HepatectomyVPINCT01469442
Postoperative Biliary Fistula Prevention After Hepatectomy
A study testing External Biliary duct stent in the bile duct by cystic way in people with Hepatectomy, run by University Hospital, Toulouse at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy
- What is being tested?
- External Biliary duct stent in the bile duct by cystic way
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 12 sitesFrance
- Study dates
- May 2009to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Preoperative jaundice (total bilirubin> 30 micromol / l)
- Presence of preoperative biliary drainage
- Patients requiring the installation of a drain transcystic during the operation
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CHU
Amiens, 80054
Hotel Dieu
Clermont-Ferrand, 63003
Hôpital beaujon
Clichy, France, 92118
Hôpital Claude Huriez
Lille, 59037
Institut Paoli Calmettes
Marseille, 13273
CHU la conception
Marseille, 13385
Hôpital St Eloi
Montpellier, 34295
Hotel Dieu
Nantes, 44093
Hôpital Saint Antoine
Paris, 75012
hôpital Haute Pierre
Strasbourg, 67098
Toulouse Purpan
Toulouse, France, 31000
Hôpital Paul Brousse
Villejuif, 94804
About this study
Official title: Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial
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.
Read more
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.
Read the 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.
- Conditions
- Hepatectomy
- Being tested
- External Biliary duct stent in the bile duct by cystic way
- Keywords
- Biliary fistula, prevention, hepatectomy, external stent, Hepatectomy of more 2 segments, Not emergency or laparoscopy surgery
- Medical subject headings
- Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Biliary duct stent in the bile duct by cystic wayProcedure or surgery
The size of the external biliary duct stent depending of cystic duct size
| Study group | Role | What they receive |
|---|---|---|
| external biliary duct stent | Experimental | 'External Biliary duct stent in the bile duct by cystic way' Receives: Procedure: External Biliary duct stent in the bile duct by cystic way |
| without external biliary duct stent | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after surgey
Secondary outcomes (2)
Morbidity
additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula
Measured: 3 months after surgey
Mortality
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startMay 2009
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice MUSCARI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469442
- Sponsor's protocol ID
- 08 114 01
- Other IDs
- 2008-A01268-47
- Acronym
- VPI
- Status last verified
- Mar 2026
- First submitted
- 4 Jul 2011
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31916605
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT01469442
- Acronym / sponsor ID
- VPI / 08 114 01
- Conditions
- Hepatectomy
- Keywords
- Biliary fistula, prevention, hepatectomy, external stent, Hepatectomy of more 2 segments, Not emergency or laparoscopy surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| external biliary duct stent | Experimental | Procedure: External Biliary duct stent in the bile duct by cystic way'External Biliary duct stent in the bile duct by cystic way' |
| without external biliary duct stent | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Surgery made in emergency
- Surgery by laparoscopy
- Need to draw up a bilic-digestive anastomosis
- Liver cirrhosis
- History of cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Biliary duct stent in the bile duct by cystic wayThe size of the external biliary duct stent depending of cystic duct size | Procedure or surgery | external biliary duct stent |
Primary outcome
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).
2 secondary outcomes
Morbidity
Time frame: 3 months after surgey
Mortality
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Results publication: PubMed 31916605Maulat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice MUSCARI, MD principal investigator
University Hospital, Toulouse
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Biliary duct stent in the bile duct by cystic way in people with Hepatectomy, run by University Hospital, Toulouse at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative biliary fistula (time frame: 3 months after surgey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01469442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.