TOPLINE:
For large colonic adenomas, endoscopic submucosal dissection (ESD) reduces the local recurrence rate compared with endoscopic mucosal resection (EMR), but the adverse event rate is higher.
METHODOLOGY:
- In RESECT-COLON, a parallel-group superiority trial conducted at six French centers, 360 patients (median age, about 70 years) with large (≥ 25 mm) benign colonic lesions were randomly assigned to ESD or EMR. After exclusions, 318 patients were included in the primary protocol analysis.
- In the EMR group, thermal margin ablation was performed in almost all (98.9%) of the patients. In the ESD group, double-clip traction with a rubber band was used in 94.3% of patients.
- The primary endpoint was 6-month local recurrence (neoplastic tissue on endoscopic assessment and scar biopsy).
- Secondary endpoints were technical failure, en bloc R0 resection, and cumulative adverse events.
TAKEAWAY:
- Recurrence occurred after 1 of 161 ESDs (0.6%) and 8 of 157 EMRs (5.1%) — a significant difference. No recurrence occurred after R0 resection with ESD, obviating the need for early follow-up colonoscopy.
- En bloc resection rates were higher in the ESD group (96.6%) than in the EMR group (10.4%).
- The technical failure rate did not differ between the two groups, but adverse events occurred more often after ESD (36%) than EMR (24.5%).
IN PRACTICE:
"Patients and physicians should be aware of these study results, not only to know when to choose endoscopic resection instead of surgery but also to choose the endoscopic resection strategy that best fits the patient according to the lesion, the acceptance of follow-up colonoscopy, and the available expertise at the center," the authors wrote.
SOURCE:
Jérémie Jacques, MD, PhD, Service d'Hépato-Gastro-Entérologie, Limoges, France, led the study, which was published online in the Annals of Internal Medicine on December 11, 2023.
LIMITATIONS:
Procedures were performed on an inpatient basis under general anesthesia, which is governed by French regulations, and the authors do not know whether safety issues would vary in different organizational settings using deep sedation and/or treatment as outpatients. The lack of reimbursement for ESD in several Western countries prevents generalization of the results.
DISCLOSURES:
The study is supported by the French Ministry of Health and was funded by a French Protocole Hospitalier de Recherche Clinique National public grant. The author disclosures can be found with the original article.
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