Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A01268-47 | Other Identifier | French ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| external biliary duct stent | Experimental | 'External Biliary duct stent in the bile duct by cystic way' |
|
| without external biliary duct stent | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Biliary duct stent in the bile duct by cystic way | Procedure | The size of the external biliary duct stent depending of cystic duct size |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula | 3 months after surgey |
| Mortality | 3 months after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fabrice MUSCARI, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital beaujon | Clichy | France | 92118 | France | ||
| Toulouse Purpan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31916605 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001658 | Biliary Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Toulouse |
| France |
| 31000 |
| France |
| CHU | Amiens | 80054 | France |
| Hotel Dieu | Clermont-Ferrand | 63003 | France |
| Hôpital Claude Huriez | Lille | 59037 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| CHU la conception | Marseille | 13385 | France |
| Hôpital St Eloi | Montpellier | 34295 | France |
| Hotel Dieu | Nantes | 44093 | France |
| Hôpital Saint Antoine | Paris | 75012 | France |
| hôpital Haute Pierre | Strasbourg | 67098 | France |
| Hôpital Paul Brousse | Villejuif | 94804 | France |
| D013568 | Pathological Conditions, Signs and Symptoms |