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

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Liver Neoplasms
• Intervention / Treatment: Procedure: Infrahepatic inferior vena cava clamping; Procedure: Portal triad clamping; Procedure: Selective hepatic vascular exclusion

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Xiaoping Chen, M.D.; Phone Number: +86 27 83662851; Email: chenxp@medmail.com.cn
      • Contact: Chao Wu, M.M.; Phone Number: +86 18986136006; Email: dr_wuchao@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Infrahepatic inferior vena cava clamping; Infrahepatic inferior vena cava is clamped in hepatectomy.; Other Names: IIVCC; Procedure: Portal triad clamping; Portal triad are clamped in hepatectomy.; Other Names: PTC
Active Comparator: 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.	Procedure: Portal triad clamping; Portal triad are clamped in hepatectomy.; Other Names: PTC; Procedure: Selective hepatic vascular exclusion; Selected major hepatic vein is clamped in hepatectomy.; Other Names: SHVE

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Chair: Xiaoping Chen, M.D., Tongji Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: March 7, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Haemorrhage; Blood Loss; Vascular Control
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Fibrosis; Liver Cirrhosis; Liver Neoplasms
• Other Study ID Numbers: chenxp006; 2012ZX10002016-004 (Other Grant/Funding Number: The State Key Project on Inflection Disease of China)