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

Biliary Stones Clinical Trial

Official title:

Comparison of Laparoscopic Versus Open Operation for Hepatolithiasis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01563510
• Other study ID #: SWHZSG001
• Secondary ID: zhengshuguo
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 21, 2012
• Last updated: October 8, 2012
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: October 2012
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Stones

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Shuguo Zheng, MD

Country where clinical trial is conducted

China, 

References & Publications (9)

Buell JF, Cherqui D, Geller DA, O'Rourke N, Iannitti D, Dagher I, Koffron AJ, Thomas M, Gayet B, Han HS, Wakabayashi G, Belli G, Kaneko H, Ker CG, Scatton O, Laurent A, Abdalla EK, Chaudhury P, Dutson E, Gamblin C, D'Angelica M, Nagorney D, Testa G, Labow D, Manas D, Poon RT, Nelson H, Martin R, Clary B, Pinson WC, Martinie J, Vauthey JN, Goldstein R, Roayaie S, Barlet D, Espat J, Abecassis M, Rees M, Fong Y, McMasters KM, Broelsch C, Busuttil R, Belghiti J, Strasberg S, Chari RS; World Consensus Conference on Laparoscopic Surgery. The international position on laparoscopic liver surgery: The Louisville Statement, 2008. Ann Surg. 2009 Nov;250(5):825-30. — View Citation

Cho JY, Han HS, Yoon YS, Shin SH. Experiences of laparoscopic liver resection including lesions in the posterosuperior segments of the liver. Surg Endosc. 2008 Nov;22(11):2344-9. doi: 10.1007/s00464-008-9966-0. Epub 2008 Jun 5. — View Citation

Lai EC, Ngai TC, Yang GP, Li MK. Laparoscopic approach of surgical treatment for primary hepatolithiasis: a cohort study. Am J Surg. 2010 May;199(5):716-21. doi: 10.1016/j.amjsurg.2009.02.007. Epub 2009 Dec 3. — View 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. — View Citation

Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection-2,804 patients. Ann Surg. 2009 Nov;250(5):831-41. doi: 10.1097/SLA.0b013e3181b0c4df. Review. — View Citation

Otani K, Shimizu S, Chijiiwa K, Ogawa T, Morisaki T, Sugitani A, Yamaguchi K, Tanaka M. Comparison of treatments for hepatolithiasis: hepatic resection versus cholangioscopic lithotomy. J Am Coll Surg. 1999 Aug;189(2):177-82. — View 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. — View 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. — View Citation

Zhang L, Chen YJ, Shang CZ, Zhang HW, Huang ZJ. Total laparoscopic liver resection in 78 patients. World J Gastroenterol. 2009 Dec 7;15(45):5727-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 5 years postoperation	Yes
Secondary	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.	Duration hospitalization(an expected average of 2 weeks) to 2 months postoperation	Yes