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Trial Title:
Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection
NCT ID:
NCT05728710
Condition:
Colorectal Neoplasms
Perforation of Rectum
Perforation Colon
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
endoscopic submucosal dissection
laterally spreading tumors
perforation
Study type:
Observational [Patient Registry]
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic submucosal dissection
Description:
standard ESD performed and complicated with a perprocedural or delayed perforation
Arm group label:
Perforation
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.
Criteria for eligibility:
Study pop:
all adults patients identified from the FECCO (NCT04592003) cohort experciencing
perprocedural or delayed perforation
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique CHC
Address:
City:
Liège
Country:
Belgium
Facility:
Name:
Clinique Anjou
Address:
City:
Angers
Country:
France
Facility:
Name:
CHU Bordeaux
Address:
City:
Bordeaux
Country:
France
Facility:
Name:
CHU Dijon
Address:
City:
Dijon
Country:
France
Facility:
Name:
CHU Dupuytren
Address:
City:
Limoges
Country:
France
Facility:
Name:
Hopital Edouard Herriot
Address:
City:
Lyon
Country:
France
Facility:
Name:
Hopital Privé Jean Mermoz
Address:
City:
Lyon
Country:
France
Facility:
Name:
Nancy Hospital Center
Address:
City:
Nancy
Zip:
54000
Country:
France
Facility:
Name:
Clinique Jules Verne
Address:
City:
Nantes
Country:
France
Facility:
Name:
Hopital Europeen Georges Pompidou
Address:
City:
Paris
Country:
France
Facility:
Name:
Hôpital Cochin
Address:
City:
Paris
Country:
France
Facility:
Name:
Hôpital Saint Joseph
Address:
City:
Paris
Country:
France
Facility:
Name:
CHU de Rennes
Address:
City:
Rennes
Country:
France
Start date:
September 1, 2019
Completion date:
April 1, 2023
Lead sponsor:
Agency:
Central Hospital, Nancy, France
Agency class:
Other
Source:
Central Hospital, Nancy, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05728710
