A Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy

Sponsor
Southwest Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT04422249
Collaborator
(none)
95
1
2
36
2.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Two different treatments are conducted on the participant base on the randomized choices
Primary Purpose:
Treatment
Official Title:
A RCT Study of Laparoscopic Middle Hepatic Vein Guidance and Traditional Anatomic Hemihepatectomy
Actual Study Start Date :
Dec 23, 2019
Anticipated Primary Completion Date :
Dec 23, 2022
Anticipated Study Completion Date :
Dec 23, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: laparoscopic middle hepatic vein guidance hemihepatectomy

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.

Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy
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
Other Names:
  • laparoscopic traditional anatomic hemihepatectomy
  • Active Comparator: laparoscopic traditional anatomic hemihepatectomy

    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.

    Procedure: laparoscopic middle hepatic vein guidance anatomic hemihepatectomy
    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
    Other Names:
  • laparoscopic traditional anatomic hemihepatectomy
  • Outcome Measures

    Primary Outcome Measures

    1. Survival rate [3 years]

      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

    1. Perioperative results [Duration perioperation(an expected average of 3 days)]

      the angle of hepatic vein between segment Ⅳ b and Ⅴ, angle between MHV and IVC

    2. intraoperative parameters [during the operation]

      blood loss per unit area will be combined to report intraoperative parameters in milliliter/square centimetre(ml/c㎡)

    Other Outcome Measures

    1. Incidence of postoperative complications [Duration hospitalization(an expected average of 7 days)]

      hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiopulmonary insufficiency,liver function failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. the site was limited to the patients who were suitable for dissecting hemihepatectomy;

    2. the type of disease was limited to hepatocellular carcinoma;

    3. the patients were generally able to tolerate anesthesia, the liver reserve function was good, and the patients were suitable for laparoscopic surgery;

    4. child-pugh grade A, no severe liver cirrhosis, portal hypertension, no extrahepatic and extrahepatic metastasis and main vascular invasion;

    5. 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;

    6. 18 ≤ age ≤ 70, male or female.

    Exclusion Criteria:
    1. preoperative liver function Child-pugh grade B or C;

    2. patients with poor general condition and could not tolerate pneumoperitoneum or anesthesia;

    3. patients with severe liver cirrhosis, portal hypertension and lesions invading liver porta;

    4. patients with other treatment methods such as radio frequency ablation in addition to dissecting hepatectomy;

    5. repeated abdominal operations resulting in severe abdominal adhesion, unable to perform laparoscopic hepatectomy; male and female are not limited

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southwest Hospital Chongqing Chongqing China 400038

    Sponsors and Collaborators

    • Southwest Hospital, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shuguo Zheng, MD, Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department, Southwest Hospital, China
    ClinicalTrials.gov Identifier:
    NCT04422249
    Other Study ID Numbers:
    • SWHZSG009
    First Posted:
    Jun 9, 2020
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shuguo Zheng, MD, Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department, Southwest Hospital, China
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 14, 2022