Intraoperative Cholangio-Ultrasound in Resective Liver Surgery

Completed

• Conditions: Liver Cancer
• Interventions: Procedure: INTRAOPERATIVE CHOLANGIO-ULTRASOUND

• Registration Number: NCT01283802
• Lead Sponsor: University of Milan

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.

Study Timeline

• Study Start: 2004-06
• Status Verified: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-25
• Last Update Submitted: 2011-01-25
• Study First Posted: 2011-01-26
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IOCUS	INTRAOPERATIVE CHOLANGIO-ULTRASOUND	-

Primary Outcome Measures

Name	Time	Method
the technical feasibility	90- days for postoperative morbidity and mortality

Secondary Outcome Measures

Name	Time	Method
Efficacy	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

Trial Locations

Locations (1)

Istituto Clinico Humanitas, Irccs; 🇮🇹 Rozzano - Milano, Italy