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Neoplasms, ColorectalintERsectionNCT04593407

Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.

A study testing Endoscopic mucosal resection (EMR) and Endoscopic submucosal dissection (ESD) in people with Neoplasms, Colorectal, run by José Carlos Marín Gabriel at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

EMR and ESD are both effective and safe and are associated with a very low risk of procedure related mortality when performed for colorectal laterally spreading lesions (LSL). Some kind of LSLs have a low risk of submucosal invasive carcinoma (SMIC) or these foci are found in well demarcated areas of the tumor. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Neoplasms, Colorectal
What is being tested?
Endoscopic mucosal resection (EMR) and Endoscopic submucosal dissection (ESD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
1 siteSpain
Study dates
1 Dec 2020to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (at least 18 years old).
  • LSL-NG FE type ≥ 20mm or LST-G mixed type ≥30mm who have not been previously treated or received submucosal injection, regardless of their location in the colon.
  • LSL-NG FE type ≥ 20mm or LST-G mixed type ≥30mm WITHOUT a demarcated area
  • The patient must have undergone a complete colonoscopy, reaching the cecum, to detect possible synchronous lesion. If this procedure has not been done previously, it will be performed prior to the inclusion of the patient in the study.
  • Patients able to fill in questionnaires written in Spanish or English.

Who cannot join

  • Contra-indication to colonoscopy.
  • Contra-indication to general anesthesia.
  • Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
  • Patients with > 1 lesion meeting the inclusion criteria.
  • LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type that have been previously treated (Recurrence or residual lesion after previous endoscopic or surgical treatment).
  • LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type with previous submucosal injection, even if a resection attempt with a snare was not finally performed.
Show all 21Show fewer
  • Lesions with suspicion of deep submucosal invasive carcinoma: depression or invasive pit-pattern (Vi within a demarcated area or Vn).
  • Submucosal mass like elevation within a LSL-NG FE type.
  • LSLs having a previous biopsy or tattooing. Previous biopsies of the lesion should only be allowed if LSL-G mixed type > 30 mm and samples were taken out of the flat area.
  • LSL-G with a Buddha like deformation (Polyp on polyp)
  • LSL involving a surgical anastomosis.
  • LSL involving the appendicular orifice.
  • LSL involving the terminal ileum.
  • Patient's refusal to participate in the study
  • Presence of inflammatory bowel disease
  • Pregnant or lactating women.
  • Hereditary colorectal cancer syndrome or hereditary polyposis.
  • Patient under legal protection and or deprived of liberty by judicial or administrative decision.
  • Patient already participating in an interventional clinical research protocol
  • Patient who cannot be followed for the duration of the study.
  • Inability to sign the informed consent of the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario "12 de Octubre"

    Madrid, 28041

Other trials in Spain

About this study

Official title: Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Laterally Spreading Lesions Non Granular-Flat Elevated Type (LSL-NG-FE) ≥ 20 mm and LSLs-Granular Mixed Type ≥ 30 mm. A Randomized, Non-inferiority Trial.

EMR and ESD are both effective and safe and are associated with a very low risk of procedure related mortality when performed for colorectal laterally spreading lesions (LSL).

Some kind of LSLs have a low risk of submucosal invasive carcinoma (SMIC) or these foci are found in well demarcated areas of the tumor. This is the case of the non-granular flat elevated (LSN-NG-FE) and the LSLs-G mixed subtypes.

The investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type > 30 mm and LSLs-NG FE type > 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.

Read the detailed description

Endoscopic submucosal dissection (ESD) is curative for lesions with superficial submucosal invasive carcinoma (s-SMIC) and favourable histological features. The procedure is performed mainly for laterally spreading lesions (LSLs) and is the reference treatment for these neoplasms in Asian countries nowadays. LSLs can be granular (G) or non-granular (NG). Most LSLs-G homogenous type are superficial and can be resected by EMR because SMIC is often lacking. On the other hand, since LSLs-G mixed type > 20 - 30 mm have a higher prevalence of SMIC when compared with the homogenous subtype, Asian experts now recommend ESD for this kind of tumors. However, some years ago, EMR had been suggested for LSLs-G mixed type if the largest nodule was resected first and the histological assessment was done separately. The rationale for the latter approach is that the invasive component is usually found within the large nodule.

Conversely, the prevalence of SMIC is higher in LSLs-NG PD type, therefore, ESD is the preferred therapeutic intervention. In addition, LSLs-NG FE type have been associated with multifocal invasion in Japanese studies. However, in Western countries, the percentage of SMIC in LSLs-NG FE type > 20 mm seems much lower than previously described in Asian series. Thus, the investigators do not know if EMR might be enough to remove these tumours.

