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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

Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
local recurrence rate [ Time Frame: 12 months ]
presence of remaining neoplastic tissue in resection site
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • En-bloq resection rate [ Time Frame: 1 hour ]
    Single piece of resection specimen
  • R0 resection rate [ Time Frame: 1 hour ]
    Free margin of neoplastic tissue both laterally and deep
  • Time per procedure [ Time Frame: 1 hour ]
    The length of the procedure expressed in minutes
  • Length of hospital stay [ Time Frame: 1 hour ]
    Days of hospital stay
  • Early complications rate [ Time Frame: 1 hour ]
    Registration of any deviations on the normal postoperative period in the first 24 hours
  • 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
  • Morbidity [ Time Frame: 12 months ]
    Changes in patients' quality of life using validated scores (both, specific and non-specific)
  • Cost-effectiveness analyses (QALY) [ Time Frame: 12 months ]
    Cost-effectiveness analyses usin QALYs
  • Short-term local recurrence rate [ Time Frame: 6 months ]
    Presence of remaining neoplastic tissue in resection site
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias
Official Title  ICMJE 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
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.

Detailed Description

A multicenter non-inferiority randomized clinical trial is proposed to compare two types of treatment for early rectal neoplastic lesions. Study arms:

  1. Endoscopic treatment: Endoscopic Submucosal Dissection (ESD)
  2. Minimally invasive laparoscopic local surgical treatment: Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO).

Aims:

Primary aim: To compare the long-term local recurrence rate (12 months after the procedure) of rectal lesions after ESD vs Surgical treatment (TAMIS/TEO).

Secondary aims: Both arms of the study are compared according to other efficacy-related variables (en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate [6 months]), safety (rate of complications), morbidity (comparing different specific indexes: Wexner index, EQ-5L-5D, etc) and cost-effectiveness analyses (QALY).

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 crypt 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.

N-size estimation:

Assuming a global rate of long-term local recurrence in rectal lesions treated by TAMIS/TEO or ESD of 2.5% (using the data available in the medical literature), considering a non-inferiority limit of 10%, power of 80% (Beta error 0.2, alpha error 0.05) and assuming a loss of patients during the follow-up around 10%, 34 patients per group are required.

Follow-up and Information collect:

The follow-up will be of 1 year from the date of the intervention and the visits in which the information to be analyzed will be collected are adjusted to the usual clinical practice.

The data would be registered using the on-line database system for medical research RedCap.

Other information:

The entire protocol of this study has been approved by de Ethical Committee on Clinical Research of the Puerta de Hierro University Hospital.

The study counts with a Civil Responsibility Insurance policy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Neoplasms
Intervention  ICMJE
  • Procedure: ESD
    Rectal Endoscopic Submucosal Dissection
  • Procedure: TAMIS
    Transanal Minimally Invasive Surgery
  • Procedure: TEO
    Transanal Endoscopic Operation
Study Arms  ICMJE
  • Experimental: Endoscopic Treatment
    Rectal Endoscopic Submucosal Dissection
    Intervention: Procedure: ESD
  • Experimental: Minimally Invasive Laparoscopic Local Surgical Treatment
    Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)
    Interventions:
    • Procedure: TAMIS
    • Procedure: TEO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Diego de Frutos, MD +34600826265 diegodefrutos@gmail.com
Contact: Alberto Herreros de Tejada, MD, PhD alberto.herreros@salud.madrid.org
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959839
Other Study ID Numbers  ICMJE DSETAMIS-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Alberto Herreros de Tejada Echanojáuregui, Puerta de Hierro University Hospital
Study Sponsor  ICMJE Dr. Alberto Herreros de Tejada Echanojáuregui
Collaborators  ICMJE SPANISH SOCIETY OF DIGESTIVE ENDOSCOPY
Investigators  ICMJE
Study Director: Eduardo Albéniz, MD, PhD Complejo Hospitalario de Navarra
PRS Account Puerta de Hierro University Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP