Bile LeakLDLTxNCT04451447
White Test in Intra-operative Detection of Donor Biliary Leak in LDLTx.
A study testing The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage. and Saline test (routine test) in people with Bile Leak, run by Amr Abdelaal at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bile Leak
- What is being tested?
- The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage. and Saline test (routine test)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2019to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Intra operative vascular or biliary complication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Sensitivity of White Test Versus Conventional Saline Test in Minimizing Biliary Leak in Partial Liver Resection in Living Donor Liver Transplant
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.
Read the 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.
- Conditions
- Bile Leak
- Being tested
- The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage., Saline test (routine test)
- Keywords
- White test, Donor, liver transplantation, living donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage.Procedure or surgery
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.
Saline test (routine test)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| white test arm | Experimental | 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. Receives: Procedure: The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage. |
| Saline test arm | Other | 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. Receives: Procedure: Saline test (routine test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative detection of bile leak points
Detection and suturing of bile leak points
Measured: Immediate Intra-operative
Secondary outcomes (2)
post-operative bile leak
post-operative bile leak - Biloma
Measured: Early post-operative (one month)
Surgical site infection
Infected biloma
Measured: Early post-operative (one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start20 Mar 2019
- Primary completion15 Jun 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non randomized controlled Interventional trial Compare the study group with a historical cohort.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amr Abdelaal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amr Abdelaal, Ain Shams University
- Investigators
- amr abdelaal, prof, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451447
- Sponsor's protocol ID
- White test in LDLTx
- Acronym
- LDLTx
- Status last verified
- Jun 2020
- First submitted
- 27 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Sensitivity of White Test Versus Conventional Saline Test in Minimizing Biliary Leak in Partial Liver Resection in Living Donor Liver Transplant
- ClinicalTrials.gov ID
- NCT04451447
- Acronym / sponsor ID
- LDLTx / White test in LDLTx
- Conditions
- Bile Leak
- Keywords
- White test, Donor, liver transplantation, living donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amr AbdelaalUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non randomized controlled Interventional trial Compare the study group with a historical cohort.
| Arm | Type | Receives |
|---|---|---|
| white test arm | Experimental | Procedure: The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage.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. |
| Saline test arm | Other | Procedure: Saline test (routine test)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Intra operative vascular or biliary complication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage.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. | Procedure or surgery | white test arm |
| Saline test (routine test)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. | Procedure or surgery | Saline test arm |
Primary outcome
Intra-operative detection of bile leak points
Time frame: Immediate Intra-operative
Detection and suturing of bile leak points
2 secondary outcomes
post-operative bile leak
Time frame: Early post-operative (one month)
Surgical site infection
Time frame: Early post-operative (one month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
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Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
amr abdelaal, prof principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage. and Saline test (routine test) in people with Bile Leak, run by Amr Abdelaal at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative detection of bile leak points (time frame: Immediate Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.