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

Primary Purpose

Neoplasms, Colorectal

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Endoscopic mucosal resection (EMR)

Endoscopic submucosal dissection (ESD)

About this trial

This is an interventional treatment trial for Neoplasms, Colorectal focused on measuring 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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Hospital Universitario "12 de Octubre"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Endoscopic Mucosal Resection (EMR):

: Endoscopic Submucosal Dissection (ESD):

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Percentage of surgical referral after treatment

Compare between two groups.

Secondary Outcome Measures

En bloc resection rate

Compare between two groups

R0 resection rate

Compare between two groups

Duration of the procedure

Compare between two groups

Percentage of curative resection rates without surgery

Compare between two groups

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

Compare between two groups

Cumulative complications rate after treatment

Compare between two groups

Full Information

NCT ID

NCT04593407

First Posted

October 13, 2020

Last Updated

September 26, 2023

Sponsor

José Carlos Marín Gabriel

Collaborators

Spanish Society of Digestive Endoscopy

1. Study Identification

Unique Protocol Identification Number

NCT04593407

Brief Title

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

Acronym

intERsection

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 3, 2020 (Actual)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

José Carlos Marín Gabriel

Collaborators

Spanish Society of Digestive Endoscopy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

376 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic Mucosal Resection (EMR):

Arm Type

Active Comparator

Arm Description

Arm Title

: Endoscopic Submucosal Dissection (ESD):

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Endoscopic mucosal resection (EMR)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Endoscopic submucosal dissection (ESD)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of surgical referral after treatment

Description

Compare between two groups.

Time Frame

Month 18

Secondary Outcome Measure Information:

Title

En bloc resection rate

Description

Compare between two groups

Time Frame

Month 1

Title

R0 resection rate

Description

Compare between two groups

Time Frame

Month 1

Title

Duration of the procedure

Description

Compare between two groups

Time Frame

Month 1

Title

Percentage of curative resection rates without surgery

Description

Compare between two groups

Time Frame

Month 18

Title

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

Description

Compare between two groups

Time Frame

Month 1

Title

Cumulative complications rate after treatment

Description

Compare between two groups

Time Frame

Month 1 and 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

José C. Marín-Gabriel, Assoc. Prof.

Phone

+34 91 779 28 27

josecarlos.marin@salud.madrid.org

First Name & Middle Initial & Last Name or Official Title & Degree

Esperanza Ulloa-Márquez

Phone

+34 91 779 28 27

esperanza.ulloa@salud.madrid.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José C. Marín-Gabriel, Assoc. Prof.

Organizational Affiliation

Hospital Universitario 12 de Octubre

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Universitario "12 de Octubre"

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José C. Marín-Gabriel, Assoc. Prof.

Phone

+34 91 779 28 27

josecarlos.marin@salud.madrid.org

First Name & Middle Initial & Last Name & Degree

José C. Marín-Gabriel

First Name & Middle Initial & Last Name & Degree

Esperanza Ulloa-Márquez

First Name & Middle Initial & Last Name & Degree

Alberto Herreros de Tejada

First Name & Middle Initial & Last Name & Degree

Eduardo Albéniz-Arbizu

First Name & Middle Initial & Last Name & Degree

Álvaro Terán-Lantarón

First Name & Middle Initial & Last Name & Degree

Pedro J. Rosón-Rodríguez

First Name & Middle Initial & Last Name & Degree

Joaquín Rodríguez-Sánchez

First Name & Middle Initial & Last Name & Degree

Hugo Uchima-Koecklin

First Name & Middle Initial & Last Name & Degree

Gloria Fernández-Esparrach

First Name & Middle Initial & Last Name & Degree

Adolfo Parra-Blanco

First Name & Middle Initial & Last Name & Degree

David Martínez-Ares

12. IPD Sharing Statement

Plan to Share IPD

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

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