NCT01283802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
Last Updated

January 26, 2011

Status Verified

June 1, 2010

First QC Date

January 24, 2011

Last Update Submit

January 25, 2011

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • the technical feasibility

    90- days for postoperative morbidity and mortality

Secondary Outcomes (1)

  • Efficacy

    90-days for postoperative morbidity and mortality

Study Arms (1)

IOCUS

Procedure: INTRAOPERATIVE CHOLANGIO-ULTRASOUND

Interventions

INTRAOPERATIVE CHOLANGIO-ULTRASOUNDPROCEDURE

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.

IOCUS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing resective liver surgery for hepatobiliary tumors

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas, Irccs

Rozzano - Milano, 20086, Italy

Location

Related Publications (5)

  • 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.

    PMID: 19015467BACKGROUND

  • 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.

    PMID: 19541011BACKGROUND

  • 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.

    PMID: 18362622BACKGROUND

  • 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.

    PMID: 16183489BACKGROUND

  • 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.

    PMID: 10370628BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • GUIDO TORZILLI, MD, PhD

    University of Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 26, 2011

Study Start

June 1, 2004

Study Completion

June 1, 2010

Last Updated

January 26, 2011

Record last verified: 2010-06

Locations

IT(1)