Study on Clinical Outcome of Vascular Inflow Occlusion in Open Liver Resection
Recruitment status was Active, not recruiting
This study aims to evaluate whether applying inflow vascular occlusion in modern liver resection is associated with better clinical outcome.
Eligible patients are randomly assigned to the two surgical techniques: with or without the application of inflow vascular occlusion.
Patients outcome including liver function recovery, operative time and blood loss are compared.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Liver Resection With or Without Vascular Inflow Occlusion: a Randomized Control Trial|
- Operative blood loss [ Time Frame: From skin incision to completion of operation ] [ Designated as safety issue: Yes ]
- Operative time [ Time Frame: From skin incision to completion of operation ] [ Designated as safety issue: No ]
- Operative morbidity and mortality [ Time Frame: From date of operation to 30-day after operation ] [ Designated as safety issue: Yes ]
- Recovery of liver function [ Time Frame: From date of operation to date of discharge ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||August 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Intermittent clamp group
Procedure: Intermittent Pringle maneuver
Pringle maneuver is performed by isolation of the hepatoduodenal ligament which is then encircled and occluded with atraumatic vascular clamp. The clamp is applied for 15 minutes followed by unclamping for 5 minutes and repeated till end of liver transection. Limits of clamp cycle: 3 cycles for cirrhotic liver; 4 cycles for non-cirrhotic liver.
No Intervention: 2
No clamp group
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730743
|Prince of Wales Hospital|
|Hong Kong, China|
|Principal Investigator:||Kit-fai Lee, MBBS||Departement of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong|