Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma
Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction.
The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate.
The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma.
Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial|
- Post-operative surgical complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection
- Other post-operative complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay
- Survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]Overall and disease-free survival at 1, 3, 5-year
- Recurrence rate of hepatocellular carcinoma [ Time Frame: 5 year ] [ Designated as safety issue: No ]Recurrence rate of hepatocellular carcinoma at 1,3,5 year
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Intermittent vascular inflow occlusion applied during liver resection
Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval
Other Name: Vascular inflow occlusion
No Intervention: Non-Pringle
No vascular inflow occlusion applied during liver resection
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759901
|Contact: Kit Fai Lee, MBBSfirstname.lastname@example.org|
|The Prince of Wales Hospital||Recruiting|
|Hong Kong SAR, China|
|Contact: Kit Fai Lee, MBBS 852-26321577 email@example.com|
|Principal Investigator: Kit Fai Lee, MBBS|
|Principal Investigator:||Kit Fai Lee, MBBS||Clinical Associate Professor (honorary)|