NCT05728710

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
2 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

3.6 years

First QC Date

February 6, 2023

Last Update Submit

February 6, 2023

Conditions

Colorectal NeoplasmsPerforation of RectumPerforation Colon

Keywords

endoscopic submucosal dissectionlaterally spreading tumorsperforation

Outcome Measures

Primary Outcomes (1)

  • Surgery

    Rate of surgery following perforation after ESD

    30 days

Secondary Outcomes (6)

  • Hospital stay

    60 days

  • Hospital readmission

    30 days

  • Curative resection rate

    60 days

  • Endoscopically closed perforation rate

    30 days

  • Risk factors for endoscopic closure failure

    30 days

  • +1 more secondary outcomes

Study Arms (1)

Perforation

all patients with immediate or delayed perforation identified from the FECCO (NCT04592003)

Procedure: Endoscopic submucosal dissection

Interventions

Endoscopic submucosal dissectionPROCEDURE

standard ESD performed and complicated with a perprocedural or delayed perforation

Perforation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Clinique CHC

Liège, Belgium

Location

Clinique Anjou

Angers, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Dijon

Dijon, France

Location

CHU Dupuytren

Limoges, France

Location

Hopital Edouard Herriot

Lyon, France

Location

Hopital Privé Jean Mermoz

Lyon, France

Location

Nancy Hospital Center

Nancy, 54000, France

Location

Clinique Jules Verne

Nantes, France

Location

Hopital Europeen Georges Pompidou

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Saint Joseph

Paris, France

Location

CHU de Rennes

Rennes, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Marion Schaefer, MD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
48 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

September 1, 2019

Primary Completion

March 31, 2023

Study Completion

April 1, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)FR(12)