Bile Leakage
Conditions
Keywords
Liver resection, SMOFlipid 20%, White Test
Brief summary
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.
Detailed description
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.
Interventions
DRUGwhite test (= the administration of SMOFlipid retrograde through the cystic duct)
white test (= the administration of SMOFlipid retrograde through the cystic duct)
Sponsors
Giulia Manzini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patients, care providers and outcome assessors are blinded, the surgical team is not blinded.
Intervention model description
Prospective randomized, controlled, observer and patient blinded multicentric (4 centres) superiority trial with 2 parallel study groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of postoperative bile leakage | within 30 days postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality other than related to the bile leakage | within 30 days postoperative | In-hospital mortality other than related to the bile leakage |
| In-Hospital morbidity other than related to the bile leakage | within 30 days postoperative | In-Hospital morbidity other than related to the bile leakage |
| Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no) | within 30 days postoperative | Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no) |
| Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no) | within 30 days postoperative | Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no) |
| Severity of the bile leakage (Grade A, B or C according to the definition by Koch et al). | within 30 days postoperative | 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. |
| Re-operation (yes/no) | within 30 days postoperative | Re-operation (yes/no) |
| Intensive care unit (ICU) stay (in days) | within 30 days postoperative | Intensive care unit (ICU) stay (in days) |
| Total hospital stay (in days) | within 30 days postoperative | Total hospital stay (in days) |
| Interventional drainage (yes/no) | within 30 days postoperative | Interventional drainage (yes/no) |
Countries
Switzerland
Contacts
Primary ContactGiulia Manzini, Dr. med.
Outcome results
None listed