- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04265157
Hepato-duodenal Ligament Occlusion and Classic Technique in Liver Transplant
February 9, 2020 updated by: Ahmed mahmoud mohammed elkoussy, Assiut University
Hepato-duodenal Ligament Occlusion Versus Classic Technique During Recipient Hepatectomy in Liver Transplantation
Liver transplantation was historically associated with massive blood loss.
Many factors have contributed to the decline in bleeding and transfusion in the past two decades including refinement of surgical techniques, anesthetics management and the use of point of care guided goal-directed hemostatic therapies.
Increasing awareness of the adverse associations of allogenic transfusion has driven the quest for transfusion-free transplantation.
Pre-operative management of preoperative anemia and targeted correction of coagulopathy is done to decrease blood transfusion.
Liver transplantation is associated with the potential for massive operative blood loss, which has been recognized as one of the main causes of morbidity and mortality after liver transplantation.
Therefore, a fine surgical procedure to reduce intraoperative hemorrhage is necessary for favorable outcomes of liver transplantation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We will included in the study all patients accepted for Living Donor LiverTransplantation (LDLT) according to hospital protocol
Description
Inclusion Criteria:
- All patients undergoing Living Donor Liver Transplantation accepted according to hospital protocol
- All patients with liver Cirrhosis who have Porto systemic collaterals based on ct angiography
Exclusion Criteria:
- Acute fulminant liver failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Early occlusion of hepatoduodenal ligament
Early occlusion of hepatoduodenal ligament during mobilization of the liver of the recipient by using portal vein clamp or occlusive temporary bands.
|
Occlusion of hepatoduodenal ligament by clamp or occlusive bands
|
|
classical occlusion of hepatoduodenal ligament
classical occlusion of hepatoduodenal ligament after mobilization of the liver of the recipient immediately before explantation by suing of portal vein clamp
|
Occlusion of hepatoduodenal ligament by clamp or occlusive bands
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The amount of intraoperative blood loss measure by Cubic Cm
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Donohue CI, Mallett SV. Reducing transfusion requirements in liver transplantation. World J Transplant. 2015 Dec 24;5(4):165-82. doi: 10.5500/wjt.v5.i4.165.
- Park YK, Kim BW, Wang HJ, Xu W. Usefulness of the Pinch-Burn-Cut (PBC) technique for recipient hepatectomy in liver transplantation. Korean J Hepatobiliary Pancreat Surg. 2012 Feb;16(1):13-6. doi: 10.14701/kjhbps.2012.16.1.13. Epub 2012 Feb 29.
- Houben P, Khajeh E, Hinz U, Knebel P, Diener MK, Mehrabi A. SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial. Trials. 2018 Jul 16;19(1):380. doi: 10.1186/s13063-018-2778-1.
- Choi JU, Hwang S, Ahn CS, Moon DB, Ha TY, Kim KH, Song GW, Jung DH, Park GC, Lee SG. Prolonged occlusion of the hepatoduodenal ligament to reduce risk of bleeding and tumor spread during recipient hepatectomy for living donor liver transplantation. Ann Hepatobiliary Pancreat Surg. 2019 Feb;23(1):61-64. doi: 10.14701/ahbps.2019.23.1.61. Epub 2019 Feb 28.
- Lee KF, Wong J, Cheung SYS, Chong CCN, Hui JWY, Leung VYF, Yu SCH, Lai PBS. Does Intermittent Pringle Maneuver Increase Postoperative Complications After Hepatectomy for Hepatocellular Carcinoma? A Randomized Controlled Trial. World J Surg. 2018 Oct;42(10):3302-3311. doi: 10.1007/s00268-018-4637-3.
- Cleland S, Corredor C, Ye JJ, Srinivas C, McCluskey SA. Massive haemorrhage in liver transplantation: Consequences, prediction and management. World J Transplant. 2016 Jun 24;6(2):291-305. doi: 10.5500/wjt.v6.i2.291.
- Yoon JU, Byeon GJ, Park JY, Yoon SH, Ryu JH, Ri HS. Bloodless living donor liver transplantation: Risk factors, outcomes, and diagnostic predictors. Medicine (Baltimore). 2018 Dec;97(50):e13581. doi: 10.1097/MD.0000000000013581.
- Kornberg A, Witt U, Kornberg J, Ceyhan GO, Mueller K, Friess H, Thrum K. Prognostic Impact of Intraoperative Blood Loss in Liver Transplant Patients with Advanced Hepatocellular Carcinoma. Anticancer Res. 2016 Oct;36(10):5355-5364. doi: 10.21873/anticanres.11109. Epub 2016 Oct 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2020
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
February 9, 2020
First Posted (Actual)
February 11, 2020
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 9, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- LDLT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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