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NCT05728710 Clinical Trial

Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection

Colorectal Neoplasms Clinical Trial

Official title:
Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05728710
Other study ID # 2022PI178
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date April 1, 2023

Study information
Verified date February 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 350
Est. completion date April 1, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic submucosal dissection
standard ESD performed and complicated with a perprocedural or delayed perforation

Locations
Country Name City State
Belgium Clinique CHC Liège
France Clinique Anjou Angers
France CHU Bordeaux Bordeaux
France CHU Dijon Dijon
France CHU Dupuytren Limoges
France Hopital Edouard Herriot Lyon
France Hopital Privé Jean Mermoz Lyon
France Nancy Hospital Center Nancy
France Clinique Jules Verne Nantes
France Hôpital Cochin Paris
France Hopital Europeen Georges Pompidou Paris
France Hôpital Saint Joseph Paris
France CHU de Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Countries where clinical trial is conducted

Belgium,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgery Rate of surgery following perforation after ESD 30 days
Secondary Hospital stay length of hospital stay (days) 60 days
Secondary Hospital readmission 30 days
Secondary Curative resection rate 60 days
Secondary Endoscopically closed perforation rate 30 days
Secondary Risk factors for endoscopic closure failure 30 days
Secondary 30-days mortality rate 30 days
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