NCT03959839Completed
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 · Last updated 3 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 16 May 2019
- Start date
- 1 Apr 2019
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- Dr. Alberto Herreros de Tejada Echanojáuregui
- Diseases
- Colorectal cancer
- NCT number
- NCT03959839
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 1 Apr 2019 to the primary completion date, 20 Dec 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anorectal fibrosis due to previous anorectal surgery.
- Existence of synchronous colorectal lesions that require other surgical treatment in any case.
Other illness
- Diagnosis of inflammatory bowel disease with rectal involvement.
Other
- Patients who refuse to participate.
- Pregnant.
- 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)
Who the study is looking for
- 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%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Sant Joan Despí - Moises Broggi Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.