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

Not Applicable

• Conditions: Biliary Stones
• Interventions: Procedure: Laparoscopic operation; Procedure: Open operation

• Registration Number: NCT01563510
• Lead Sponsor: Shuguo Zheng, MD

Brief Summary

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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-27
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-08
• Last Update Posted: 2012-10-10
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic operation	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.
Open operation	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with residual stones or cholangitis symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with operation complication	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.

Trial Locations

Locations (1)

Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China