Clinical trial · Interventional
ESD Versus TAMIS for Early Rectal Neoplasms
Endoscopic Submucosal Dissection (ESD) Versus Transanal Minimally Invasive Surgery (TAMIS) for Early Rectal Neoplasms: a Prospective Randomized Controlled Trial
NCT03217773CI-TRIAL-00040654unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms.
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 |
|---|---|---|---|
| ESD | Procedure | — | UNRESOLVED |
| TAMIS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ESD
- description
- ESD is an endoscopic procedure that enables en bloc resection of large tumors in the gastrointestinal tract, irrespective of the size of the lesion. ESD uses an electrosurgical cutting device to purposely dissect the deeper layers of the submucosa to remove neoplastic mucosal lesions in a single piece.
- interventionNames
- Procedure: ESD
- type
- ACTIVE_COMPARATOR
- label
- TAMIS
- description
- TAMIS is a minimally invasive means of removing large rectal neoplastic lesions not accessible by conventional transanal excision. It is performed using the GelPOINT path transanal access platform and laparoscopic instruments.
- interventionNames
- Procedure: TAMIS
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with nonpedunculated early rectal neoplasms \>/= 2 cm in size in the rectum (\>/= 3 cm and \</= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or EMR as judged by two experienced endoscopist * Age of patients \>18 years; * American Society of Anesthesiologists (ASA) grading I-III * Informed consent available Exclusion Criteria: * Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB) * Evidence of deep invasion on endorectal ultrasonography * Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion) * Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection * Patients with recurrence from previous Endoscopic Mucosal Resection or ESD * Patients with known metastatic disease * Patients with non-correctable coagulopathy
References
Publications (0)
Data not yet available
No reference posted for this study.