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Trial record 79 of 489 for:    colon cancer AND resection

Combined Liver and Right Lung Resection for Colorectal Metastases by Means of J-shaped Thoracophrenolaparotomy

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.
 
ClinicalTrials.gov Identifier: NCT02090816
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan

Brief Summary:
The purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is effective in the surgical treatment of simultaneous liver and right lung metastases from colorectal cancer

Condition or disease Intervention/treatment
Colon Cancer Liver Metastasis Multiple Pulmonary Nodules Procedure: Surgery of liver and lung

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Combined Liver and Right Lung Resection for Colorectal Metastases by Means of J-shaped Thoracophrenolaparotomy
Study Start Date : September 2004
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment
Surgery of liver and lung
Patients carriers of both liver and right lung metastases in the same time
Procedure: Surgery of liver and lung
Simultaneous resection of liver and right lung metastases in a single surgical session through a new approach




Primary Outcome Measures :
  1. Number of metastases removed [ Time Frame: Baseline: date of surgical operation ]
    Evaluation of the resectability of whole metastases in liver and right lung in the same operation by means of the same surgical incision (J-shaped thoracophrenolaparotomy)


Secondary Outcome Measures :
  1. Number of patients that received interventional treatments after surgery [ Time Frame: Participants will be followed from the baseline (date of surgery) to 90 days after the operation ]
  2. Number of re-operated patients [ Time Frame: Participants will be followed from the baseline (date of surgery) to 90 days after the operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tertiary care clinic
Criteria

Inclusion Criteria:

  • Controlled primary disease;
  • No extrahepatic lesion other than resectable pulmonary metastases at preoperative investigation;
  • No lymph-node metastases except for those eventually present at the hepatic hilum;
  • Disregarding number and distribution of liver metastases, technical resectability leaving at least a remnant liver volume of at least 40% of the total liver volume (calculated excluding the tumoral volume) featured by preserved inflow, outflow and biliary drainage. Zero mm free margin was considered acceptable in case of contact or close adjacency (< 5 mm) with 1st or 2nd order portal pedicles and/or major hepatic veins at their caval confluence;
  • Disregarding number and distribution of lung metastases, all of the detected nodules could be completely removed preserving enough functioning remnant lung based on the results of the preoperative cardio-pulmonary functional tests;
  • Patients eligible for a J-shaped thoracophrenolaparotomy because carrier of liver metastases located at the caval confluence, or in the paracaval portion of segment 1 or in the upper right segments (4 superior, 7 and 8), or presenting strong-adhesion or infiltration of the diaphragm.

Exclusion Criteria:

  • Patients not suitable for surgery

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): NCT02090816


Locations
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Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20084
Sponsors and Collaborators
University of Milan
Investigators
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Principal Investigator: Guido Torzilli, MD PhD FACS University of Milan

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Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan
ClinicalTrials.gov Identifier: NCT02090816    
Other Study ID Numbers: Liver-lung-001
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplasms by Site
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Multiple Pulmonary Nodules
Neoplastic Processes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Liver Extracts
Hematinics