Back to resultsA Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic middle hepatic vein guidance anatomic hemihepatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Laparoscopic Middle hepatic vein Hepatocellular carcinoma
Eligibility Criteria
Inclusion Criteria:
- the site was limited to the patients who were suitable for dissecting hemihepatectomy；
- the type of disease was limited to hepatocellular carcinoma；
- the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery；
- child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion；
- the subjects who participated in this study indicated that they were willing to accept the two surgical methods and agreed to be randomly divided into groups during the operation；
- 18 ≤ age ≤ 70, male or female.
Exclusion Criteria:
- preoperative liver function Child-pugh grade B or C;
- patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia;
- patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta;
- patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy;
- repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited
Sites / Locations
- Southwest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
laparoscopic middle hepatic vein guidance hemihepatectomy
laparoscopic traditional anatomic hemihepatectomy
Arm Description
In theory, the advantages of anatomical hemihepatectomy guided by middle hepatic vein are as follows: 1) correctly guiding the transecting plane of the liver parenchyma can reduce the cross-sectional area of the liver and avoid damaging the vascular ducts of the pre-cut liver. so as to reduce the residue of necrotic tissue without blood supply and reduce the occurrence of postoperative complications. 2) active anatomy and exposure of hepatic vein can avoid uncontrollable bleeding after passive injury of hepatic vein, and laparoscopic anatomy has obvious advantage in exposing hepatic vein. 3) it may reduce the early recurrence rate of hepatocellular carcinoma after operation.
According to textbooks and the views of some scholars at present, traditional anatomical hepatectomy (non-hepatic vein-guided anatomical hepatectomy) has the following advantages: 1) avoiding exposure of hepatic vein can reduce the probability of injury to the trunk of hepatic vein, thus reduce the risk of massive bleeding during operation; 2) the difficulty of operation is relatively low, and a better short-term and long-term effect can be obtained.
Outcomes
Primary Outcome Measures
Survival rate
follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival
Secondary Outcome Measures
Perioperative results
the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC
intraoperative parameters
blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡）
Full Information
NCT ID
NCT04422249
First Posted
May 20, 2020
Last Updated
January 13, 2022
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04422249
Brief Title
A Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
Official Title
A RCT Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
December 23, 2022 (Anticipated)
Study Completion Date
December 23, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study, entitled "RCT study of laparoscopic middle hepatic venous guidance versus conventional ananatomical hemihepatectomy", was designed to compare the efficacy of two different ananatomical hemihepatectomy procedures under laparoscopy.
Detailed Description
Backgroud & Aim:Hepatectomy is the main way to treat all kinds of liver surgical diseases, which can be divided into anatomic hepatectomy and non-anatomic hepatectomy.Among them, anatomic hepatectomy is suitable for primary liver cancer, hepatolithiasis and other benign and malignant diseases;It can be divided into hepatic venous guidance and non-hepatic venous guidance hepatectomy (traditional ananatomical hepatectomy).The aim of this study was to observe and compare the perioperative period and follow-up results of the two different laparoscopic surgical resection methods, and to provide high-level evidence-based medicine evidence for the selection of surgical methods for laparoscopic anatomical hemihepatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Laparoscopic Middle hepatic vein Hepatocellular carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Two different treatments are conducted on the participant base on the randomized choices
Allocation
Randomized
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic middle hepatic vein guidance hemihepatectomy
Arm Type
Experimental
Arm Description
In theory, the advantages of anatomical hemihepatectomy guided by middle hepatic vein are as follows: 1) correctly guiding the transecting plane of the liver parenchyma can reduce the cross-sectional area of the liver and avoid damaging the vascular ducts of the pre-cut liver. so as to reduce the residue of necrotic tissue without blood supply and reduce the occurrence of postoperative complications. 2) active anatomy and exposure of hepatic vein can avoid uncontrollable bleeding after passive injury of hepatic vein, and laparoscopic anatomy has obvious advantage in exposing hepatic vein. 3) it may reduce the early recurrence rate of hepatocellular carcinoma after operation.
Arm Title
laparoscopic traditional anatomic hemihepatectomy
Arm Type
Active Comparator
Arm Description
According to textbooks and the views of some scholars at present, traditional anatomical hepatectomy (non-hepatic vein-guided anatomical hepatectomy) has the following advantages: 1) avoiding exposure of hepatic vein can reduce the probability of injury to the trunk of hepatic vein, thus reduce the risk of massive bleeding during operation; 2) the difficulty of operation is relatively low, and a better short-term and long-term effect can be obtained.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic middle hepatic vein guidance anatomic hemihepatectomy
Other Intervention Name(s)
laparoscopic traditional anatomic hemihepatectomy
Intervention Description
95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period
Primary Outcome Measure Information:
Title
Survival rate
Description
follow-up after the surgery every 3 months, to understand statistics 1-year overall survival、3-year overall survival、1-year disease-free survival、3-year disease-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Perioperative results
Description
the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC
Time Frame
Duration perioperation(an expected average of 3 days)
Title
intraoperative parameters
Description
blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡）
Time Frame
during the operation
Other Pre-specified Outcome Measures:
Title
Incidence of postoperative complications
Description
hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiopulmonary insufficiency，liver function failure
Time Frame
Duration hospitalization(an expected average of 7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the site was limited to the patients who were suitable for dissecting hemihepatectomy；
the type of disease was limited to hepatocellular carcinoma；
the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery；
child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion；
the subjects who participated in this study indicated that they were willing to accept the two surgical methods and agreed to be randomly divided into groups during the operation；
18 ≤ age ≤ 70, male or female.
Exclusion Criteria:
preoperative liver function Child-pugh grade B or C;
patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia;
patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta;
patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy;
repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuguo Zheng, M.D.
Phone
0086-13508308676
Email
shuguozh@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shuguo Zheng, Zheng
Phone
0086-13508308676
Email
shuguozh@yahoo.com.cn
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuguo Zheng, MD
Phone
0086-13508308676
Email
shuguozh@yahoo.com.cn
12. IPD Sharing Statement
Learn more about this trial
A Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
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