Clinical trial · Observational
Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia
Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective observational cohort study aims to compare the clinical and procedural outcomes of Endoscopic Submucosal Dissection (ESD) and Transanal Minimally Invasive Surgery (TAMIS) for the treatment of early-stage rectal neoplasia. The study will evaluate recurrence rates, en bloc resection rates, R0 resection rates, procedure time, complication rates, and length of hospital stay over a 1-year follow-up period. Data will be collected from patients treated at multiple centers with expertise in ESD and TAMIS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Submucosal Dissection (ESD) | Procedure | — | UNRESOLVED |
| Transanal Endoscopic Surgery (TES) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Endoscopic submucosal dissection (ESD)
- description
- Patients who underwent excision with endoscopic submucosal dissection
- interventionNames
- Procedure: Endoscopic Submucosal Dissection (ESD)
- label
- Transanal endoscopic surgery (TES)
- description
- Patients who underwent excision with transanal endoscopic surgery
- interventionNames
- Procedure: Transanal Endoscopic Surgery (TES)
Primary outcomes (2)
- measure
- R0 Resection Rate
- timeFrame
- Immediately post-procedure.
- description
- Proportion of patients with histologically confirmed tumor-free margins. All pathological evaluations will be performed according to the College of American Pathologists (CAP) protocol (version 4.3.0.0, 2023)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>18 years) * Non-pedunculated (sessile) lesions larger than 2 cm. * Lesions located within 15 cm from the anal verge confirmed by sigmoidoscopy or magnetic resonance imaging (MRI) Exclusion Criteria: * Evidence of lymph node involvement, T2 rectal tumors, or distant metastasis on preoperative imaging modalities (MRI, ERUS, CT) * Previous attempt at endoscopic resection * Previous rectal surgery * Previous pelvic radiation therapy * Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)
References
Publications (1)
- BACKGROUNDde Sousa IVG, Bestetti AM, Cadena-Aguirre DP, Kum AST, Mega PF, da Silva PHVA, Miyajima NT, Bernardo WM, de Moura EGH. Comparison of endoscopic submucosal dissection and transanal endoscopic surgery for the treatment of rectal neoplasia: A systematic review and meta-analysis. Clinics (Sao Paulo). 2025 Mar 13;80:100613. doi: 10.1016/j.clinsp.2025.100613. eCollection 2025. PMID 40086369