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Alternative to Two-Stage Hepatectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00587756
First Posted: January 7, 2008
Last Update Posted: January 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fondazione Humanitas per la Ricerca
Information provided by:
University of Milan
  Purpose
Two-stage hepatectomy with or without portal vein embolization allows to treat multiple bilobar metastases expanding surgical indications for these patients. However, it has some related drawbacks: two operations are needed, and some patients do not complete the treatment strategy for disease progression. Using experience gained from our ultrasound guided resection policy we explored the safety and effectiveness of one-stage surgical procedures in patients otherwise recommended for the two-stage approach.

Condition Intervention
Colorectal Cancer Liver Metastases Procedure: One-stage ultrasound guided hepatectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: One-Stage Ultrasound-Guided Hepatectomy for Multiple Bilobar Colorectal Metastases: a Feasible and Effective Alternative to Two-Stage Hepatectomy

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • The primary outcome was the safety of the procedure. To this purpose we studied morbidity, mortality, amount of blood loss, rate of blood transfusions, and postoperative trend of liver function tests. [ Time Frame: 30-day and 90-day postoperatively ]

Secondary Outcome Measures:
  • The secondary outcome measure was the reliability of the procedure from an oncological standpoint. For this purpose we studied the rate of true local recurrence (cut-edge) after a minimum follow-up of 6 months. [ Time Frame: Minimum Follow-up of 6 months ]

Enrollment: 19
Study Start Date: September 2001
Study Completion Date: December 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Prospective cohort of consecutive patients who undergo surgery for colorectal cancer liver metastases
Procedure: One-stage ultrasound guided hepatectomy
Surgical strategy was based on tumor-vessel relationship at intraoperative ultrasonography (IOUS)and on findings at color-Doppler IOUS.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients carriers of colorectal cancer liver metastases
Criteria

Inclusion Criteria:

  1. Patients presenting with resectable colorectal cancer liver metastases (CLM)
  2. 4 or more lesions
  3. Bilobar involvement of the liver
  4. Contact or close adjacency (less than 0.5 cm) of at least one CLM with major intrahepatic vascular structures (1st or 2nd order portal branches and/or hepatic vein at caval confluence).

Exclusion Criteria:

  1. Patients with 3 or less resectable CLM
  2. Patients with 4 or more resectable CLM but nor bilobar
  3. Patients with 4 or more bilobar resectable CLM without any lesion presenting condition of point 4 of the inclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587756


Locations
Italy
Istituto Clinico Humanitas - Irccs
Rozzano - Milano, Italy, 20089
Sponsors and Collaborators
University of Milan
Fondazione Humanitas per la Ricerca
Investigators
Principal Investigator: Guido Torzilli, MD, PhD University of Milan, Istituto Clinico Humanitas - IRCCS
  More Information

Publications:
Responsible Party: Prof. Guido Torzilli, University of Milan, Istituto Clinico Humanitas - IRCCS
ClinicalTrials.gov Identifier: NCT00587756     History of Changes
Other Study ID Numbers: MTX-1STAGE
MTX-CRC-1STAGE
First Submitted: January 3, 2008
First Posted: January 7, 2008
Last Update Posted: January 8, 2008
Last Verified: December 2007

Keywords provided by University of Milan:
intraoperative ultrasonography
colorectal liver metastases
hepatectomy
portal vein embolization
Liver

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes