Clinical trial NCT01469442: Postoperative Biliary Fistula Prevention After Hepatectomy
Official title: Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatectomy
Keywords: Biliary fistula
prevention
hepatectomy
external stent
Hepatectomy of more 2 segments
Not emergency or laparoscopy surgery
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Postoperative biliary fistula
timeFrame: 3 months after surgey
Secondary outcomes:
measure: Morbidity
timeFrame: 3 months after surgey
measure: Mortality
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Clermont Ferrand
country: France
facility: Hotel Dieu
city: Clichy
country: France
facility: Hôpital beaujon
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Marseille
country: France
facility: CHU la conception
city: Montpellier
country: France
facility: Hôpital St Eloi
city: Nantes
country: France
facility: Hotel Dieu
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Strasbourg
country: France
facility: hôpital Haute Pierre
city: Toulouse
country: France
facility: Toulouse Purpan
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
affiliation: University Hospital, Toulouse
name: Fabrice MUSCARI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.