White test versus conventional saline test in detecting intraoperative bile leakage in liver resection

Naga, Mohamed Aboul; Sayed, Hatem; Mamdouh, Kamal

doi:10.4103/ejs.ejs_103_18

Cited by 1 publication

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“…As all existing studies describe the use of a sterile fat emulsion normally used for parenteral nutrition for the performance of the White test without giving the commercial name, with exception of the study by Nage et al 2018 13 where SMOFlipid20% is used, we decided to use the same fat emulsion.…”

Section: Methods and Analysismentioning

confidence: 99%

“…According to the majority of the published studies, we will use SMOFlipid20% diluted to a concentration of 5% similarly to the study by Naga et al . 13 The dilution will be done by adding intraoperatively to the 100 mL SMOFlipid20% 300 mL isotonic saline solution in order to obtain 400 mL of a 5% fat emulsion.…”

Section: Methods and Analysismentioning

confidence: 99%

“…Regarding the concentration of the solution, only 4 studies report this to be 5%, 7-9 13 the remaining studies describe only a 'sterile fat emulsion'. According to the majority of the published studies, we will use SMOF-lipid20% diluted to a concentration of 5% similarly to the study by Naga et al 13 The dilution will be done by adding intraoperatively to the 100 mL SMOFlipid20% 300 mL isotonic saline solution in order to obtain 400 mL of a 5% fat emulsion.…”

Section: Methods and Analysis Fat Emulsionmentioning

confidence: 99%

“…In 2018 Naga et al published a prospective randomised (not controlled) study comparing the white test (50 patients) with conventional saline test (50 patients) in detecting intraoperative bile leakage in liver resection. 13 To perform the white test, 10–20 mL of a 5% sterile fat emulsion (diluted SMOFlipid20%) was used. The postoperative course for all patients showed that 22 (44%) patients of the saline test group had bile leakage, but in the White test group, only four (8%) patients had leakage.…”

Section: Introductionmentioning

confidence: 99%

“…Several studies and meta-analyses [8][9][10][11][12][13] show the superiority of the white test when compared with no bile leakage test as well as with leakage test with saline solution. In all studies, no complications derived from the performance of the white test are described.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

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)

et al. 2021

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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

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Section: Methods and Analysismentioning

confidence: 99%

Section: Methods and Analysismentioning

confidence: 99%

Section: Methods and Analysis Fat Emulsionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%