An interventional study of Endoscopic mucosal resection (EMR) and Endoscopic submucosal dissection (ESD) in Neoplasms, Colorectal, sponsored by José Carlos Marín Gabriel. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by José Carlos Marín Gabriel · Not applicable, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 236 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with José Carlos Marín Gabriel as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Piecemeal 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)
Procedure: Endoscopic mucosal resection (EMR)
ESD 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.
Procedure: Endoscopic submucosal dissection (ESD)
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) 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.
Percentage of surgical referral after treatment
Compare between two groups.
Time frame: Month 18
En bloc resection rate
Compare between two groups
Time frame: Month 1
R0 resection rate
Compare between two groups
Time frame: Month 1
Duration of the procedure
Compare between two groups
Time frame: Month 1
Percentage of curative resection rates without surgery
Compare between two groups
Time frame: Month 18
Proportion of cases in which the endoscopist has to change technique to the alternative procedure
Compare between two groups
Time frame: Month 1
Cumulative complications rate after treatment
Compare between two groups
Time frame: Month 1 and 18
Plan to share: No
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.