Classical Procedure Versus Intrahepatic Glisson's Approach

Not Applicable

• Conditions: Liver Neoplasms; Hepatic Haemangioma; Liver Diseases
• Interventions: Procedure: intrahepatic Glisson's approach; Procedure: classical hepatectomy

• Registration Number: NCT01567631
• Lead Sponsor: Shuguo Zheng, MD

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-03-30
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

1. Patients with bad general condition or important organ lesions, liver resection could not be tolerated
2. Age:Younger than 18 or more than 70 years old
3. Malignant tumor recurrence within one month postoperation
4. Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
5. Complicated case need to get emergency operation
6. Contraindication of laparoscopy: Combined with complicated acute cholangitis, repeated biliary tract operation, heavy intra-abdominal adhesion, Trocar can not be placed in. Artificial pneumoperitoneum could not be tolerated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrahepatic Glisson's approach	intrahepatic Glisson's approach	-
classical hepatectomy	classical hepatectomy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China