Research of the Key Technology and Standardization of Minimal Invasive Treatment for Hepatolithiasis

October 8, 2012 updated by: Shuguo Zheng, MD

Comparison of Laparoscopic Versus Open Operation for Hepatolithiasis

The purpose of this research is to investigate the key technology and the related issues of minimal invasive treatment for hepatolithiasis and to build new methods of minimal invasive operation for hepatolithiasis. The validity, feasibility and limitations of the laparoscopic operation were assessed objectively through our clinical prospective study. The technique points, indications and contraindications were summarized to evaluate the status and role of minimal invasive laparoscopic operation in the treatment of hepatolithiasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: China is the high incidence area of hepatolithiasis. The development of minimal invasive techniques opened up a new situation for the treatment of hepatolithiasis, but it has not been widely applied.

Intervention: Comparison of minimal invasive versus open operation for hepatolithiasis: a prospective randomized study. One hundred patients with early regional hepatolithiasis were selected and divided into laparoscopic operation group and open operation group randomly, each group contains 50 cases. Laparoscopic anatomical hepatectomy or open regular hepatectomy were performed respectively, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.

Results:

  1. Clinical data: previous operation history, operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, residual stones, recurrence rate, long-term curative effect and survival time were collected and analysed.
  2. Statistical method: univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis were used.

Study Type

Interventional

Enrollment (Anticipated)

100

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
        • Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

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 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
  2. Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%
  3. Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved
  4. Other organ lesions and previous biliary tract operation is not the absolute exclusion criteria
  5. Written informed consent

Exclusion Criteria:

  1. Age: older than 70 years old, younger than 18 years old
  2. Patients with bad general condition or important organ lesions, liver resection could not be tolerated
  3. Complicated case needed to get emergency operation
  4. Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
  5. Combined with severe biliary cirrhosis and portal hypertension, severe varicose of hepatic portal vein , hepatic insufficiency
  6. Diagnosed with cholangiocellular carcinoma intraoperatively or by postoperative pathology
  7. 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic operation
Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound, choledochoscope and hepatic segmental staining were used selectively.
Procedure: Laparoscopic operation
Fifty patients with early regional hepatolithiasis were selected and divided into laparoscopic hepatectomy group as described in the detailed description. Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound, choledochoscope and hepatic segmental staining were used selectively.
Other Names:
  • Laparoscopic hepatectomy for early regional hepatolithiasis
Active Comparator: Open operation
The traditional open regular hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.
Procedure: Open operation
Fifty patients with early regional hepatolithiasis were selected and divided into open group as described in the detailed description. The traditional open regular hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.
Other Names:
  • Open operation for regional hepatolithiasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with residual stones or cholangitis symptoms
Time Frame: up to 5 years postoperation
Liver function, recurrence rate, cholangitis symptoms, quality of life and survival time were collected and analysed to evaluate the postoperative curative effect. The follow up interval time: every six months.
up to 5 years postoperation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with operation complication
Time Frame: Duration hospitalization(an expected average of 2 weeks) to 2 months postoperation
Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function, residual stones were collected and analysed to evaluate the safety and effectiveness of the operation.
Duration hospitalization(an expected average of 2 weeks) to 2 months postoperation

Collaborators and Investigators

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

Sponsor

Shuguo Zheng, MD

Investigators

  • Study Director: Shuguo Zheng, MD, Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

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 21, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

October 10, 2012

Last Update Submitted That Met QC Criteria

October 8, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWHZSG001
  • 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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