Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT01759901|
Recruitment Status : Unknown
Verified February 2015 by Cheung Yue Sun, Chinese University of Hong Kong.
Recruitment status was: Recruiting
First Posted : January 3, 2013
Last Update Posted : February 4, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: Pringle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||February 2016|
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
- Post-operative surgical complications [ Time Frame: 1 month ]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 ]post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay
- Survival [ Time Frame: 5 year ]Overall and disease-free survival at 1, 3, 5-year
- Recurrence rate of hepatocellular carcinoma [ Time Frame: 5 year ]Recurrence rate of hepatocellular carcinoma at 1,3,5 year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|