Infrahepatic Inferior Vena Cava Clamping Versus Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping

Study Overview
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Brief Summary
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This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another equivalent group patients will be operated using SHVE and PTC.

Detailed Description
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Intraoperative blood loss is significantly associated with clinical outcomes of patients undergoing hepatectomy. There have been various hepatic vascular control techniques, including infrahepatic inferior vena cava clamping (IIVCC) and selective hepatic vascular exclusion (SHVE).The propose of this study is to compare these two surgical techniques combined with the portal triad clamping (PTC) in hepatic cirrhotic patients. All patients being performed hepatectomy at the center are scanned according to inclusion and exclusion criteria. After intraoperative exploration, patients are randomized into two interventional groups. PTC, IIVCC or SHVE is performed at the specified timepoint in liver parenchymal transection in two different groups. All data are collected prospectively.

Official Title
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A Prospective Randomized Controlled Trial to Compare Infrahepatic Inferior Vena Cava Clamping With Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping in Hepatectomy

Conditions
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Liver Neoplasms, Liver Cirrhosis

Intervention / Treatment
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* Procedure: Infrahepatic inferior vena cava clamping
* Procedure: Selective hepatic vascular exclusion
* Procedure: Portal triad clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: either male or female, older than 18 (include 18). tumors oppress or be in close proximity to one or more of major hepatic veins. the maximum diameter of tumor ≥ 5cm, number of lesions ≤ 3 and should be in same liver lobe if multiple lesions exit. preoperative liver function assessment: Child-Pugh classification is A or B. preoperative laboratory test: blood platlet count > 100×10^9/l, prothrombin activity > 60%. liver cirrhosis. Exclusion Criteria: contraindication for surgery,e.g.severe disorders of circulation, respiratory or renal system. extrahepatic metastasis in patients with malignancy or tumor invasion of portal vein, hepatic vein, bile duct or inferior vena cava. hepatectomy accompanied with other organs resection(e.g. bile duct, intestine, pancreas or stomach) regular hepatectomy. tumors located in the left lateral lobe of liver. previous hepatectomy. pregnancy or lactation. refusal to participate this trial.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IIVCC group<br>The portal triad and infrahepatic inferior vena cava are dissected and taped with a vessel loop, respectively. During liver parenchymal resection，portal triad and infrahepatic inferior vena cava clampings are performed at the specified transection depth from liver surface successively. | Procedure: Infrahepatic inferior vena cava clamping<br>* Infrahepatic inferior vena cava is clamped in hepatectomy.<br>* Other names: IIVCC;Procedure: Portal triad clamping<br>* Portal triad are clamped in hepatectomy.<br>* Other names: PTC;|
| Active Comparator: SHVE group<br>In this group, the portal triad clamping and selective hepatic vascular exclusion of major hepatic veins are used. Different major hepatic veins are occluded by clamping forcep depending on the site of tumors. The clamping timepoints are same as the IIVCC group. | Procedure: Selective hepatic vascular exclusion<br>* Selected major hepatic vein is clamped in hepatectomy.<br>* Other names: SHVE;Procedure: Portal triad clamping<br>* Portal triad are clamped in hepatectomy.<br>* Other names: PTC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | blood loss from incision to closure | Intraoperative period | 
| Normalized transection-related blood loss | Intraoperative blood loss normalized by transection surface area | Intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of infrahepatic inferior vena cava or selected hepatic vein dissection | Time cost of dissection | Intraoperative period | 
| Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure |  | Intraoperative period | 
| Drop of hemoglobin level |  | Drop of hemoglobin level will be measured during liver parenchymal transection period(neither the specific time point nor expected average could be given prospectively because of different surgical situations) | 
| Postrecovery of liver function | Liver function evaluation is composite of liver enzyme ，total bilirubin, prothrombin activity, etc. | postoperative days 1, 3, 5, 7 | 
| Postrecovery of renal function | Renal function evaluation is composite of blood urea nitrogen, creatinine, etc. | postoperative days 1, 3, 5, 7 | 
| Morbidity of postoperative complications |  | 90 days after surgery | 
| Postoperative mortality |  | 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Blood Loss, Haemorrhage, Vascular Control