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Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions

Primary Purpose

Adenoma Colon, Serrated Polyp, Serrated Adenoma

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Standard Endoscopic Mucosal Resection

Cold Snare Endoscopic Mucosal Resection

About this trial

This is an interventional treatment trial for Adenoma Colon focused on measuring endoscopic mucosal resection, cold snare endoscopic mucosal resection, standard endoscopic mucosal resection, large nonpedunculated homogeneous colorectal lesions, adenoma colon, serrated polyp, serrated adenoma, conventional endoscopic mucosal resection, laterally spreading adenomas.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients of age > 18 years undergoing a colonoscopy for any reason of request and who do not meet exclusion criteria.
Nonpedunculated homogeneous colorectal lesions type LST ( Paris 0-IIa morphology) and serrated lesions larger than 20 mm without endoscopic data of malignancy: NICE 1 pattern +/- NICE 2 component ( serrated lesions) or NICE2 pattern/JNET 2A (adenomas) and therefore subsidiaries of RME. Randomization will be performed per patient, not for colorectal lesions
Signature of informed consent of endoscopic exploration

Exclusion Criteria:

.No signature of informed consent prior to the study procedure.
Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations (BSG and ESGE guidelines)
Patients with severe thrombopenia/ coagulopathy (Platelets < 50,000/INR > 1.5) not corrected prior to procedure (plasma or platelet transfusion)
Patients not candidates for endoscopic resection of colorectal lesions by comorbidities.
Pregnant.
Patients with inflammatory bowel disease (IBD)
Urgent colonoscopy.
Poor preparation (BBPS <2 in the colon segment where the lesion is located)
Laterally spreading tumors (LST) lesions with non-homogeneous morphology including: sessile polyps (0-Is), pedunculated (0-Ip) and LST lesions with depressed or excavated components (Paris 0-IIc or Paris 0-III), LST granular nodular mixed, LST-G with whole nodular type. In case of doubt depressed component (Paris 0-IIc) or histological borderline lesion (JNET2B), will be excluded from the study.
Histological prediction of deep invasive or non-subsidiary to endoscopic mucosal resection lesion as a treatment of choice: NICE 3 pattern by inspection with NBI or Kudo V pattern in traditional/electronic chromoendoscopy or Sano IIIA/IIIB pattern
Endoscopic resection of post-EMR scar level relapses

Sites / Locations

Óscar Nogales Rincón

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Standard Endoscopic Mucosal Resection

Cold Snare Endoscopic Mucosal Resection

Arm Description

Standard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm)

Cold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm)

Outcomes

Primary Outcome Measures

Complete resection of the lesion

Complete resection of the lesion is defined as the non-visualization by the endoscopist of a residual lesion in the mucosal defect and its edge at the end of the EMR and no visualization of recurrence in the post-EMR scar on the first surveillance colonoscopy and absence of recurrence data in scar biopsies

Secondary Outcome Measures

Security profile

Security profile is defined as the observed percentage of complications (Intra-procedure bleeding, deferred bleeding, deferred bleeding in antiplatelet and/or anticoagulated patients,post-polypectomy fever, post-polypectomy syndrome, deep muscle damage and perforation) in each of the evaluated techniques.

Late adenoma recurrence rate

Late adenoma recurrence rate as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies) in surveillance colonoscopy at 18 months of the procedure

Number of fragments needed to complete the resection

Number of fragments needed to resect with polypectomy snare to complete the resection of the colorectal lesion.

Resection time

Time needed to perform endoscopic mucosal resection measured from first snare positioning until complete resection is achieved based on endoscopic assessment.

Bloc resection rate

Number of lesions that have undergone resection in a single fragment with each of these evaluated techniques.

R0 resection rate

Number of lesions with complete macroscopic resection with a negative microscopic margin in the mucosectomy specimen

EMR technique conversion rate

Number of lesions to be finally resected with the other arm of study technique not initially assigned

Need for additional treatments to complete the resection.

Number of lesions that cannot be completely resected with the assigned EMR technique, requiring different techniques to complete the resection, such as SOFT coagulation with snare tip, APC (argon plasma coagulation), hot avulsion with hot biopsy forceps, biopsy forceps, biopsy forceps +ablation

Number of clips used

Number of clip used for hemostatic purposes or for the prophylactic closure of the injury

Degree of artifact/interference in the histological interpretation

Subjective impression of the artifact in the histological interpretation of the resected sample (null, moderate, severe)

Depth of the resected submucosa

Measure the depth of the resected submucosa layer (in microns) with each of the resection techniques used

Percentage of mucosal muscle present in the mucosal protrusions in the resection defect of cold-EMR.

