Intraoperative Cholangio-Ultrasound in Resective Liver Surgery

Liver Cancer Clinical Trial

— IOCUS  

Official title:

More Than 400 Hepatectomies Without Intraoperative Cholangiography: Prospective Validation of the Role of Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283802
• Other study ID #: IOCUS
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: January 25, 2011
• Start date: June 2004
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Cancer

Intervention

Procedure:
• INTRAOPERATIVE CHOLANGIO-ULTRASOUND
Techniques are as follows: Direct ultrasound exploration without any contrast agents. IOCUS injection into the bile duct of a mixture of air and saline (2 parts water and 1 part air); IOCUS injection of an air bolus into the bile duct.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas, Irccs	Rozzano - Milano

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7. — View Citation

Torzilli G, Donadon M, Marconi M, Palmisano A, Del Fabbro D, Spinelli A, Botea F, Montorsi M. Hepatectomy for stage B and stage C hepatocellular carcinoma in the Barcelona Clinic Liver Cancer classification: results of a prospective analysis. Arch Surg. 2008 Nov;143(11):1082-90. doi: 10.1001/archsurg.143.11.1082. — View Citation

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 Mar-Apr;46(26):863-6. — View Citation

Torzilli G, Montorsi M, Donadon M, Palmisano A, Del Fabbro D, Gambetti A, Olivari N, Makuuchi M. "Radical but conservative" is the main goal for ultrasonography-guided liver resection: prospective validation of this approach. J Am Coll Surg. 2005 Oct;201(4):517-28. — View Citation

Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71. doi: 10.1016/j.surg.2009.02.017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the technical feasibility		90- days for postoperative morbidity and mortality	Yes
Secondary	Efficacy	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	90-days for postoperative morbidity and mortality	Yes