Furthermore, if the risk of s-SMIC is low, the recurrence rates for ESD in these kind of lesions (LSL-G mixed type > 30 mm and LSL-NG FE type > 20 mm) might be comparable to that of piecemeal EMR, in terms of curative resection (avoiding the need for surgery) in the mid-term. When performing an EMR, recurrences are more frequent, but they are largely inconsequential because it is usually unifocal, diminutive and easily can be managed endoscopically on subsequent sessions.

In order to clarify the controversial issue of performing colorectal ESD in Western countries, the investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type > 30 mm and LSLs-NG FE type > 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.

Being tested
Endoscopic mucosal resection (EMR), Endoscopic submucosal dissection (ESD)
Keywords
Colonic Polyps, large laterally spreading lesion, colonic adenoma, Endoscopic submucosal dissection, Endoscopic Mucosal Resection, Adenoma, Polyps, Pathological Conditions, Anatomical, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Intestinal Polyps
Medical subject headings
Colorectal Neoplasms, Colonic Polyps, Adenoma, Polyps, Pathological Conditions, Anatomical, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic mucosal resection (EMR)Procedure or surgery

    Endoscopic mucosal resection (EMR) is an endoscopic resection technique that allows the removal of large colorectal lesions using a conventional "lift-and-cut" procedure or an underwater technique

  • Endoscopic submucosal dissection (ESD)Procedure or surgery

    Endoscopic submucosal dissection (ESD) is an endoscopic procedure that allows dissection of larger colorectal lesions in one piece using endoknives.

    The procedure is technically more difficult, much more time-consuming than EMR, mandates multiday hospital admission and has an increased risk of perforation.

Study groups in NCT04593407
Study groupRoleWhat they receive
Endoscopic Mucosal Resection (EMR):Active comparatorPiecemeal EMR is a conventional endoscopic resection technique. A submucosal injection of a large volume of a solution (normal saline or other) with or without dilute epinephrine (1/10,000) with or without indigo carmine is performed. Then, sequential piecemeal resection is performed with use of a combination of stiff-type snares. At the end of the procedure when macroscopically visible adenoma has been totally resected, a snare tip soft coagulation (STSC) of the margin of the scar is performed to eliminate non visible residual neoplastic tissue. This procedure is quicker and safer than ESD but led to more recurrent disease (around 20% with the standard technique but recently reduced to 5% after the introduction of STSC)
Receives: Procedure: Endoscopic mucosal resection (EMR)
: Endoscopic Submucosal Dissection (ESD):ExperimentalESD is a newer resection technique that allows en bloc resection for large LSLs. A submucosal injection is also needed but, in this case, different endo-knives are used to achieve the resection instead of diathermic snares. The en bloc resection allows a more precise pathological analysis and the risk of recurrence is lower (<2%) when margins are tumor-free.
Receives: Procedure: Endoscopic submucosal dissection (ESD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of surgical referral after treatment

    Compare between two groups.

    Measured: Month 18

Secondary outcomes (6)

  1. En bloc resection rate

    Compare between two groups

    Measured: Month 1

  2. R0 resection rate

    Compare between two groups

    Measured: Month 1

  3. Duration of the procedure

    Compare between two groups

    Measured: Month 1

  4. Percentage of curative resection rates without surgery

    Compare between two groups

    Measured: Month 18

  5. Proportion of cases in which the endoscopist has to change technique to the alternative procedure

    Compare between two groups

    Measured: Month 1

  6. Cumulative complications rate after treatment

    Compare between two groups

    Measured: Month 1 and 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start1 Dec 2020
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

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
Single blind
Who is masked
Participant
Enrolment
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04593407
Sponsor's protocol ID
intERsection-19/281
Acronym
intERsection
Status last verified
Sep 2026
First submitted
13 Oct 2020
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burgess NG, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, Mahajan H, McLeod D, Bourke MJ. Risk Stratification for Covert Invasive Cancer Among Patients Referred for Colonic Endoscopic Mucosal Resection: A Large Multicenter Cohort. Gastroenterology. 2017 Sep;153(3):732-742.e1. doi: 10.1053/j.gastro.2017.05.047. Epub 2017 Jun 2.

    PubMed 28583826

  • Uraoka T, Saito Y, Matsuda T, Ikehara H, Gotoda T, Saito D, Fujii T. Endoscopic indications for endoscopic mucosal resection of laterally spreading tumours in the colorectum. Gut. 2006 Nov;55(11):1592-7. doi: 10.1136/gut.2005.087452. Epub 2006 May 8.

    PubMed 16682427

  • Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.

    PubMed 24986245

  • Albeniz E, Pellise M, Gimeno-Garcia AZ, Lucendo AJ, Alonso-Aguirre PA, Herreros de Tejada A, Alvarez MA, Fraile M, Herraiz Bayod M, Lopez Roses L, Martinez Ares D, Ono A, Parra Blanco A, Redondo E, Sanchez-Yague A, Soto S, Diaz-Tasende J, Montes Diaz M, Rodriguez-Tellez M, Garcia O, Zuniga Ripa A, Hernandez Conde M, Alberca de Las Parras F, Gargallo CJ, Saperas E, Munoz Navas M, Gordillo J, Ramos Zabala F, Echevarria JM, Bustamante M, Gonzalez-Haba M, Gonzalez-Huix F, Gonzalez-Suarez B, Vila Costas JJ, Guarner Argente C, Mugica F, Cobian J, Rodriguez Sanchez J, Lopez Viedma B, Pin N, Marin Gabriel JC, Nogales O, de la Pena J, Navajas Leon FJ, Leon Brito H, Remedios D, Esteban JM, Barquero D, Martinez Cara JG, Martinez Alcala F, Fernandez-Urien I, Valdivielso E. Clinical guidelines for endoscopic mucosal resection of non-pedunculated colorectal lesions. Rev Esp Enferm Dig. 2018 Mar;110(3):179-194. doi: 10.17235/reed.2018.5086/2017.

    PubMed 29421912

  • Yang D, Othman M, Draganov PV. Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection For Barrett's Esophagus and Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2019 May;17(6):1019-1028. doi: 10.1016/j.cgh.2018.09.030. Epub 2018 Sep 26.

    PubMed 30267866

  • Fujiya M, Tanaka K, Dokoshi T, Tominaga M, Ueno N, Inaba Y, Ito T, Moriichi K, Kohgo Y. Efficacy and adverse events of EMR and endoscopic submucosal dissection for the treatment of colon neoplasms: a meta-analysis of studies comparing EMR and endoscopic submucosal dissection. Gastrointest Endosc. 2015 Mar;81(3):583-95. doi: 10.1016/j.gie.2014.07.034. Epub 2015 Jan 13.

    PubMed 25592748

  • Arezzo A, Passera R, Marchese N, Galloro G, Manta R, Cirocchi R. Systematic review and meta-analysis of endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal lesions. United European Gastroenterol J. 2016 Feb;4(1):18-29. doi: 10.1177/2050640615585470. Epub 2015 May 5.

    PubMed 26966519

  • Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.

    PubMed 21392504

  • Wang J, Zhang XH, Ge J, Yang CM, Liu JY, Zhao SL. Endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal tumors: a meta-analysis. World J Gastroenterol. 2014 Jul 7;20(25):8282-7. doi: 10.3748/wjg.v20.i25.8282.

    PubMed 25009404

  • Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.

    PubMed 24671869

  • Uraoka T, Parra-Blanco A, Yahagi N. Colorectal endoscopic submucosal dissection in Japan and Western countries. Dig Endosc. 2012 May;24 Suppl 1:80-3. doi: 10.1111/j.1443-1661.2012.01279.x.

    PubMed 22533758

  • Oyama T, Yahagi N, Ponchon T, Kiesslich T, Berr F. How to establish endoscopic submucosal dissection in Western countries. World J Gastroenterol. 2015 Oct 28;21(40):11209-20. doi: 10.3748/wjg.v21.i40.11209.

    PubMed 26523097

  • Repici A, Hassan C, De Paula Pessoa D, Pagano N, Arezzo A, Zullo A, Lorenzetti R, Marmo R. Efficacy and safety of endoscopic submucosal dissection for colorectal neoplasia: a systematic review. Endoscopy. 2012 Feb;44(2):137-50. doi: 10.1055/s-0031-1291448. Epub 2012 Jan 23.

    PubMed 22271024

  • Emmanuel A, Gulati S, Burt M, Hayee B, Haji A. Colorectal endoscopic submucosal dissection: patient selection and special considerations. Clin Exp Gastroenterol. 2017 Jul 13;10:121-131. doi: 10.2147/CEG.S120395. eCollection 2017.

    PubMed 28761366

  • Oka S, Tanaka S, Kanao H, Oba S, Chayama K. Therapeutic strategy for colorectal laterally spreading tumor. Dig Endosc. 2009 Jul;21 Suppl 1:S43-6. doi: 10.1111/j.1443-1661.2009.00869.x.

    PubMed 19691733

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic mucosal resection (EMR) and Endoscopic submucosal dissection (ESD) in people with Neoplasms, Colorectal, run by José Carlos Marín Gabriel at 1 site 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 5 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of surgical referral after treatment (time frame: Month 18). 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 NCT04593407, which also lists 26 linked publications.

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 18 Sep 2026.

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