Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial.
Journal
Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351
Informations de publication
Date de publication:
12 Dec 2023
12 Dec 2023
Historique:
medline:
11
12
2023
pubmed:
11
12
2023
entrez:
11
12
2023
Statut:
aheadofprint
Résumé
Endoscopic resection of adenomas prevents colorectal cancer, but the optimal technique for larger lesions is controversial. Piecemeal endoscopic mucosal resection (EMR) has a low adverse event (AE) rate but a variable recurrence rate necessitating early follow-up. Endoscopic submucosal dissection (ESD) can reduce recurrence but may increase AEs. To compare ESD and EMR for large colonic adenomas. Participant-masked, parallel-group, superiority, randomized controlled trial. (ClinicalTrials.gov: NCT03962868). Multicenter study involving 6 French referral centers from November 2019 to February 2021. Patients with large (≥25 mm) benign colonic lesions referred for resection. The patients were randomly assigned by computer 1:1 (stratification by lesion location and center) to ESD or EMR. The primary end point was 6-month local recurrence (neoplastic tissue on endoscopic assessment and scar biopsy). The secondary end points were technical failure, en bloc R0 resection, and cumulative AEs. In total, 360 patients were randomly assigned to ESD ( Procedures were performed under general anesthesia during hospitalization in accordance with the French health system. Compared with EMR, ESD reduces the 6-month recurrence rate, obviating the need for systematic early follow-up colonoscopy at the cost of more AEs. French Ministry of Health.
Sections du résumé
BACKGROUND
UNASSIGNED
Endoscopic resection of adenomas prevents colorectal cancer, but the optimal technique for larger lesions is controversial. Piecemeal endoscopic mucosal resection (EMR) has a low adverse event (AE) rate but a variable recurrence rate necessitating early follow-up. Endoscopic submucosal dissection (ESD) can reduce recurrence but may increase AEs.
OBJECTIVE
UNASSIGNED
To compare ESD and EMR for large colonic adenomas.
DESIGN
UNASSIGNED
Participant-masked, parallel-group, superiority, randomized controlled trial. (ClinicalTrials.gov: NCT03962868).
SETTING
UNASSIGNED
Multicenter study involving 6 French referral centers from November 2019 to February 2021.
PARTICIPANTS
UNASSIGNED
Patients with large (≥25 mm) benign colonic lesions referred for resection.
INTERVENTION
UNASSIGNED
The patients were randomly assigned by computer 1:1 (stratification by lesion location and center) to ESD or EMR.
MEASUREMENTS
UNASSIGNED
The primary end point was 6-month local recurrence (neoplastic tissue on endoscopic assessment and scar biopsy). The secondary end points were technical failure, en bloc R0 resection, and cumulative AEs.
RESULTS
UNASSIGNED
In total, 360 patients were randomly assigned to ESD (
LIMITATION
UNASSIGNED
Procedures were performed under general anesthesia during hospitalization in accordance with the French health system.
CONCLUSION
UNASSIGNED
Compared with EMR, ESD reduces the 6-month recurrence rate, obviating the need for systematic early follow-up colonoscopy at the cost of more AEs.
PRIMARY FUNDING SOURCE
UNASSIGNED
French Ministry of Health.
Banques de données
ClinicalTrials.gov
['NCT03962868']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM