Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection

February 6, 2023 updated by: Marion SCHAEFER, Central Hospital, Nancy, France
Endoscopic resection of superficial colorectal neoplasms decrease risk of colorectal cancer. En bloc resection is necessary for large superficial lesions with risk of superficial submucosal cancer and is advised if feasible for all lesions. Endoscopic submucosal dissection (ESD) allows en bloc resection of large superficial colorectal neoplasms, increasing curative resection rate and decreasing local recurrence risk. However, the risk of perprocedural or delayed perforation is higher compared to wild field piece meal endoscopic mucosal resection. Endoscoping clipping and closing methods mostly allow conservative treatment, but some case still necessitate surgery. The aim of our study is to describe and ananalyse outcomes after perprocedural or delayed perforation in all patients undergoing ESD and analyse the need for surgical intervention.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

350

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

  • Belgium
      • Liège, Belgium
        • Clinique CHC
  • France
      • Angers, France
        • Clinique Anjou
      • Bordeaux, France
        • CHU Bordeaux
      • Dijon, France
        • CHU Dijon
      • Limoges, France
        • CHU Dupuytren
      • Lyon, France
        • Hôpital Edouard Herriot
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Nancy, France, 54000
        • Nancy Hospital Center
      • Nantes, France
        • Clinique Jules Verne
      • Paris, France
        • Hôpital Cochin
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Hôpital Saint Joseph
      • Rennes, France
        • CHU de Rennes

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

all adults patients identified from the FECCO (NCT04592003) cohort experciencing perprocedural or delayed perforation

Description

Inclusion Criteria:

  • patients from the FECCO (NCT04592003) cohort experiencing perprocedural or delayed perforation
  • age over 18 years old

Exclusion Criteria:

  • patients refusing exploitations of health datas
  • patient treated with endoscopic mucosal resection

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
Perforation
all patients with immediate or delayed perforation identified from the FECCO (NCT04592003)
Procedure: Endoscopic submucosal dissection
standard ESD performed and complicated with a perprocedural or delayed perforation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery
Time Frame: 30 days
Rate of surgery following perforation after ESD
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: 60 days
length of hospital stay (days)
60 days
Hospital readmission
Time Frame: 30 days
30 days
Curative resection rate
Time Frame: 60 days
60 days
Endoscopically closed perforation rate
Time Frame: 30 days
30 days
Risk factors for endoscopic closure failure
Time Frame: 30 days
30 days
30-days mortality rate
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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 (Anticipated)

March 31, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI178

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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