Clinical trial NCT01563510: Research of the Key Technology and Standardization of Minimal Invasive Treatment for Hepatolithiasis
Official title: Comparison of Laparoscopic Versus Open Operation for Hepatolithiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Stones
Keywords: Hepatolithiasis
Minimal invasive surgery
Laparoscopic hepatectomy
Choledochoscope
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with residual stones or cholangitis symptoms
timeFrame: up to 5 years postoperation
Secondary outcomes:
measure: Number of participants with operation complication
timeFrame: Duration hospitalization(an expected average of 2 weeks) to 2 months postoperation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
state: Chongqing
Study officials:
affiliation: Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
name: Shuguo Zheng, MD
role: STUDY_DIRECTOR
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