Stenting and Resection for Stage IV Colorectal Cancer Endoscopic Stenting and Colorectal Resection in Stage IV

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Comparison Between Endoscopic Stenting and Colorectal Resection in Patients With Stage IV Colorectal Cancer

Conditions
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Colorectal Neoplasm

Intervention / Treatment
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* Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RANDOMIZED CONTROLLED TRIAL
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Expandable Stent<br>Procedure/Surgery. Endeosocpically a self-expandable metal stent will be placed in the colon rectum. Chemotherapy will be added | Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT<br>* PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT<br>* Other names: CHEMOTHERAPY;|
| Active Comparator: Colorectal Resection<br>Procedure/Surgery. A standard open or laparoscopic surgery will be performed to remove the colorectal cancer. Chemotherapy will be added | Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT<br>* PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT<br>* Other names: CHEMOTHERAPY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QUALITY OF LIFE | QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL | 5 YEARS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, liver metastases, stage IV