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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Spain

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:

  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.

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 groups in NCT03959839
Study groupRoleWhat they receive
Endoscopic TreatmentExperimentalRectal Endoscopic Submucosal Dissection
Receives: Procedure: ESD
Minimally Invasive Laparoscopic Local Surgical TreatmentExperimentalTransanal 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.

  1. local recurrence rate

    presence of remaining neoplastic tissue in resection site

    Measured: 12 months

Secondary outcomes (9)

  1. En-bloq resection rate

    Single piece of resection specimen

    Measured: 1 hour

  2. R0 resection rate

    Free margin of neoplastic tissue both laterally and deep

    Measured: 1 hour

  3. Time per procedure

    The length of the procedure expressed in minutes

    Measured: 1 hour

  4. Length of hospital stay

    Days of hospital stay

    Measured: 1 hour

  5. Early complications rate

    Registration of any deviations on the normal postoperative period in the first 24 hours

    Measured: 1 hour

  6. 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

  7. Morbidity

    Changes in patients' quality of life using validated scores (both, specific and non-specific)

    Measured: 12 months

  8. Cost-effectiveness analyses (QALY)

    Cost-effectiveness analyses usin QALYs

    Measured: 12 months

  9. 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.

  1. First posted22 May 2019
  2. Study start1 Apr 2019
  3. Primary completion20 Dec 2024
  4. Study completion20 Dec 2024

Resources

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)
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

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.

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