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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shuguo Zheng, MD, Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01563510
First received: March 21, 2012
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Biliary Stones
Procedure: Laparoscopic operation
Procedure: Open operation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Laparoscopic Versus Open Operation for Hepatolithiasis

Resource links provided by NLM:


Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • Number of participants with residual stones or cholangitis symptoms [ Time Frame: up to 5 years postoperation ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of participants with operation complication [ Time Frame: Duration hospitalization(an expected average of 2 weeks) to 2 months postoperation ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Open operation for regional hepatolithiasis

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01563510

Locations
China, Chongqing
Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Shuguo Zheng, MD
Investigators
Study Director: Shuguo Zheng, MD Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
  More Information

Publications:

Responsible Party: Shuguo Zheng, MD, Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department;, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01563510     History of Changes
Other Study ID Numbers: SWHZSG001, zhengshuguo
Study First Received: March 21, 2012
Last Updated: October 8, 2012
Health Authority: China: Ministry of Health

Keywords provided by Southwest Hospital, China:
Hepatolithiasis
Minimal invasive surgery
Laparoscopic hepatectomy
Choledochoscope

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 29, 2014