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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.
Bile leakage (BL) is the most frequent complication after liver resection leading to the need of interventional drainage, endoscopic retrograde cholangio pancreatography (ERCP) or even reoperation. Strategies leading to a reduction of the rate of this complication are valuable. SMOFlipid 20% is a fat emulsion which is primary indicated for parenteral nutrition. Because of its fatty content this solution is white. This allows the clear intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct. Consequently, open bile ducts can be sutured preventing the postoperative development of BL. If the rate of bile leakages can be reduced, resources for interventions and relaparotomy will be saved. This study is to investigate intraoperative administration of SMOFlipid 20% in terms of prevention of BL within 30 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Intervention (treatment) | Experimental | Open bile ducts are identified by visual control of the liver resection surface combined with the direct injection in the cystic stump of 20-40ml of SMOFlipid 20% Fresenius Kabi Canada Ltd.; authorization number: 57231 (Swissmedic). SMOFlipid is a white oily emulsion containing soya oil and medium chain triglycerides as main active components, normally used as parenteral nutrition as complement for essential fat acids supplementation. In this study the "white" test (= the administration of SMOFlipid retrograde through the cystic duct) is made by injection of one or two 20cc syringes full of lipidic solution (SMOFlipid 20%) in the cystic stump, directing the flow to the intrahepatic ducts. Residual fat emulsion is washed out from the biliary tract by a low pressure infusion of 20 to 50 ml of saline solution. |
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| Control Intervention | No Intervention | Open bile ducts are identified in the control group by visual control of the liver resection surface combined with the use of white gauzes (standard procedure) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "white" test" (= the administration of SMOFlipid retrograde through the cystic duct) | Drug | "white" test" (= the administration of SMOFlipid retrograde through the cystic duct) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulia Manzini, Dr. med. | Contact | +41-62-8389734 | giulia.manzini@ksa.ch |
| Name | Affiliation | Role |
|---|---|---|
| Giulia Manzini, Dr. med. | Cantonal Hospital of Aarau, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral Surgery, Cantonal Hospital of Aarau | Recruiting | Aarau | 5001 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34326053 | Derived | Cristaudi A, Tarantino I, Scheiwiller A, Wiencierz A, Majno-Hurst P, Schmied BM, Metzger J, Hartel M, Kremer M, Manzini G. 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: study protocol for a randomised controlled multicentric superiority trial (BiLe-Trial). BMJ Open. 2021 Jul 29;11(7):e049449. doi: 10.1136/bmjopen-2021-049449. |
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Prospective randomized, controlled, observer and patient blinded multicentric (4 centres) superiority trial with 2 parallel study groups
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Patients, care providers and outcome assessors are blinded, the surgical team is not blinded.
| within 30 days postoperative |
| In-hospital mortality other than related to the bile leakage | In-hospital mortality other than related to the bile leakage | within 30 days postoperative |
| In-Hospital morbidity other than related to the bile leakage | In-Hospital morbidity other than related to the bile leakage | within 30 days postoperative |
| Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no) | Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no) | within 30 days postoperative |
| Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no) | Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no) | within 30 days postoperative |
| Interventional drainage (yes/no) | Interventional drainage (yes/no) | within 30 days postoperative |
| Re-operation (yes/no) | Re-operation (yes/no) | within 30 days postoperative |
| Intensive care unit (ICU) stay (in days) | Intensive care unit (ICU) stay (in days) | within 30 days postoperative |
| Total hospital stay (in days) | Total hospital stay (in days) | within 30 days postoperative |
| Clarunis Basel, Universitäres Bauchzentrum Basel | Recruiting | Basel | 4031 | Switzerland |
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| Kantonsspital Luzern | Recruiting | Lucerne | 6004 | Switzerland |
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| Ospedale Regionale di Lugano | Recruiting | Lugano | 6900 | Switzerland |
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| Kantonsspital St. Gallen | Recruiting | Sankt Gallen | 9001 | Switzerland |
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