Colorectal Neoplasm
Conditions
Keywords
colorectal cancer, liver metastases, stage IV
Brief summary
Patients with Stage IV obstructing colorectal cancer and unresectable liver metastses, with general and local conditions not a risk for coliorectal resection, will be randomized to have either endoscopic stenting or colorectal resection
Detailed description
Patients with obstructing colorectal cancer, Stage IV with not resectable metastases will be considered . Patients with acceptable general and local conditions, to allow a safe surgical resection will be considered. Patients will be randomized to have endoscopic stenting or colorectal resection. All patients will receive postoperative chemio therapy
Interventions
PROCEDUREENDOSCOPIC PLACEMENT OF EXPANDABLE STENT
PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
RANDOMIZED CONTROLLED TRIAL
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Stage IV obstructing colorectal cancer and liver metastases * Liver metastases not resectable
Exclusion criteria
-Patients considered at high risk for colorectal resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MORTALITY | 60 DAYS | THE NUMBER OF POSTPROCEDURAL DEATHS |
| SURVIVAL | 5 YEARS | SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL |
| POSTOPERATIVE MORBIDITY | 60 DAYS | MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QUALITY OF LIFE | 5 YEARS | QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL |
Countries
Italy
Contacts
Primary ContactANTONIO STERPETTI, MD
Backup ContactENRICO FIORI, MD
Outcome results
None listed