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

NCT01563510 | Unknown DMC

• 2 other identifiers: SWHZSG001zhengshuguo
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Stones

Keywords

Hepatolithiasis; Minimal invasive surgery; Laparoscopic hepatectomy; Choledochoscope

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of participants with operation complication

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

Study Arms (2)

Laparoscopic operation

EXPERIMENTAL

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

Open operation

ACTIVE COMPARATOR

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

Interventions

Laparoscopic operation PROCEDURE

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.

Also known as: Laparoscopic hepatectomy for early regional hepatolithiasis

Laparoscopic operation

Open operation PROCEDURE

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.

Also known as: Open operation for regional hepatolithiasis

Open operation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Written informed consent
• 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

Sponsors & Collaborators

• Shuguo Zheng, MD: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400038, China

Location

Related Publications (9)

• 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.

  PMID: 17468921 BACKGROUND

• 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.

  PMID: 11231390 BACKGROUND

• 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.

  PMID: 19249730 BACKGROUND

• 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. doi: 10.1016/s1072-7515(99)00109-x.

  PMID: 10437840 BACKGROUND

• 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. doi: 10.1097/sla.0b013e3181b3b2d8.

  PMID: 19916210 BACKGROUND

• 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.

  PMID: 19959158 BACKGROUND

• 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.

  PMID: 18528623 BACKGROUND

• 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. doi: 10.3748/wjg.15.5727.

  PMID: 19960572 BACKGROUND

• 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.

  PMID: 19801936 BACKGROUND

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

Heller Myotomy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Officials

• Shuguo Zheng, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department;

Study Record Dates

• First Submitted: March 21, 2012
• First Posted: March 27, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

CN (1)