Postoperative Biliary Fistula Prevention After Hepatectomy

Hepatectomy Clinical Trial

Official title:

Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469442
• Other study ID #: 08 114 01
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: September 2017

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Fistula
• Fistula
• Hepatectomy

Intervention

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

Locations

Country	Name	City	State
France	CHU	Amiens
France	Hotel Dieu	Clermont Ferrand
France	Hôpital beaujon	Clichy
France	Hôpital Claude Huriez	Lille
France	CHU la conception	Marseille
France	Institut Paoli Calmettes	Marseille
France	Hôpital St Eloi	Montpellier
France	Hotel Dieu	Nantes
France	Hôpital Saint Antoine	Paris
France	hôpital Haute Pierre	Strasbourg
France	Toulouse Purpan	Toulouse
France	Hôpital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & 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 tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morbidity	additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula	3 months after surgey
Secondary	Mortality		3 months after surgery