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Postoperative Biliary Fistula Prevention After Hepatectomy

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ClinicalTrials.gov Identifier: NCT01469442
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Hepatectomy Procedure: External Biliary duct stent in the bile duct by cystic way

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial
Study Start Date : May 2009
Primary Completion Date : September 2017
Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: external biliary duct stent
'External Biliary duct stent in the bile duct by cystic way'
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


Outcome Measures

Primary Outcome Measures :
  1. Postoperative biliary fistula [ Time Frame: 3 months after surgey ]
    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 :
  1. Morbidity [ Time Frame: 3 months after surgey ]
    additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula

  2. Mortality [ Time Frame: 3 months after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469442


Locations
France
CHU
Amiens, France, 80054
Hotel Dieu
Clermont Ferrand, France, 63003
Hôpital beaujon
Clichy, France, 92118
Hôpital Claude Huriez
Lille, France, 59037
Institut Paoli Calmettes
Marseille, France, 13273
CHU la conception
Marseille, France, 13385
Hôpital St Eloi
Montpellier, France, 34295
Hotel Dieu
Nantes, France, 44093
Hôpital Saint Antoine
Paris, France, 75012
hôpital Haute Pierre
Strasbourg, France, 67098
Toulouse Purpan
Toulouse, France, 31000
Hôpital Paul Brousse
Villejuif, France, 94804
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Fabrice MUSCARI, MD University Hospital, Toulouse
More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01469442     History of Changes
Other Study ID Numbers: 08 114 01
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Fistula
Biliary Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases