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CompletedNCT03959839DSETAMIS2018Updated Jun 3, 2025

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

An interventional study of ESD and TAMIS in Rectal Neoplasms, sponsored by Dr. Alberto Herreros de Tejada Echanojáuregui. Completed at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Dr. Alberto Herreros de Tejada Echanojáuregui · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Rectal Neoplasms

Keywords

  • Early Rectal Neoplasms
  • ESD
  • TAMIS
  • TEO
  • Recurrence
  • R0
  • Safety
03

In context

Rectal Neoplasms

2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.

This study's enrollment of 70 is close to the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Dr. Alberto Herreros de Tejada Echanojáuregui is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Endoscopic Treatment

    Rectal Endoscopic Submucosal Dissection

    Procedure: ESD

  • Experimental
    Minimally Invasive Laparoscopic Local Surgical Treatment

    Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO)

    Procedure: TAMIS · Procedure: TEO

Interventions

  • ProcedureESD

    Rectal Endoscopic Submucosal Dissection

  • ProcedureTAMIS

    Transanal Minimally Invasive Surgery

  • ProcedureTEO

    Transanal Endoscopic Operation

06

What researchers measure

Primary outcomes

  1. local recurrence rate

    presence of remaining neoplastic tissue in resection site

    Time frame: 12 months

Secondary outcomes

  1. En-bloq resection rate

    Single piece of resection specimen

    Time frame: 1 hour

  2. R0 resection rate

    Free margin of neoplastic tissue both laterally and deep

    Time frame: 1 hour

  3. Time per procedure

    The length of the procedure expressed in minutes

    Time frame: 1 hour

  4. Length of hospital stay

    Days of hospital stay

    Time frame: 1 hour

  5. Early complications rate

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

    Time frame: 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

    Time frame: 1 hour

  7. Morbidity

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

    Time frame: 12 months

  8. Cost-effectiveness analyses (QALY)

    Cost-effectiveness analyses usin QALYs

    Time frame: 12 months

  9. Short-term local recurrence rate

    Presence of remaining neoplastic tissue in resection site

    Time frame: 6 months

07

Study locations

3 sites
  • Hospital Universitario Puerta de Hierro
    Majadahonda, Madrid 28222, Spain
  • Hospital de Sant Joan Despí Moisès Broggi
    Barcelona, Spain
  • Hospital General Universitario Gregorio Marañón
    Madrid, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Dec 2024, 68 months.

Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's 68 months is above that.

Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2019
First posted
May 22, 2019
StartActual
Apr 1, 2019
Primary completionActual
Dec 20, 2024
CompletionActual
Dec 20, 2024
Last update
Jun 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03959839
Lead sponsor
Dr. Alberto Herreros de Tejada Echanojáuregui
Collaborators
Spanish Society of Digestive Endoscopy
Responsible party
Dr. Alberto Herreros de Tejada Echanojáuregui (Principal Investigator, Puerta de Hierro University Hospital) — Sponsor-investigator
First posted
May 22, 2019
Start date
Apr 1, 2019
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024
Last update
Jun 3, 2025

Study contacts

Eduardo Albéniz, MD, PhD
study director · Complejo Hospitalario de Navarra

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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