Clinical trial NCT01283802: Intraoperative Cholangio-Ultrasound in Resective Liver Surgery
Official title: More Than 400 Hepatectomies Without Intraoperative Cholangiography: Prospective Validation of the Role of Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 448
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing resective liver surgery for hepatobiliary tumors

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.

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.

Primary outcomes:
measure: the technical feasibility
timeFrame: 90- days for postoperative morbidity and mortality
Secondary outcomes:
measure: Efficacy
timeFrame: 90-days for postoperative morbidity and mortality
Other outcomes:
Locations:
city: Rozzano - Milano
country: Italy
facility: Istituto Clinico Humanitas, Irccs
Study officials:
affiliation: University of Milan
name: GUIDO TORZILLI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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. doi: 10.1016/j.jamcollsurg.2005.04.026.
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.