Hepatic Haemangioma, Liver Diseases, Liver Neoplasms
Conditions
Keywords
Classical Procedure, Intrahepatic Glisson's Approach, laparoscopic hepatectomy, Minimal invasive surgery, Endoscopic stapling devices
Brief 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.
Interventions
PROCEDUREintrahepatic Glisson's approach
Forty 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 hepatectomy
Forty 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.
Sponsors
Shuguo Zheng, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with liver malignant or benign disease distributed in a segment, lobe or half liver, malignant tumor ≤5 cm, without rupture, bleeding, and liver metastases, benign tumor ≤15cm. 2. Liver function \> Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open hepatectomy were achieved 3. Age: Between 18 to 70 years 4. Patients with regional stones distributed in a segment, lobe or half liver, combined or not combined with extrahepatic biliary calculi, hepatic parenchymal atrophy or fibrosis in the lesion region 5. Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved 6. Other organ lesions and previous biliary tract operation is not the absolute
Exclusion criteria
7. Written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with operation complication | Duration hospitalization(an expected average of 8 days) | Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function were collected and analysed to evaluate the safety of the operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal liver function or discomfort symptoms induced by the operation | up to 3 years postoperation | Liver function, quality of life and survival time were collected and analysed to evaluate the postoperative curative effect. The examination of ultrasound , CT and/or MR were perfomed in outpatient if necessary. The follow up interval time: every six months. |
Countries
China
Contacts
Primary ContactShuguo Zheng
Outcome results
None listed