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

Primary Purpose

Liver Neoplasms, Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Infrahepatic inferior vena cava clamping
Selective hepatic vascular exclusion
Portal triad clamping
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring Hepatocellular Carcinoma, Blood Loss, Haemorrhage, Vascular Control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IIVCC group

SHVE group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intraoperative blood loss
blood loss from incision to closure
Normalized transection-related blood loss
Intraoperative blood loss normalized by transection surface area

Secondary Outcome Measures

Time of infrahepatic inferior vena cava or selected hepatic vein dissection
Time cost of dissection
Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure
Drop of hemoglobin level
Postrecovery of liver function
Liver function evaluation is composite of liver enzyme ，total bilirubin, prothrombin activity, etc.
Postrecovery of renal function
Renal function evaluation is composite of blood urea nitrogen, creatinine, etc.
Morbidity of postoperative complications
Postoperative mortality

Full Information

First Posted
March 7, 2015
Last Updated
March 31, 2015
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02405416
Brief Title
Infrahepatic Inferior Vena Cava Clamping Versus Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping
Official Title
A Prospective Randomized Controlled Trial to Compare Infrahepatic Inferior Vena Cava Clamping With Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping in Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms, Liver Cirrhosis
Keywords
Hepatocellular Carcinoma, Blood Loss, Haemorrhage, Vascular Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IIVCC group
Arm Type
Experimental
Arm Description
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.
Arm Title
SHVE group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Infrahepatic inferior vena cava clamping
Other Intervention Name(s)
IIVCC
Intervention Description
Infrahepatic inferior vena cava is clamped in hepatectomy.
Intervention Type
Procedure
Intervention Name(s)
Selective hepatic vascular exclusion
Other Intervention Name(s)
SHVE
Intervention Description
Selected major hepatic vein is clamped in hepatectomy.
Intervention Type
Procedure
Intervention Name(s)
Portal triad clamping
Other Intervention Name(s)
PTC
Intervention Description
Portal triad are clamped in hepatectomy.
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
blood loss from incision to closure
Time Frame
Intraoperative period
Title
Normalized transection-related blood loss
Description
Intraoperative blood loss normalized by transection surface area
Time Frame
Intraoperative period
Secondary Outcome Measure Information:
Title
Time of infrahepatic inferior vena cava or selected hepatic vein dissection
Description
Time cost of dissection
Time Frame
Intraoperative period
Title
Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure
Time Frame
Intraoperative period
Title
Drop of hemoglobin level
Time Frame
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)
Title
Postrecovery of liver function
Description
Liver function evaluation is composite of liver enzyme ，total bilirubin, prothrombin activity, etc.
Time Frame
postoperative days 1, 3, 5, 7
Title
Postrecovery of renal function
Description
Renal function evaluation is composite of blood urea nitrogen, creatinine, etc.
Time Frame
postoperative days 1, 3, 5, 7
Title
Morbidity of postoperative complications
Time Frame
90 days after surgery
Title
Postoperative mortality
Time Frame
90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoping Chen, M.D.
Phone
+86 27 83662851
Email
chenxp@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chao Wu, M.M.
Phone
+8618986136006
Email
dr_wuchao@hust.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen, M.D.
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen, M.D.
Phone
+86 27 83662851
Email
chenxp@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Chao Wu, M.M.
Phone
+86 18986136006
Email
dr_wuchao@hust.edu.cn

12. IPD Sharing Statement

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

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