Classical Procedure Versus Intrahepatic Glisson's Approach (LAHIGA)

January 29, 2016 updated by: Shuguo Zheng, MD

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital
        • Contact:
        • Principal Investigator:
          • shuguo Zheng, professer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intrahepatic Glisson's approach
Procedure: intrahepatic 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.
Other Names:
  • Laparoscopic with Intrahepatic Glssion's approach
ACTIVE_COMPARATOR: classical hepatectomy
Procedure: classical 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.
Other Names:
  • Laparoscopic anatomical hepatectomy with classical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with operation complication
Time Frame: 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.
Duration hospitalization(an expected average of 8 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with abnormal liver function or discomfort symptoms induced by the operation
Time Frame: 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.
up to 3 years postoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shuguo Zheng, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (ESTIMATE)

March 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWHZSG002
  • zhengshuguo (Registry Identifier: zhengshuguo)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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