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UnknownNCT01567631

Classical Procedure Versus Intrahepatic Glisson's Approach

Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Shuguo Zheng, MD · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The purpose of this research is to compare the classical procedure with intrahepatic Glisson's approach for laparoscopic anatomical hepatectomy. The validity, feasibility and limitations were assessed objectively through our clinical prospective study. The investigators expect laparoscopic anatomical hepatectomy with intrahepatic Glisson's approach is safe, effective and feasible.

Detailed description

Background: China is the high incidence area of liver disease, some of which need to be treated by surgical liver resection. The development of minimal invasive techniques opened up a new situation for hepatectomy. Intrahepatic Glisson's approach and the classical procedure are the two major operation procedures used in laparoscopic hepatectomy. The intrahepatic Glisson's approach has the advantages of less intraoperative bleeding and shorter operation time in our experience and as previous studies. The investigators expect further comparison of the safety and efficacy through this prospective controlled study by using two kinds of operation procedures. Intervention: Classical procedure versus intrahepatic Glisson's approach: a prospective randomized study. Eighty patients with liver disease need undergo hepatectomy were selected and divided into intrahepatic Glisson's group and classical procedure group randomly, each group contains 40 cases. Total laparoscopic hepatectomy were performed, with the intrahepatic Glisson's approach or classical procedure respectively. Results: 1. Clinical data include: operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function,long-term curative effect were collected and analysed. 2. Statistical method: groups t-test univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis were used.

Conditions

Interventions

TypeNameDescription
PROCEDUREintrahepatic Glisson's approachForty patients with liver disease were selected and divided into intrahepatic Glission's group as described in the detailed description.Total laparoscopic hepatectomy with intrahepatic Glisson's approach were performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle (containing arterial, portal, and bile duct branches ). A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler. The specimen was extracted through suprapubic incision.
PROCEDUREclassical hepatectomyForty patients with liver disease were selected and divided into classical laparoscopic hepatectomy group as described in the detailed description.Total laparoscopic anatomical hepatectomy with classical procedure were performed.The initial step is to dissect hepatic portal and expose the liver artery, portal Vein branch and the bile duct. Then endoscopic stapler devices were used to cut the canal mentioned above. Final step is to divide the liver parenchyma along the following ischemic delineation.

Timeline

Start date
2012-01-01
Primary completion
2017-12-01
Completion
2017-12-01
First posted
2012-03-30
Last updated
2016-02-01

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01567631. Inclusion in this directory is not an endorsement.