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

Not Applicable

• Conditions: Colorectal Neoplasm
• Interventions: Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT

• Registration Number: NCT03451643
• Lead Sponsor: University of Roma La Sapienza

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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2018-02-23
• Status Verified: 2018-03
• Study First Posted: 2018-03-02
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-06
• Primary Completion: 2018-12
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Expandable Stent	ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT	Procedure/Surgery. Endeosocpically a self-expandable metal stent will be placed in the colon rectum. Chemotherapy will be added
Colorectal Resection	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

Primary Outcome Measures

Name	Time	Method
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
MORTALITY	60 DAYS	THE NUMBER OF POSTPROCEDURAL DEATHS

Secondary Outcome Measures

Name	Time	Method
QUALITY OF LIFE	5 YEARS	QUALITY OF LIFE WILL BE ASSESSED USING A STANDARDIZED PROTOCOL

Trial Locations

Locations (2)

Istituto Pietro Valdoni; 🇮🇹 Rome, Italy

University of Rome Sapienza; 🇮🇹 Rome, Italy