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

NCT02090816 | Completed

• 1 other identifier: Liver-lung-001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Colon Cancer Liver Metastasis; Multiple Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• Number of re-operated patients

  Participants will be followed from the baseline (date of surgery) to 90 days after the operation

Study Arms (1)

Surgery of liver and lung

Patients carriers of both liver and right lung metastases in the same time

Procedure: Surgery of liver and lung

Interventions

Surgery of liver and lung PROCEDURE

Simultaneous resection of liver and right lung metastases in a single surgical session through a new approach

Surgery of liver and lung

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tertiary care clinic

You may qualify if:

• 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.

You may not qualify if:

• Patients not suitable for surgery

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20084, Italy

Location

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guido Torzilli, MD PhD FACS

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: March 18, 2014
• Study Start: September 1, 2004
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

IT (1)