Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias

NCT03959839 | Completed

• 1 other identifier: DSETAMIS-2018
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

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

Rectal Neoplasms

Keywords

Early Rectal Neoplasms; ESD; TAMIS; TEO; Recurrence; R0; Safety

Outcome Measures

Primary Outcomes (1)

• local recurrence rate

  presence of remaining neoplastic tissue in resection site

  12 months

Secondary Outcomes (9)

• En-bloq resection rate

  1 hour

• R0 resection rate

  1 hour

• Time per procedure

  1 hour

• Length of hospital stay

  1 hour

• Early complications rate

  1 hour

Study Arms (2)

Endoscopic Treatment

EXPERIMENTAL

Rectal Endoscopic Submucosal Dissection

Procedure: ESD

Minimally Invasive Laparoscopic Local Surgical Treatment

EXPERIMENTAL

Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)

Procedure: TAMIS; Procedure: TEO

Interventions

ESD PROCEDURE

Rectal Endoscopic Submucosal Dissection

Endoscopic Treatment

TAMIS PROCEDURE

Transanal Minimally Invasive Surgery

Minimally Invasive Laparoscopic Local Surgical Treatment

TEO PROCEDURE

Transanal Endoscopic Operation

Minimally Invasive Laparoscopic Local Surgical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Alberto Herreros de Tejada Echanojáuregui: lead
• Spanish Society of Digestive Endoscopy: collaborator

Study Sites (3)

Hospital de Sant Joan Despí Moisès Broggi

Barcelona, Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Related Publications (1)

• de 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 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Recurrence

Interventions

Transanal Endoscopic Surgery

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Natural Orifice Endoscopic Surgery; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Proctoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Eduardo Albéniz, MD, PhD

  Complejo Hospitalario de Navarra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 22, 2019
• Study Start: April 1, 2019
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)