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

Primary Purpose

Biliary Stones

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Laparoscopic operation

Open operation

About this trial

This is an interventional treatment trial for Biliary Stones focused on measuring Hepatolithiasis, Minimal invasive surgery, Laparoscopic hepatectomy, Choledochoscope

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic operation

Open operation

Arm 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.

The traditional open regular hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.

Outcomes

Primary Outcome Measures

Number of participants with residual stones or cholangitis symptoms

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

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.

Full Information

NCT ID

NCT01563510

First Posted

March 21, 2012

Last Updated

October 8, 2012

Sponsor

Shuguo Zheng, MD

1. Study Identification

Unique Protocol Identification Number

NCT01563510

Brief Title

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

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shuguo Zheng, MD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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. Statistical method: univariate/multivariate analysis, logistic regression analysis, mixed linear regression, Cox survival analysis were used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Stones

Keywords

Hepatolithiasis, Minimal invasive surgery, Laparoscopic hepatectomy, Choledochoscope

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic operation

Arm Type

Experimental

Arm Description

Arm Title

Open operation

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic operation

Other Intervention Name(s)

Laparoscopic hepatectomy for early regional hepatolithiasis

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Open operation

Other Intervention Name(s)

Open operation for regional hepatolithiasis

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants with residual stones or cholangitis symptoms

Description

Time Frame

up to 5 years postoperation

Secondary Outcome Measure Information:

Title

Number of participants with operation complication

Description

Time Frame

Duration hospitalization(an expected average of 2 weeks) to 2 months postoperation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40% Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved Other organ lesions and previous biliary tract operation is not the absolute exclusion criteria Written informed consent Exclusion Criteria: Age: older than 70 years old, younger than 18 years old Patients with bad general condition or important organ lesions, liver resection could not be tolerated Complicated case needed to get emergency operation Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis Combined with severe biliary cirrhosis and portal hypertension, severe varicose of hepatic portal vein , hepatic insufficiency Diagnosed with cholangiocellular carcinoma intraoperatively or by postoperative pathology 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shuguo Zheng, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400038

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

17468921

Citation

Uchiyama K, Kawai M, Ueno M, Ozawa S, Tani M, Yamaue H. Reducing residual and recurrent stones by hepatectomy for hepatolithiasis. J Gastrointest Surg. 2007 May;11(5):626-30. doi: 10.1007/s11605-006-0024-8.

Results Reference

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PubMed Identifier

11231390

Citation

Lee SK, Seo DW, Myung SJ, Park ET, Lim BC, Kim HJ, Yoo KS, Park HJ, Joo YH, Kim MH, Min YI. Percutaneous transhepatic cholangioscopic treatment for hepatolithiasis: an evaluation of long-term results and risk factors for recurrence. Gastrointest Endosc. 2001 Mar;53(3):318-23. doi: 10.1016/s0016-5107(01)70405-1.

Results Reference

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PubMed Identifier

19249730

Citation

Uenishi T, Hamba H, Takemura S, Oba K, Ogawa M, Yamamoto T, Tanaka S, Kubo S. Outcomes of hepatic resection for hepatolithiasis. Am J Surg. 2009 Aug;198(2):199-202. doi: 10.1016/j.amjsurg.2008.08.020. Epub 2009 Feb 27.

Results Reference

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PubMed Identifier

10437840

Citation

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Results Reference

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PubMed Identifier

19916210

Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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

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