Multiple Pulmonary Nodules Clinical Trial
Official title:
Combined Liver and Right Lung Resection for Colorectal Metastases by Means of J-shaped Thoracophrenolaparotomy
Verified date | March 2014 |
Source | University of Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Clinico Humanitas | Rozzano | Milan |
Lead Sponsor | Collaborator |
---|---|
University of Milan |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of metastases removed | 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) | Baseline: date of surgical operation | No |
Secondary | Number of patients that received interventional treatments after surgery | Participants will be followed from the baseline (date of surgery) to 90 days after the operation | Yes | |
Secondary | Number of re-operated patients | Participants will be followed from the baseline (date of surgery) to 90 days after the operation | Yes |
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