Rectal NeoplasmsDSETAMIS2018NCT03959839
Endoscopic Submucosal Dissection vs Local Laparoscopic Surgical Resection (TAMIS/TEO) in Early Rectal Neoplasias
A study testing ESD, TAMIS and TEO in people with Rectal Neoplasms, run by Dr. Alberto Herreros de Tejada Echanojáuregui at 3 sites in Spain.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- ESD, TAMIS and TEO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Apr 2019to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital de Sant Joan Despí Moisès Broggi
Barcelona, Barcelona
Hospital General Universitario Gregorio Marañón
Madrid, Madrid
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
About this study
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
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.
Read the 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.
- Conditions
- Rectal Neoplasms
- Being tested
- ESD, TAMIS, TEO
- Keywords
- Early Rectal Neoplasms, ESD, TAMIS, TEO, Recurrence, R0, Safety
- Medical subject headings
- Rectal Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESDProcedure or surgery
Rectal Endoscopic Submucosal Dissection
TAMISProcedure or surgery
Transanal Minimally Invasive Surgery
TEOProcedure or surgery
Transanal Endoscopic Operation
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Treatment | Experimental | Rectal Endoscopic Submucosal Dissection Receives: Procedure: ESD |
| Minimally Invasive Laparoscopic Local Surgical Treatment | Experimental | Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO) Receives: Procedure: TAMIS; Procedure: TEO |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence rate
presence of remaining neoplastic tissue in resection site
Measured: 12 months
Secondary outcomes (9)
En-bloq resection rate
Single piece of resection specimen
Measured: 1 hour
R0 resection rate
Free margin of neoplastic tissue both laterally and deep
Measured: 1 hour
Time per procedure
The length of the procedure expressed in minutes
Measured: 1 hour
Length of hospital stay
Days of hospital stay
Measured: 1 hour
Early complications rate
Registration of any deviations on the normal postoperative period in the first 24 hours
Measured: 1 hour
Delayed complications rate
Registration of any deviations on the normal postoperative period after the first 24 hours and up to 30 days after the procedure
Measured: 1 hour
Morbidity
Changes in patients' quality of life using validated scores (both, specific and non-specific)
Measured: 12 months
Cost-effectiveness analyses (QALY)
Cost-effectiveness analyses usin QALYs
Measured: 12 months
Short-term local recurrence rate
Presence of remaining neoplastic tissue in resection site
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Apr 2019
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Alberto Herreros de Tejada Echanojáuregui
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy
- Responsible party
- Sponsor-investigator, Dr. Alberto Herreros de Tejada Echanojáuregui, Puerta de Hierro University Hospital
- Investigators
- Eduardo Albéniz, MD, PhD, Study director, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959839
- Sponsor's protocol ID
- DSETAMIS-2018
- Acronym
- DSETAMIS2018
- Status last verified
- May 2025
- First submitted
- 16 May 2019
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40749854
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03959839
- Acronym / sponsor ID
- DSETAMIS2018 / DSETAMIS-2018
- Conditions
- Rectal Neoplasms
- Keywords
- Early Rectal Neoplasms, ESD, TAMIS, TEO, Recurrence, R0, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dr. Alberto Herreros de Tejada EchanojáureguiUniversity, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Treatment | Experimental | Procedure: ESDRectal Endoscopic Submucosal Dissection |
| Minimally Invasive Laparoscopic Local Surgical Treatment | Experimental | Procedure: TAMIS, Procedure: TEOTransanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESDRectal Endoscopic Submucosal Dissection | Procedure or surgery | Endoscopic Treatment |
| TAMISTransanal Minimally Invasive Surgery | Procedure or surgery | Minimally Invasive Laparoscopic Local Surgical Treatment |
| TEOTransanal Endoscopic Operation | Procedure or surgery | Minimally Invasive Laparoscopic Local Surgical Treatment |
Primary outcome
local recurrence rate
Time frame: 12 months
presence of remaining neoplastic tissue in resection site
9 secondary outcomes
En-bloq resection rate
Time frame: 1 hour
R0 resection rate
Time frame: 1 hour
Time per procedure
Time frame: 1 hour
Length of hospital stay
Time frame: 1 hour
Early complications rate
Time frame: 1 hour
Delayed complications rate
Time frame: 1 hour
Morbidity
Time frame: 12 months
Cost-effectiveness analyses (QALY)
Time frame: 12 months
Short-term local recurrence rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Derived from this study: PubMed 40749854de 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.
- Individual participant dataSharing planned: No
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Albéniz, MD, PhD study director
Complejo Hospitalario de Navarra
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESD, TAMIS and TEO in people with Rectal Neoplasms, run by Dr. Alberto Herreros de Tejada Echanojáuregui at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.