Intraoperative Cholangio-Ultrasound in Resective Liver Surgery (IOCUS)
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|ClinicalTrials.gov Identifier: NCT01283802|
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : January 26, 2011
|Condition or disease||Intervention/treatment|
|Liver Cancer||Procedure: INTRAOPERATIVE CHOLANGIO-ULTRASOUND|
Intraoperative ultrasonography (IOUS) in liver surgery is widely accepted as a fundamental tool for radical and safe hepatectomy . New technical improvements of IOUS have been reported in recent years both for tumor characterization and staging  and for resection guidance [3-5]. However, intraoperative cholangiography (IOC) still represents the gold standard for studying the biliary tract anatomy as well as for guiding reconstruction in case of bile duct resection and, moreover, with the advent of living donation it is the standard reference for validating preoperative imaging . Conversely, it could be affirmed that IOUS in this sense has no role, if not for guiding intraoperative dilated bile duct drainage . Nevertheless, IOC has not negligible costs, it implies the use of x-ray, iodated contrast agents and is time consuming.
Herein is proposed a technique for bile duct exploration by means of intraoperative cholangio-ultrasound (IOCUS) validated on a consecutive series of patients undergoing liver resection.
- Machi J, Oishi AJ, Furumoto NL, Oishi RH (2004). Intraoperative ultrasound. Surg Clin North Am, 84(4): 1085-111
- Minagawa M, Makuuchi M, Takayama T, Ohtomo K (2001). Selection criteria for hepatectomy in patients with hepatocellular carcinoma and portal vein tumor thrombus. Ann Surg, 233(3): 379-84
- Torzilli G, Del Fabbro D, Olivari N, Calliada F, Montorsi M, Makuuchi M (2004). Contrast-enhanced intraoperative ultrasonography during liver surgery. Br J Surg, 91(9): 1165-7
- Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma (2004). Surg Endosc, 18(1):136-9
- Torzilli G, Takayama T, Hui AM, Kubota K, Harihara Y, Makuuchi M (1999). A new technical aspect of ultrasound-guided liver surgery. Am J Surg, 178(4): 341-3
- Lee VS, Krinsky GA, Nazzaro CA, Chang JS, Babb JS, Lin JC, Morgan GR, Teperman LW. Defining intrahepatic biliary anatomy in living liver transplant donor candidates at mangafodipir trisodium-enhanced MR cholangiography versus conventional T2-weighted MR cholangiography. Radiology, 2004; 233(3): 659-66
- Torzilli G, Makuuchi M, Komatsu Y, Noie T, Abe H, Kobayashi T, Kubota K, Takayama T. US guided biliary drainage during hepatopancreatico-jejunostomy for diffuse bile duct carcinoma. Hepatogastroenterology. 1999; 46(26): 863-6.
|Study Type :||Observational|
|Actual Enrollment :||448 participants|
|Official Title:||More Than 400 Hepatectomies Without Intraoperative Cholangiography: Prospective Validation of the Role of Ultrasound|
|Study Start Date :||June 2004|
|Study Completion Date :||June 2010|
Procedure: INTRAOPERATIVE CHOLANGIO-ULTRASOUND
Techniques are as follows:
- the technical feasibility [ Time Frame: 90- days for postoperative morbidity and mortality ]
- Efficacy [ Time Frame: 90-days for postoperative morbidity and mortality ]Efficacy in providing the proper information validated by postoperative outcome and in particular by the absence of an undrained portion of the liver after resection, biliary reconstruction or bilio-enteric anastomoses, and the absence of consistent bile leaks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283802
|Istituto Clinico Humanitas, Irccs|
|Rozzano - Milano, Italy, 20086|
|Principal Investigator:||GUIDO TORZILLI, MD, PhD||University of Milan|