Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer

Colon Cancer Clinical Trial

— CROSCO-1  

Official title:

Colonic Resection, stOma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer. The CROSCO-1 Multicenter, Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05801211
• Other study ID #: Alessio Giordano
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2023
• Source: Azienda Sanitaria di Firenze
• Contact: Alessio Giordano
• Phone: +390557949173
• Email: alessio.giordano8[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

CROSCO-1 study is a national, multi-center, prospective observational study presenting patients to the emergency departments of the participating centers with obstructive left colon cancer (in the absence of metastases and peritoneal carcinomatosis) undergoing primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure") or staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS).

The main questions it aims to answer are:

• the Stoma rate at 1 year after tumor resection

• the 30-day and 90-day major morbidity and mortality

• 1-year quality of life (EQ-5D-5L test)

• Timing of chemotherapy initiation and type of chemotherapy regimen. Participants will have an obstructive left colon cancer localized (no peritoneal carcinosis or distant metastasis).

Researchers will compare: primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or an "Hartmann's procedure" with a staged resection after endoscopic stenting with SEMS.

Description:

Since surgical and oncological outcomes of the different treatment strategies for obstructing left colon cancers have not been studied on a large scale globally, we launched the CROSCO-1 study intending to compare the clinical results of all these therapeutic regimens in a cohort of patients treated for obstructive left-sided colorectal cancer (CRC).

The primary aim of the CROSCO-1 (Colonic Resection, stOma or self-expanding metal Stents for obstruCtive left cOlon cancer) study is to describe the outcomes of the management of emergency presentations of obstructive left CRC with colorectal resection with or without primary anastomosis versus the staged approach with SEMS insertion and subsequent colorectal resection. The primary aim of the CROSCO-1 study will be the 1-year stoma rate of patients undergoing primary emergency surgical resection (Hartmann procedure or primary resection and anastomosis) compared with patients undergoing staged resection (emergency endoscopic treatment with SEMS followed by elective resection). Other outcomes will be 30-day and 90-day major morbidity and mortality, 1-year quality of life, and the timing and type of chemotherapy initiation in the two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 434
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients of both sexes, = 18 years old.

2. Patients with abdominal CT scan diagnosis of colonic obstruction due to obstructive left colonic cancer (sigmoid or descending colon).

3. Absence of distant metastases on abdominal and chest CT scan.

4. Patients who may face a one-year follow-up.

5. Patients fit for surgery.

6. Patients with colonic adenocarcinoma on postoperative histological examination.

Exclusion Criteria:

1. Right-side or trasverse colon cancer.

2. Surgical or endoscopic palliation in patients with peritoneal carcinomatosis, locally advanced Colorectal cancer (CRC) (T4 sec. TNM), M1 disease.

3. Bowel obstruction determinated by other tumors or benign inflammatory stenosis.

4. Concomitant bowel abscess, perforation, or fistula.

5. Elective procedures.

6. Pregnancy or lactation.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• primary tumor resection
primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure")

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria di Firenze

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stoma rate at 1 year after tumor resection	the number of stomas after 1 year of primary surgery with tumor resection	1 year
Secondary	30-day and 90-day major morbidity	morbidity after 30 and 90-days	30-days; 90-days
Secondary	30-day and 90-day mortality	mortality (Overall survival) after 30 and 90-days	30-days; 90-days
Secondary	1-year quality of life (The 5-level EQ-5D version (EQ-5D-5L)test)	The EQ-5D-5L is an instrument to describe the quality of life with a state system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. In this first part, the patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions with graduate answers from 1 (no problem) to 5 (extreme limitations). The aggregation of the responses forms a five-digit number representing the patient's health status. in the second part, the patient is asked to indicate an assessment using a visual analog (VAS) graphically represented by a graduated scale ranging from 0 (the worst possible state of health) to 100 (the best possible state of health) on which the interviewee indicates his or her perceived level of health.	1-year
Secondary	Timing of chemotherapy initiation	data for chemotherapy initiation in both groups of study	2-years
Secondary	type of chemotherapy regimen	type of drugs regimen in both groups of study	2-years