Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Open Liver Resection With or Without Vascular Inflow Occlusion for Hepatocellular Carcinoma: a Randomized Controlled Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Pringle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 Child's A or B cirrhosis Exclusion Criteria: Informed consent not available Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, lipiodol-ethanol mixture injection or transarterial internal radiation Anticipation of portal vein resection Emergency hepatectomy Ruptured HCC Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver Anticipation of concomitant bowel or bile duct resection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pringle<br>Intermittent vascular inflow occlusion applied during liver resection | Procedure: Pringle<br>* Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval<br>* Other names: Vascular inflow occlusion;|
| No Intervention: Non-Pringle<br>No vascular inflow occlusion applied during liver resection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative surgical complications | 30-day morbidity after open liver resection, which includes ascites, pleural effusion, wound infection and intra-abdominal collection | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other post-operative complications | post-operative liver failure, post-op mortality, operative blood loss, duration of operation and hospital stay | 1 month | 
| Survival | Overall and disease-free survival at 1, 3, 5-year | 5 year | 
| Recurrence rate of hepatocellular carcinoma | Recurrence rate of hepatocellular carcinoma at 1,3,5 year | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatectomy, vascular inflow occlusion