Noncurative Endoscopic Resection of Colorectal Adenocarcinoma (NoncurativeESD)

March 17, 2021 updated by: Istituto Clinico Humanitas

Long-term Outcomes After Noncurative Endoscopic Resection of Colorectal Adenocarcinoma

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Endoscopy Unit, Humanitas Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent a non-curative colorectal endoscopic submucosal dissection (ESD). Curative resection was defined as follows: en bloc resection (tumor removal in one piece without fragmentation) and R0 resection (negative horizontal and vertical resected margins) of a neoplastic (adenocarcinoma) lesion with no lymphovascular infiltration (LVI), no budding, no undifferentiated tumor (G3), no deep invasion (T1 sm3 or deeper).

Patients are required to meet none of the exclusion criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 6 Months
Overall survival cancer-specific survival and disease-free survival rate after noncurative ESD.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Non_curativeESD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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