Intraoperative Cholangio-Ultrasound in Resective Liver Surgery (IOCUS)
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Purpose
Liver surgery should be considered an echo-guided procedure to guarantee conservative but radical resections. The investigators describe a further application of intraoperative ultrasonography (IOUS) for studying the biliary tree during liver surgery with no need for formal cholangiography.
| Condition | Intervention |
|---|---|
|
Liver Cancer |
Procedure: INTRAOPERATIVE CHOLANGIO-ULTRASOUND |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | More Than 400 Hepatectomies Without Intraoperative Cholangiography: Prospective Validation of the Role of Ultrasound |
- the technical feasibility [ Time Frame: 90- days for postoperative morbidity and mortality ] [ Designated as safety issue: Yes ]
- Efficacy [ Time Frame: 90-days for postoperative morbidity and mortality ] [ Designated as safety issue: Yes ]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
| Enrollment: | 448 |
| Study Start Date: | June 2004 |
| Study Completion Date: | June 2010 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| IOCUS |
Procedure: INTRAOPERATIVE CHOLANGIO-ULTRASOUND
Techniques are as follows:
|
Detailed Description:
Intraoperative ultrasonography (IOUS) in liver surgery is widely accepted as a fundamental tool for radical and safe hepatectomy [1]. New technical improvements of IOUS have been reported in recent years both for tumor characterization and staging [2] 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 [6]. Conversely, it could be affirmed that IOUS in this sense has no role, if not for guiding intraoperative dilated bile duct drainage [7]. 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients undergoing resective liver surgery for hepatobiliary tumors
Inclusion Criteria:
Patients who need:
- clarification of the bile duct anatomy;
- disclosure of eventual intrahepatic bile duct dilation;
- verification of the patency of a sutured bile duct after tumor detachment from a glissonian sheath;
- check of the drainage of a bile duct stump on the liver cut surface prior to bilio-enteric anastomoses.
Contacts and Locations
More Information
Publications:
| Responsible Party: | GUIDO TORZILLI MD, PHD, UNIVERSITY OF MILAN |
| ClinicalTrials.gov Identifier: | NCT01283802 History of Changes |
| Other Study ID Numbers: | IOCUS |
| Study First Received: | January 24, 2011 |
| Last Updated: | January 25, 2011 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 23, 2013