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

Colorectal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03451643
• Other study ID #: 1010236
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2017
• Last updated: March 2, 2018
• Start date: February 2013
• Est. completion date: February 2020

Study information

• Verified date: March 2018
• Source: University of Roma La Sapienza
• Contact: ANTONIO STERPETTI, MD
• Phone: 39-6-49972188
• Email: antonio.sterpetti[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

Procedure:
• ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT
PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT

Locations

Country	Name	City	State
Italy	Istituto Pietro Valdoni	Rome
Italy	University of Rome Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MORTALITY	THE NUMBER OF POSTPROCEDURAL DEATHS	60 DAYS
Primary	SURVIVAL	SURVIVAL IN MONGTHS WILL BE DETERMINED FOR PATIENTS USING KAPLAN MEIER CURVES AND MEDIAN SURVIVAL	5 YEARS
Primary	POSTOPERATIVE MORBIDITY	MAJOR AND MINOR COMPLICATIONS AFTER THE PROCEDURE	60 DAYS
Secondary	QUALITY OF LIFE	QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL	5 YEARS