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Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

Primary Purpose

Cancer Progression

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hepatectomy (conventional method)
hepatectomy (rapid ligating)
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 Cancer Progression focused on measuring hepatocellular carcinoma, prognosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HCC patients who will perform left- or right- hemihepatectomy.

Exclusion Criteria:

  1. contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)>30%,serum hepatitis B virus (HBV)-DNA>106 copies/ml and serum alanine aminotransferase (ALT)>2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause;
  2. pregnancy;
  3. age of<18y or>65y

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional resection

new method

Arm Description

Perform hepatectomy with conventional method for HCC patients.

The new technique of rapid ligating the corresponding inflow and outflow vessels without hills dissection before parenchyma transection during hepatectomy.

Outcomes

Primary Outcome Measures

recurrence
to examine if there is intrahepatic recurrence
metastasis
to examine if there is intrahepatic metastasis and metastasis in distant organs
mortality
intraoperative death， and death in one month after surgery

Secondary Outcome Measures

Prognosis
to check the 5 years overall survival (OS) and disease free survival (DFS)

Full Information

First Posted
December 11, 2014
Last Updated
December 15, 2014
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02319863
Brief Title
Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
Official Title
A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 1994 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (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 study examines the role of this simple technique on postoperative metastasis and long term survival.
Detailed Description
The only hope of long-term survival for patients with primary hepatocellular carcinoma (HCC) is surgical resection or liver transplantation, the former of which is more feasible at present. However, postoperative recurrence or metastasis is an ominous feature for this disease. Innovation of the surgical procedure for improving prognosis is under emergency request. This study examines the role of this simple technique on postoperative metastasis and long term survival. During the past 20 years, more 600 patients with primary HCC were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (RCT) was applied. We further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Progression
Keywords
hepatocellular carcinoma, prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional resection
Arm Type
Active Comparator
Arm Description
Perform hepatectomy with conventional method for HCC patients.
Arm Title
new method
Arm Type
Experimental
Arm Description
The new technique of rapid ligating the corresponding inflow and outflow vessels without hills dissection before parenchyma transection during hepatectomy.
Intervention Type
Procedure
Intervention Name(s)
hepatectomy (conventional method)
Other Intervention Name(s)
liver resection
Intervention Description
A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
Intervention Type
Procedure
Intervention Name(s)
hepatectomy (rapid ligating)
Primary Outcome Measure Information:
Title
recurrence
Description
to examine if there is intrahepatic recurrence
Time Frame
12 months
Title
metastasis
Description
to examine if there is intrahepatic metastasis and metastasis in distant organs
Time Frame
12 months
Title
mortality
Description
intraoperative death， and death in one month after surgery
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Prognosis
Description
to check the 5 years overall survival (OS) and disease free survival (DFS)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HCC patients who will perform left- or right- hemihepatectomy. Exclusion Criteria: contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C,indocyanine green retention rate at 15min (ICGR15)>30%,serum hepatitis B virus (HBV)-DNA>106 copies/ml and serum alanine aminotransferase (ALT)>2×ULN, serum triglycerides>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause; pregnancy; age of<18y or>65y
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
Binhao Zhang, M.D.
Phone
+86 15802726021
Email
bhzhang8@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen, M.D.
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
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
Binhao Zhang, M.D.
Phone
+86 15802726021
Email
bhzhang8@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
17978838
Citation
Chen XP, Qiu FZ. A simple technique ligating the corresponding inflow and outflow vessels during anatomical left hepatectomy. Langenbecks Arch Surg. 2008 Mar;393(2):227-30; discussion 231-4. doi: 10.1007/s00423-007-0224-z. Epub 2007 Nov 3.
Results Reference
background

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Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy

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