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

NCT04593407 | Recruiting

• 1 other identifier: intERsection-19/281
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neoplasms, Colorectal

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

Outcome Measures

Primary Outcomes (1)

• Percentage of surgical referral after treatment

  Compare between two groups.

  Month 18

Secondary Outcomes (6)

• En bloc resection rate

  Month 1

• R0 resection rate

  Month 1

• Duration of the procedure

  Month 1

• Percentage of curative resection rates without surgery

  Month 18

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

  Month 1

Study Arms (2)

Endoscopic Mucosal Resection (EMR):

ACTIVE COMPARATOR

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)

: Endoscopic Submucosal Dissection (ESD):

EXPERIMENTAL

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)

Interventions

Endoscopic mucosal resection (EMR) PROCEDURE

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 Mucosal Resection (EMR):

Endoscopic submucosal dissection (ESD) PROCEDURE

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.

: Endoscopic Submucosal Dissection (ESD):

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients able to fill in questionnaires written in Spanish or English.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• José Carlos Marín Gabriel: lead
• Spanish Society of Digestive Endoscopy: collaborator

Study Sites (1)

Hospital Universitario "12 de Octubre"

Madrid, 28041, Spain

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps; Adenoma; Polyps; Pathological Conditions, Anatomical; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• José C. Marín-Gabriel, Assoc. Prof.

  Hospital Universitario 12 de Octubre

  STUDY DIRECTOR

Central Study Contacts

José C. Marín-Gabriel, Assoc. Prof.

CONTACT

+34 91 779 28 27; josecarlos.marin@salud.madrid.org

Esperanza Ulloa-Márquez

CONTACT

+34 91 779 28 27; esperanza.ulloa@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: November 3, 2020
• Primary Completion: May 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)