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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Expandable Stent | Experimental | Procedure/Surgery. Endeosocpically a self-expandable metal stent will be placed in the colon rectum. Chemotherapy will be added |
|
| Colorectal Resection | Active Comparator | Procedure/Surgery. A standard open or laparoscopic surgery will be performed to remove the colorectal cancer. Chemotherapy will be added |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT | Procedure | PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT |
|
| Measure | Description | Time Frame |
|---|---|---|
| MORTALITY | THE NUMBER OF POSTPROCEDURAL DEATHS | 60 DAYS |
| SURVIVAL | SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL | 5 YEARS |
| POSTOPERATIVE MORBIDITY | MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE | 60 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| QUALITY OF LIFE | QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL | 5 YEARS |
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Inclusion criteria
Exclusion criteria
-Patients considered at high risk for colorectal resection
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANTONIO STERPETTI, MD | Contact | 39-6-49972188 | antonio.sterpetti@uniroma1.it | |
| ENRICO FIORI, MD | Contact | 39-6-49972245 | enrico.fiori@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| antonietta lamazza, MD | University of Rome | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Pietro Valdoni | Recruiting | Rome | 00167 | Italy |
IPD data will be shared with publications and conferebnces
10.02.2018 for 3 months
contact by e-mail
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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RANDOMIZED CONTROLLED TRIAL
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|
| University of Rome Sapienza | Recruiting | Rome | 00167 | Italy |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |