Clinical trial NCT05728710: Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection
Official title: Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Perforation of Rectum
Perforation Colon
Keywords: endoscopic submucosal dissection
laterally spreading tumors
perforation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adults patients identified from the FECCO (NCT04592003) cohort experciencing perprocedural or delayed perforation

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.


Eligibility 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

Primary outcomes:
measure: Surgery
timeFrame: 30 days
Secondary outcomes:
measure: Hospital stay
timeFrame: 60 days
measure: Hospital readmission
timeFrame: 30 days
measure: Curative resection rate
timeFrame: 60 days
measure: Endoscopically closed perforation rate
timeFrame: 30 days
measure: Risk factors for endoscopic closure failure
timeFrame: 30 days
measure: 30-days mortality rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Clinique CHC
city: Angers
country: France
facility: Clinique Anjou
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Dijon
country: France
facility: CHU Dijon
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Lyon
country: France
facility: Hopital Privé Jean Mermoz
city: Nancy
country: France
facility: Nancy Hospital Center
city: Nantes
country: France
facility: Clinique Jules Verne
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Central Hospital, Nancy, France
name: Marion Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References: