Intraoperative Cholangio-Ultrasound in Resective Liver Surgery (IOCUS)

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT01283802
First received: January 24, 2011
Last updated: January 25, 2011
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • the technical feasibility [ Time Frame: 90- days for postoperative morbidity and mortality ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:

  1. Direct ultrasound exploration without any contrast agents.
  2. IOCUS injection into the bile duct of a mixture of air and saline (2 parts water and 1 part air);
  3. IOCUS injection of an air bolus into the bile duct.

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.

  1. Machi J, Oishi AJ, Furumoto NL, Oishi RH (2004). Intraoperative ultrasound. Surg Clin North Am, 84(4): 1085-111
  2. 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
  3. 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
  4. Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma (2004). Surg Endosc, 18(1):136-9
  5. 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
  6. 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
  7. 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
Study Population

Patients undergoing resective liver surgery for hepatobiliary tumors

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01283802

Locations
Italy
Istituto Clinico Humanitas, Irccs
Rozzano - Milano, Italy, 20086
Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: GUIDO TORZILLI, MD, PhD University of Milan
  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 August 28, 2014