- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03959839
Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias (DSETAMIS2018)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A multicenter non-inferiority randomized clinical trial is proposed to compare two types of treatment for early rectal neoplastic lesions. Study arms:
- Endoscopic treatment: Endoscopic Submucosal Dissection (ESD)
- 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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Diego de Frutos, MD
- Phone Number: +34600826265
- Email: diegodefrutos@gmail.com
Study Contact Backup
- Name: Alberto Herreros de Tejada, MD, PhD
- Email: alberto.herreros@salud.madrid.org
Study Locations
-
-
-
Barcelona, Spain
- Not yet recruiting
- Hospital de Sant Joan Despí Moisès Broggi
-
Contact:
- David Barquero
-
Madrid, Spain
- Not yet recruiting
- Hospital General Universitario Gregorio Maranon
-
Contact:
- Oscar Nogales
-
Madrid, Spain
- Not yet recruiting
- Hospital Universitario 12 de Octubre
-
Contact:
- Jose Carlos Marín
-
-
Cantabria
-
Santander, Cantabria, Spain
- Not yet recruiting
- Hospital Universitario Marques de Valdecilla
-
Contact:
- Álvaro Terán
-
-
Madrid
-
Boadilla Del Monte, Madrid, Spain
- Not yet recruiting
- Hospital Universitario HM Monteprincipe
-
Contact:
- Felipe Ramos
-
Majadahonda, Madrid, Spain, 28222
- Recruiting
- Hospital Universitario Puerta de Hierro
-
Contact:
- Diego de Frutos, MD
- Phone Number: 600826265
- Email: diegodefrutos@gmail.com
-
-
Malaga
-
Málaga, Malaga, Spain
- Not yet recruiting
- Hospital Quirónsalud Málaga
-
Contact:
- Pedro Rosón, MD
-
-
Navarra
-
Pamplona, Navarra, Spain, 31008
- Not yet recruiting
- Complejo Hospitalario de Navarra
-
Contact:
- Eduardo Albeniz, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endoscopic Treatment
Rectal Endoscopic Submucosal Dissection
|
Rectal Endoscopic Submucosal Dissection
|
Experimental: Minimally Invasive Laparoscopic Local Surgical Treatment
Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)
|
Transanal Minimally Invasive Surgery
Transanal Endoscopic Operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
local recurrence rate
Time Frame: 12 months
|
presence of remaining neoplastic tissue in resection site
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
En-bloq resection rate
Time Frame: 1 hour
|
Single piece of resection specimen
|
1 hour
|
R0 resection rate
Time Frame: 1 hour
|
Free margin of neoplastic tissue both laterally and deep
|
1 hour
|
Time per procedure
Time Frame: 1 hour
|
The length of the procedure expressed in minutes
|
1 hour
|
Length of hospital stay
Time Frame: 1 hour
|
Days of hospital stay
|
1 hour
|
Early complications rate
Time Frame: 1 hour
|
Registration of any deviations on the normal postoperative period in the first 24 hours
|
1 hour
|
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
|
1 hour
|
Morbidity
Time Frame: 12 months
|
Changes in patients' quality of life using validated scores (both, specific and non-specific)
|
12 months
|
Cost-effectiveness analyses (QALY)
Time Frame: 12 months
|
Cost-effectiveness analyses usin QALYs
|
12 months
|
Short-term local recurrence rate
Time Frame: 6 months
|
Presence of remaining neoplastic tissue in resection site
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Eduardo Albéniz, MD, PhD, Complejo Hospitalario de Navarra
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSETAMIS-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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