Bile Leakage Clinical Trial
— BiLeOfficial title:
Diagnostic Role of the "White Test" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection- A Randomized Controlled Multicentric Superiority Trial- The BiLe-Trial (Bile Leakage Trial)
Bile leakage (BL) is the most frequent complication after liver resection. This study is to investigate the role of intraoperative administration of SMOFlipid 20% (fat emulsion which allows intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct) in terms of prevention of postoperative BL within 30 days after surgery.
| Status | Recruiting |
| Enrollment | 210 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients who will receive an anatomical resection of two or more liver segments for any reason with simultaneous cholecystectomy in elective Setting - Patients who will receive an anatomical resection of two or more liver segments for any reason which already had a cholecystectomy if intraoperatively the cystic stump can be identified and opened - Ability of subject to understand character and individual consequences of the clinical Trial - Informed consent documented by signature Exclusion Criteria: - Previous cholecystectomy if intraoperative it is not possible to identify the cystic stump - Intraoperative hepatico-jejunostomy - Hypersensitivity to fish-, egg-, soybean or peanut protein or to any of the active ingredients or excipients - Immunosuppression, pregnancy - Emergency liver resection because of traumatic liver rupture - Enrolment of the investigator, his/her family members, employees and other dependent persons |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department of Visceral Surgery, Cantonal Hospital of Aarau | Aarau | |
| Switzerland | Clarunis Basel, Universitäres Bauchzentrum Basel | Basel | |
| Switzerland | Ospedale Regionale di Lugano | Lugano | |
| Switzerland | Kantonsspital Luzern | Luzern | |
| Switzerland | Kantonsspital St. Gallen | St. Gallen |
| Lead Sponsor | Collaborator |
|---|---|
| Giulia Manzini |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | rate of postoperative bile leakage | Comparison of the rate of postoperative bile leakage in the control and in the intervention group. This is a binary endpoint defined by the presence or absence of the bile leakage (yes or no). Bile leakage is defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3. | within 30 days postoperative | |
| Secondary | Severity of the bile leakage (Grade A, B or C according to the definition by Koch et al). | The severity of bile leakage is classified according to its impact on patients´ clinical management. Grade A bile leakage causes no change in patients' clinical management. A Grade B bile leakage requires active therapeutic intervention but is manageable without relaparotomy, whereas in Grade C bile leakage relaparotomy is required. | within 30 days postoperative | |
| Secondary | In-hospital mortality other than related to the bile leakage | In-hospital mortality other than related to the bile leakage | within 30 days postoperative | |
| Secondary | In-Hospital morbidity other than related to the bile leakage | In-Hospital morbidity other than related to the bile leakage | within 30 days postoperative | |
| Secondary | Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no) | Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no) | within 30 days postoperative | |
| Secondary | Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no) | Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no) | within 30 days postoperative | |
| Secondary | Interventional drainage (yes/no) | Interventional drainage (yes/no) | within 30 days postoperative | |
| Secondary | Re-operation (yes/no) | Re-operation (yes/no) | within 30 days postoperative | |
| Secondary | Intensive care unit (ICU) stay (in days) | Intensive care unit (ICU) stay (in days) | within 30 days postoperative | |
| Secondary | Total hospital stay (in days) | Total hospital stay (in days) | within 30 days postoperative |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01960712 -
The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
|
N/A |