Intraoperative Cholangio-Ultrasound in Resective Liver Surgery

NCT ID: NCT01283802

Last Updated: 2011-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 448 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2010-06-30

Brief 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.

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.

Conditions

Liver Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IOCUS

INTRAOPERATIVE CHOLANGIO-ULTRASOUND

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

UNIVERSITY OF MILAN

Principal Investigators

GUIDO TORZILLI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

Istituto Clinico Humanitas, Irccs

Rozzano - Milano, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 19015467 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19541011 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18362622 (View on PubMed)

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. doi: 10.1016/j.jamcollsurg.2005.04.026.

Reference Type: BACKGROUND

PMID: 16183489 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10370628 (View on PubMed)

Other Identifiers

IOCUS

Identifier Type: -

Identifier Source: org_study_id