Clinical trial · Interventional
Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias
Endoscopic Submucosal Dissection Versus Local Laparoscopic Surgical Resection (Transanal Minimally Invasive Surgery [TAMIS] / Transanal Endoscopic Operation [TEO]) In Early Rectal Neoplasias. Multicentric and Randomized Clinical Trial
- 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)
A multicenter non-inferiority randomized clinical trial to compare Endoscopic treatment (ESD) and Minimally Invasive Laparoscopic Local Surgical Treatment (TAMIS or TEO) for early rectal neoplastic lesions (adenoma \& T1CRC) Primary aim: To compare the long-term local recurrence rate (12 months after the procedure) Secondary aims: Compare en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate, safety (rate of complications), morbidity and cost-effectiveness analyses.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESD | Procedure | — | UNRESOLVED |
| TAMIS | Procedure | — | UNRESOLVED |
| TEO | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endoscopic Treatment
- description
- Rectal Endoscopic Submucosal Dissection
- interventionNames
- Procedure: ESD
- type
- EXPERIMENTAL
- label
- Minimally Invasive Laparoscopic Local Surgical Treatment
- description
- Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)
- interventionNames
- Procedure: TAMIS
- Procedure: TEO
Primary outcomes (1)
- measure
- local recurrence rate
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 y/o * Non-pedunculated rectal lesions (sessile 0-Is or flat 0-II) greater than 20 mm in diameter. * The edges of the lesion should be more than 3 cm from the external anal margin and up to 14 cm from it. * Circumferential involvement \<50% Exclusion Criteria: * Patients who refuse to participate. * Diagnosis of inflammatory bowel disease with rectal involvement. * Pregnant. * Anorectal fibrosis due to previous anorectal surgery. * Lateral Spreading Lesions (LST classification) Granular Homogeneous type * Lesions greater than 50 mm when there is suspicion of advanced histology (Kudo Vi superficial pattern). * Rectal lesions of any size with high suspicion of deep submucosal invasion or locoregional lymph node involvement, either in the diagnostic colonoscopy (Kudo Vn pit pattern, NICE 3 pattern, Sano IIIB pattern) or by complementary imaging tests (rectal EUS/Pelvic MRI) * Existence of synchronous colorectal lesions that require other surgical treatment in any case.
References
Publications (1)
- DERIVEDde Frutos Rosa D, Alonso Sebastian I, Barquero Declara D, Badia Closa J, Nogales O, Jimenez Gomez LM, Santiago Garcia J, Valentin Gomez F, Royuela Vicente A, Sanchez Movilla A, Albeniz E, Herreros de Tejada Echanojauregui A; Mucosal Resection; Third-Space Endoscopy Working Group from the Spanish Society of Gastrointestinal Endoscopy. A Randomized Trial of Endoscopic Submucosal Dissection vs Transanal Minimally Invasive Surgery in Early Rectal Neoplasms: DSETAMIS-2018 Study. Gastroenterology. 2026 Jan;170(1):161-173. doi: 10.1053/j.gastro.2025.07.029. Epub 2025 Jul 30. PMID 40749854