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Alternative to Two-Stage Hepatectomy

This study has been completed.
Sponsor:
Collaborator:
Fondazione Humanitas per la Ricerca
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00587756
First received: January 3, 2008
Last updated: January 7, 2008
Last verified: December 2007
  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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 3, 2008
Last Updated: January 7, 2008
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 27, 2014