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

University of Roma La Sapienza

Status: Unknown

Conditions: Colorectal Neoplasm

Treatments: Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT

Study type: Interventional

Funder types: Other

Identifiers

NCT03451643

1010236

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Endoscopic Expandable Stent

Experimental group

Description:

Procedure/Surgery. Endeosocpically a self-expandable metal stent will be placed in the colon rectum. Chemotherapy will be added

Treatment:

Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT

Colorectal Resection

Active Comparator group

Description:

Procedure/Surgery. A standard open or laparoscopic surgery will be performed to remove the colorectal cancer. Chemotherapy will be added

Treatment:

Procedure: ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT