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 (BiLe -Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: "white" test" (= the administration of SMOFlipid retrograde through the cystic duct).
- Who it may be relevant to
- Registry conditions: Bile Leakage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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
- Drug "white" test" (= the administration of SMOFlipid retrograde through the cystic duct)
"white" test" (= the administration of SMOFlipid retrograde through the cystic duct)
Primary outcome measures
- rate of postoperative bile leakage [Time frame: within 30 days postoperative]
Secondary outcome measures (9)
- Severity of the bile leakage (Grade A, B or C according to the definition by Koch et al). [Time frame: within 30 days postoperative]
- In-hospital mortality other than related to the bile leakage [Time frame: within 30 days postoperative]
- In-Hospital morbidity other than related to the bile leakage [Time frame: within 30 days postoperative]
- Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no) [Time frame: within 30 days postoperative]
- Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no) [Time frame: within 30 days postoperative]
- Interventional drainage (yes/no) [Time frame: within 30 days postoperative]
- Re-operation (yes/no) [Time frame: within 30 days postoperative]
- Intensive care unit (ICU) stay (in days) [Time frame: within 30 days postoperative]
- Total hospital stay (in days) [Time frame: within 30 days postoperative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Switzerland · 5 centers
- Department of Visceral Surgery, Cantonal Hospital of Aarau — Aarau
- Clarunis Basel, Universitäres Bauchzentrum Basel — Basel
- Kantonsspital Luzern — Lucerne
- Ospedale Regionale di Lugano — Lugano
- Kantonsspital St. Gallen — Sankt Gallen
Publications
- 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. 2 PMID 34326053
Identifiers
NCT: NCT04523701 · 2020-02081; ex20Manzini