessaux, Pr    03 88 12 72 59 ext 33    Patrick.pessaux@chru-strasbourg.fr   
Sub-Investigator: jaeck Daniel, Pr         
Toulouse Purpan Recruiting
Toulouse, France, 31000
Contact: Fabrice MUSCARI, Dr    05 61 32 27 41 ext 33    muscari.f@chu-toulouse.fr   
Contact: Bertrand SUC, Pr    05 61 32 27 41 ext 33    suc.b@chu-toulouse.fr   
Principal Investigator: Fabrice MUSCARI, Dr         
Sub-Investigator: Bertrand SUC, Pr         
Hôpital Paul Brousse Recruiting
Villejuif, France, 94804
Contact: Eric VIBERT, Dr    01 45 59 30 28 ext 33    eric.vibert@pbr.aphp.fr   
Sub-Investigator: denis CASTAING, Pr         
Sponsors and Collaborators
University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01469442     History of Changes
Other Study ID Numbers: 08 114 01
Study First Received: July 4, 2011
Last Updated: June 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Biliary fistula
prevention
hepatectomy
external stent
Hepatectomy of more 2 segments
Not emergency or laparoscopy surgery

Additional relevant MeSH terms:
Biliary Fistula
Fistula
Digestive System Fistula
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 26, 2014