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

NCT ID: NCT02405416

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-06-30

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.

Conditions

Liver Neoplasms; Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IIVCC group

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.

Group Type: EXPERIMENTAL

Infrahepatic inferior vena cava clamping

Intervention Type: PROCEDURE

Infrahepatic inferior vena cava is clamped in hepatectomy.

Portal triad clamping

Intervention Type: PROCEDURE

Portal triad are clamped in hepatectomy.

SHVE group

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.

Group Type: ACTIVE_COMPARATOR

Selective hepatic vascular exclusion

Intervention Type: PROCEDURE

Selected major hepatic vein is clamped in hepatectomy.

Portal triad clamping

Intervention Type: PROCEDURE

Portal triad are clamped in hepatectomy.

Interventions

Infrahepatic inferior vena cava clamping

Infrahepatic inferior vena cava is clamped in hepatectomy.

Intervention Type: PROCEDURE

Selective hepatic vascular exclusion

Selected major hepatic vein is clamped in hepatectomy.

Intervention Type: PROCEDURE

Portal triad clamping

Portal triad are clamped in hepatectomy.

Intervention Type: PROCEDURE

Other Intervention Names

IIVCC; SHVE; PTC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xiaoping Chen

Chairman and Professor of Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoping Chen, M.D.

Role: STUDY_CHAIR

Tongji Hospital

Locations

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoping Chen, M.D.

Role: CONTACT

chenxp@medmail.com.cn

+86 27 83662851

Chao Wu, M.M.

Role: CONTACT

dr_wuchao@hust.edu.cn

+8618986136006

Facility Contacts

Xiaoping Chen, M.D.

Role: primary

chenxp@medmail.com.cn

+86 27 83662851

Chao Wu, M.M.

Role: backup

dr_wuchao@hust.edu.cn

+86 18986136006

Other Identifiers

2012ZX10002016-004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

chenxp006

Identifier Type: -

Identifier Source: org_study_id