Noncurative Endoscopic Resection of Colorectal Adenocarcinoma

Noncurative Resection Clinical Trial

— NoncurativeESD  

Official title:

Long-term Outcomes After Noncurative Endoscopic Resection of Colorectal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987828
• Other study ID #: Non_curativeESD
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication. We performed a retrospective revision of outcome data by clinical report review or phone calls.

Description:

Patients with noncurative resection after ESD for CRC were considered for additional surgical treatment. Then, they either underwent surgery with curative intent or did not, according to patients choice and surgeons indication / contraindication. We performed a retrospective revision of outcome data by clinical report review or phone calls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• undergoing non-curative colorectal endoscopic submucosal dissection (ESD).

Exclusion Criteria:

• Histology other than cancer (adenocarcinoma).
• History of inflammatory bowel disease (IBD).
• Genetic conditions predisposing to CR.
• Lost to follow up or less than 6 months of follow up.

Related Conditions & MeSH terms

• Adenocarcinoma
• Noncurative Resection

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.	6 Months