Postoperative Biliary Fistula Prevention After Hepatectomy

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT01469442

Collaborator

(none)

304

Enrollment

Locations

Arms

100

Duration (Months)

25.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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	Phase
Hepatectomy	Procedure: External Biliary duct stent in the bile duct by cystic way	N/A

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

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 1, 2009

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

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

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

Postoperative biliary fistula [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

Morbidity [3 months after surgey]
additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula
Mortality [3 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	CHU	Amiens	France	80054
2	Hotel Dieu	Clermont Ferrand	France	63003
3	Hôpital beaujon	Clichy	France	92118
4	Hôpital Claude Huriez	Lille	France	59037
5	Institut Paoli Calmettes	Marseille	France	13273
6	CHU la conception	Marseille	France	13385
7	Hôpital St Eloi	Montpellier	France	34295
8	Hotel Dieu	Nantes	France	44093
9	Hôpital Saint Antoine	Paris	France	75012
10	hôpital Haute Pierre	Strasbourg	France	67098
11	Toulouse Purpan	Toulouse	France	31000
12	Hôpital Paul Brousse	Villejuif	France	94804