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)

IntroductionBile leakage is a frequent complication after liver resection associated with the need of interventional drainage, endoscopic retrograde cholangio pancreatography (ERCP) or reoperation. The intraoperative application of the white test could be a promising strategy to reduce the occurrence of bile leakages. Therefore, we propose to conduct the first multicentric randomised controlled trial with rate of postoperative bile leakage as primary endpoint with and without the white test.Methods and analysisThe Bile-Leakage Trial trial is an investigator-initiated randomised controlled, parallel group, double-blinded, multicentric, superiority trial in four Swiss centres. A total of 210 patients undergoing a resection of at least 2 liver segments will be randomly allocated intraoperatively to either the intervention (identification of open bile ducts with administration of 20–40 mL SMOFlipid5% in the bile tract) or the control group (identification with a white gauze on the liver resection surface).Primary outcome will be the comparison of the postoperative bile leakage rate in both groups within 30 days after liver resection, defined according to the classification of the International Study Group of Liver Surgery. Secondary outcomes will be operative and postoperative complication, including severity grade of the bile leakage, rate of ERCP, interventional drainage, morbidity, intensive care unit stay, and mortality.Ethics and disseminationThe cantonal ethics committees of all participating centres and Swissmedic approved the study. SMOFlipid20% consists of a mixture of oils, no side effects resulting from the intraoperative application of 20–40 mL in the biliary tract with consecutive enteral absorption are expected nor are side effects described in the literature. SMOFlipid20% will be diluted intraoperatively with isotonic saline solution to a concentration of 5%. The results of the BiLe-Trial will be submitted to a peer-reviewed journal regardless of the outcome. As this is an investigator-initiated trial, data are property of the sponsor investigator and can be obtained on request.Trial registration numberClinicaltrials.gov, ID: NCT04523701. Registered on 25 August 2020.Swiss National Clinical Trials Portal (SNCTP), ID: SNCTP000004200. Registered on 20 January 2021.Protocol versionV3.2_14-12-2020_clean.pdf

Bronchoscopic drainage with full personal protective equipment (PPE) saved a life of COVID-19 infected patient with ventilator associated pneumonic athelectasis from the Diamond Princess Cruise Ship

A 75 year-old American passenger was transferred to our hospital, infected in Diamond Princess, with pneumonia due to COVID-19 infection. At the beginning, he walked in but on day 4, he needed intubation and mechanical ventilation support because of worsening respiratory function due to wide-spread pneumonia. Despite the ventilation, his respiratory condition did not improve due to his left lower lobe atelectasis by an obstruction of left main bronchus. On day 9, interventional drainage of the major bronchus by disposable bronchoscopy was performed and built-up cast was removed by suctioning under the endoscopy. After the procedure, respiratory condition remarkably improved and he was extubated on day 14. COVID-19 infection with severe acute respiratory failure need mechanical ventilation support and if major airway obstruction was suspected, immediate interventional drainage may drastically change the patient clinical course and outcome.