White Test in Intra-operative Detection of Donor Biliary Leak in LDLTx.
Condition: Bile Leak
Study type: Interventional

Summary: 
      Biliary leak is a common complication after partial liver resection in living donor liver
      transplant. It debases the quality of the postoperative course and affects morbidity and
      mortality. Detecting and localizing sites of biliary leak intraoperatively through bile
      leakage testing is important as it helps in detection of bile leaking points on the cut
      surface and decrease post-operative bile leak.

      In this study we will assess the efficacy and sensitivity of using White test in comparison
      to conventional saline test in detecting intra operative bile leakage in liver donor.

      The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content
      of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition,
      for localization of bile leakage. The use of fat emulsion in bile leakage tests does not
      require special equipment, contaminate the wound, cause allergic reaction or damage the bile
      duct and surrounding tissues.
    

Detailed description: 
      Postoperative bile leakage is one of the commonest causes of sepsis and liver failure after
      liver resection in liver donor [ Yamashita YI et al, 2001 ] [ Langer D et al, 2011 ].Various
      studies have showed that the incidence of postoperative bile leakage after liver resection
      ranges from 3 to 27% [ Erdogan D et al, 2008 ] [ Ishii H et al, 2011 ].

      The timely detection and repair of intraoperative bile leakage is extremely important, but
      small leakage points are often difficult to detect [ Liu Z et al, 2012 ]. There are different
      methods for detecting and or preventing bile leakage after partial liver resection, including
      bile leakage tests, which detect open bile duct stumps on the resection surface through
      increasing fluid pressure within the duct [ Lo CM et al, 1998 ].

      The conventional intraoperative saline test, which involves injecting an isotonic sodium
      chloride solution through the cystic duct, has been used for detection of leaking points from
      the transected liver surface [ Ijichi M et al, 2000 ]. One of the main problems in using the
      conventional bile leakage test is that the isotonic sodium chloride solution is a transparent
      solution. Therefore, it is hard to detect the point of bile leakage. A previous randomized
      study stated that there is no advantage to using the isotonic sodium chloride solution for
      the bile leakage test during liver resection [ Ijichi M et al, 2000 ].

      During the past decade, several bile leak tests have been proposed, with none gaining wide
      acceptance. The intraductal injection of saline is a low-cost and reproducible technique, but
      the transparent solution makes this technique inadequate for detecting small ducts. The
      injection of dye solutions (e.g. methylene blue and indocyanine green) has been recommended.
      However, these solutions need to be dense in order to allow the visualization of the leak
      site. The related disadvantages of this approach include the following: 1) the indelible
      coloration of the transection surface, which can mask additional small open ducts, 2) the
      impossibility to wash out the staining and, consequently, 3) potential reduced sensitivity
      for the detection of leak with repeated tests. Some centres have reported the saturation of
      the cut surface of the liver with hydrogen peroxide to detect bile leaks, however this
      practice comes with a potential risk of expansion air embolism via open hepatic veins.

      The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content
      of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition,
      for localization of bile leakage (Morris-Stiff G et al., 2009). The use of fat emulsion in
      bile leakage tests does not require special equipment, contaminate the wound, cause allergic
      reaction or damage the bile duct and surrounding tissues. It can easily be repeated the
      number of times necessary to detect and close all leakage points, can pinpoint even small
      leaks and is inexpensive. This technique is easier to perform than fluorescent imaging, and
      is more sensitive and reliable compared with saline bile leakage test used alone (Leelawat K
      et al., 2012; Kaibori M et al., 2011).

      Recently, intraoperative application of the White test has been demonstrated to reduce the
      incidence of postoperative bile leakage [ Li J et al, 2009 ] [ Nadalin S et al, 2008 ]. In
      this technique, bile leakage sites on the transected liver surface are noted by injecting a
      fat emulsion solution through the cystic duct. The previous prospective observational studies
      suggested that the fat emulsion solution used in the White test is easily recognized,
      innocuous and harmeless to the tissues, and can be easily removed without misleading tissue
      staining [ Li J et al, 2009 ] [ Nadalin S et al, 2008 ]. Therefore, this prospective study
      will assess whether the White test is better than the conventional saline test for the
      intraoperative detection of bile leakage and better prevention of post-operative bile leakage
      in partial resection in living donor liver transplant.
    

Intervention name(s): The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage.; Saline test (routine test)
Intervention type(s): Procedure; Procedure
Intervention description(s): The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage.; The conventional intra-operative saline test, which involves injecting an isotonic sodium chloride solution through the cystic duct, has been used for detection of leaking points from the transected liver surface.
Intervention MeSH terms: SMOFlipid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Non randomized controlled Interventional trial Compare the study group with a historical cohort.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: White test, Donor, liver transplantation, living donor