An interventional study of ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT in Colorectal Neoplasm, sponsored by University of Roma La Sapienza. Status unknown at 2 sites in Italy. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-03-06.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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
Exclusion criteria
-Patients considered at high risk for colorectal resection
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
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
PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT
Also known as: CHEMOTHERAPY
MORTALITY
THE NUMBER OF POSTPROCEDURAL DEATHS
Time frame: 60 DAYS
SURVIVAL
SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL
Time frame: 5 YEARS
POSTOPERATIVE MORBIDITY
MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE
Time frame: 60 DAYS
QUALITY OF LIFE
QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL
Time frame: 5 YEARS
Plan to share: Yes — IPD data will be shared with publications and conferebnces
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza