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Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias (DSETAMIS2018)

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ClinicalTrials.gov Identifier: NCT03959839
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
SPANISH SOCIETY OF DIGESTIVE ENDOSCOPY
Information provided by (Responsible Party):
Dr. Alberto Herreros de Tejada Echanojáuregui, Puerta de Hierro University Hospital

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.


Condition or disease Intervention/treatment Phase
Rectal Neoplasms Procedure: ESD Procedure: TAMIS Procedure: TEO Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Endoscopic Treatment
Rectal Endoscopic Submucosal Dissection
Procedure: ESD
Rectal Endoscopic Submucosal Dissection

Experimental: Minimally Invasive Laparoscopic Local Surgical Treatment
Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)
Procedure: TAMIS
Transanal Minimally Invasive Surgery

Procedure: TEO
Transanal Endoscopic Operation




Primary Outcome Measures :
  1. local recurrence rate [ Time Frame: 12 months ]
    presence of remaining neoplastic tissue in resection site


Secondary Outcome Measures :
  1. En-bloq resection rate [ Time Frame: 1 hour ]
    Single piece of resection specimen

  2. R0 resection rate [ Time Frame: 1 hour ]
    Free margin of neoplastic tissue both laterally and deep

  3. Time per procedure [ Time Frame: 1 hour ]
    The length of the procedure expressed in minutes

  4. Length of hospital stay [ Time Frame: 1 hour ]
    Days of hospital stay

  5. Early complications rate [ Time Frame: 1 hour ]
    Registration of any deviations on the normal postoperative period in the first 24 hours

  6. Delayed complications rate [ Time Frame: 1 hour ]
    Registration of any deviations on the normal postoperative period after the first 24 hours and up to 30 days after the procedure

  7. Morbidity [ Time Frame: 12 months ]
    Changes in patients' quality of life using validated scores (both, specific and non-specific)

  8. Cost-effectiveness analyses (QALY) [ Time Frame: 12 months ]
    Cost-effectiveness analyses usin QALYs

  9. Short-term local recurrence rate [ Time Frame: 6 months ]
    Presence of remaining neoplastic tissue in resection site



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959839


Contacts
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Contact: Diego de Frutos, MD +34600826265 diegodefrutos@gmail.com
Contact: Alberto Herreros de Tejada, MD, PhD alberto.herreros@salud.madrid.org

Locations
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Spain
Hospital Universitario Marqués de Valdecilla Not yet recruiting
Santander, Cantabria, Spain
Contact: Álvaro Terán         
Hospital Universitario HM Montepríncipe Not yet recruiting
Boadilla Del Monte, Madrid, Spain
Contact: Felipe Ramos         
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Diego de Frutos, MD    600826265    diegodefrutos@gmail.com   
Hospital QuironSalud Málaga Not yet recruiting
Málaga, Malaga, Spain
Contact: Pedro Rosón, MD         
Complejo Hospitalario de Navarra Not yet recruiting
Pamplona, Navarra, Spain, 31008
Contact: Eduardo Albeniz, MD, PhD         
Hospital de Sant Joan Despí Moisès Broggi Not yet recruiting
Barcelona, Spain
Contact: David Barquero         
Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain
Contact: Oscar Nogales         
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain
Contact: Jose Carlos Marín         
Sponsors and Collaborators
Dr. Alberto Herreros de Tejada Echanojáuregui
SPANISH SOCIETY OF DIGESTIVE ENDOSCOPY
Investigators
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Study Director: Eduardo Albéniz, MD, PhD Complejo Hospitalario de Navarra

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Responsible Party: Dr. Alberto Herreros de Tejada Echanojáuregui, Principal Investigator, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT03959839     History of Changes
Other Study ID Numbers: DSETAMIS-2018
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Alberto Herreros de Tejada Echanojáuregui, Puerta de Hierro University Hospital:
Early Rectal Neoplasms
ESD
TAMIS
TEO
Recurrence
R0
Safety

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases