Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors (REC)

May 23, 2018 updated by: Institut Paoli-Calmettes
To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intra-mucous colorectal neoplasia lesions (or even with minimal mucosal infiltration), formerly treated surgically, are increasingly treated endoscopically.

The IPC as a center for interventional endoscopy has been taking care of these lesions for several years.

Resection techniques have diversified since the 2000s (polypectomy, monobloc or piecemeal mucosectomy, submucosal dissection ... etc) and the endoscopy team has developed its various techniques within the institute ; Practice has evolved and has not been studied or evaluated in recent years. The purpose of this study is to evaluate practices and to compare results with the literature, and to identify predictive factors for the failure or success of endoscopic treatment of these early neoplastic lesions.

Study Type

Observational

Enrollment (Actual)

100

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

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Institut Paoli Calmettes

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

Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification

Description

Inclusion Criteria:

  • Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.

Exclusion Criteria:

  • Adenomas with low grade dysplasia
  • Endoscopic control not available

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
endoscopic resection of a colorectal lesion
Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.
Other: Evaluation of the long-term complete remission rate (> 12 months)
Evaluation of the long-term complete remission rate (> 12 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete long-term remission (> 12 months)
Time Frame: 13 months
Evaluation of the long-term complete remission rate (> 12 months)
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of residual lesion on early control (3 to 6 months)
Time Frame: 3 to 6 months
Medium-term response rate (3 to 6 months)
3 to 6 months
Rates of medium and long-term recurrence
Time Frame: 13 months
Recurrence rate in the medium and long term
13 months
Management of medium and long-term recurrence
Time Frame: 13 months
Management of recurrence (endoscopic revision or surgery)
13 months
Morbidity and mortality rates
Time Frame: 13 months
Morbidity and mortality rate of endoscopic resection
13 months
Lymph node or visceral metastatic evolution rate
Time Frame: 13 months
Rate of pejorative lymph node or metastatic evolution (especially for lesions with microinfiltration of the submucosa)
13 months
Endoscopic description and anatomopathological results
Time Frame: 1 day
Endoscopic and / or anatomopathological predictive factors of success (complete long-term remission)
1 day

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Jean-Philippe RATONE, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2012

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

November 2, 2017

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-IPC 2017-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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