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

Not Applicable

• Conditions: Liver Cirrhosis; Liver Neoplasms
• Interventions: Procedure: Selective hepatic vascular exclusion; Procedure: Infrahepatic inferior vena cava clamping; Procedure: Portal triad clamping

• Registration Number: NCT02405416
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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

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.

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted: 2015-03-07
• Study First Submitted QC: 2015-03-31
• Last Update Submitted: 2015-03-31
• Study First Posted: 2015-04-01
• Last Update Posted: 2015-04-01
• Primary Completion: 2017-03
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. either male or female, older than 18 (include 18).
2. tumors oppress or be in close proximity to one or more of major hepatic veins.
3. the maximum diameter of tumor ≥ 5cm, number of lesions ≤ 3 and should be in same liver lobe if multiple lesions exit.
4. preoperative liver function assessment: Child-Pugh classification is A or B.
5. preoperative laboratory test: blood platlet count > 100×10^9/l, prothrombin activity > 60%.
6. liver cirrhosis.

Exclusion Criteria

1. contraindication for surgery,e.g.severe disorders of circulation, respiratory or renal system.
2. extrahepatic metastasis in patients with malignancy or tumor invasion of portal vein, hepatic vein, bile duct or inferior vena cava.
3. hepatectomy accompanied with other organs resection(e.g. bile duct, intestine, pancreas or stomach)
4. regular hepatectomy.
5. tumors located in the left lateral lobe of liver.
6. previous hepatectomy.
7. pregnancy or lactation.
8. refusal to participate this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IIVCC group	Portal triad clamping	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.
SHVE group	Selective hepatic vascular exclusion	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.
SHVE group	Portal triad clamping	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.
IIVCC group	Infrahepatic inferior vena cava clamping	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.

Primary Outcome Measures

Name	Time	Method
Normalized transection-related blood loss	Intraoperative period	Intraoperative blood loss normalized by transection surface area
Intraoperative blood loss	Intraoperative period	blood loss from incision to closure

Secondary Outcome Measures

Name	Time	Method
Postrecovery of liver function	postoperative days 1, 3, 5, 7	Liver function evaluation is composite of liver enzyme ，total bilirubin, prothrombin activity, etc.
Postrecovery of renal function	postoperative days 1, 3, 5, 7	Renal function evaluation is composite of blood urea nitrogen, creatinine, etc.
Morbidity of postoperative complications	90 days after surgery
Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure	Intraoperative period
Postoperative mortality	90 days after surgery
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)
Time of infrahepatic inferior vena cava or selected hepatic vein dissection	Intraoperative period	Time cost of dissection

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China