Assess the percentage of presence of mucosal muscle in biopsies performed on the protrusions present in the resection defect of cold-EMR

Need for surgery for technical failure

Number of lesions that have to be finally resected by surgery due to technical impossibility for their endoscopic resection.

Cost-effectiveness study.

evaluate the cost-effectiveness of each of the endoscopic mucosal resection techniques

Sub-analysis by center participating in the study

A subanalysis of the study results by center will be carried out to rule out significant differences between them

Full Information

NCT ID

NCT04418843

First Posted

June 3, 2020

Last Updated

September 25, 2023

Sponsor

Oscar Nogales

Collaborators

Spanish Society of Digestive Endoscopy

1. Study Identification

Unique Protocol Identification Number

NCT04418843

Brief Title

Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions

Official Title

Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions.Randomized and Multicentric Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

June 8, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Oscar Nogales

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

Yes

5. Study Description

Brief Summary

This study compares the effectiveness in complete resection (absence of recurrence at 6 months) the two different techniques for performing endoscopic mucosal resection (EMR) of nonpedunculated homogeneous colorectal lesions >20mm

Detailed Description

Colonoscopy is the reference diagnostic test for the study of colon diseases. This procedure also allows the realization of endoscopic therapeutics techniques; thus, endoscopic mucosal resection (EMR) is an effective and safe therapy for the treatment of premalignant and early malignant colorectal lesions of the colon and its use is universal. Usually, colon lesions larger than 10 mm (or pedunculated of any size) require for resection the use of electrocoagulation current (or hot snare polypectomy) and thus is reflected in the most recent clinical practice guidelines (ESGE guidelines, for example). However, the risk of side adverse effects from the use of electrocoagulation is not insignificant and includes post-polypectomy bleeding, post-polypectomy syndrome, post-polypectomy fever and/or immediate or delayed perforation. This risk of complications is higher depending on the characteristics and size of colorectal lesions resected. On the other hand, currently in small lesions not pedunculated (< 10 mm), it is recommended to use cold snare polypectomy according to ESGE clinical guidelines, as it has been seen in previous studies that this reduces complication rates without varying the effectiveness in resection. However, in lesions > 10 mm the previous experience with cold snare resection is less, probably motivated by the possible drawbacks in terms of the possible difficulty of resection of thick tissue with cold snare and a possible increased intra-procedure hemorrhagic risk that can make it difficult to see the scar, with the possibility of leaving residual tissue. However, in recent years the accumulated evidence gathered in various studies and grouped in a recent systematic review suggests that endoscopic mucosal resection with cold snare (Cold-EMR) may be safer than electrocoagulation resection for both 10-19mm lesions and for lesions >20 mm, associated with a lower rate of adverse effects with similar efficacy rates in terms of complete resection and adenomatous recurrence rate. Still, evidence for the treatment of nonpedunculated lesions >20 mm is relatively limited and is not based on randomized comparative studies with the standard EMR technique.

6. Conditions and Keywords

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

Adenoma Colon, Serrated Polyp, Serrated Adenoma, Colorectal Neoplasms

Keywords

endoscopic mucosal resection, cold snare endoscopic mucosal resection, standard endoscopic mucosal resection, large nonpedunculated homogeneous colorectal lesions, adenoma colon, serrated polyp, serrated adenoma, conventional endoscopic mucosal resection, laterally spreading adenomas.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective randomized study (1:1), multicenter, non-blind of consecutive non-pedunculated lesions of serrated and adenomatous histology, homogeneous, with a size greater than or equal to 20 mm (no upper limit in size). Performing cold-EMR vs standard EMR. A non-inferiority study of cold-EMR versus standard EMR.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

229 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Endoscopic Mucosal Resection

Arm Type

Experimental

Arm Description

Standard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm)

Arm Title

Cold Snare Endoscopic Mucosal Resection

Arm Type

Experimental

Arm Description

Cold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm)

Intervention Type

Procedure

Intervention Name(s)

Standard Endoscopic Mucosal Resection

Other Intervention Name(s)

Standard EMR

Intervention Description

Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery

Intervention Type

Procedure

Intervention Name(s)

Cold Snare Endoscopic Mucosal Resection

Other Intervention Name(s)

Cold EMR

Intervention Description

Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery

Primary Outcome Measure Information:

Title

Complete resection of the lesion

Description

Time Frame

3-6 months

Secondary Outcome Measure Information:

Title

Security profile

Description

Time Frame

30 days

Title

Late adenoma recurrence rate

Description

Time Frame

18 months

Title

Number of fragments needed to complete the resection

Description

Number of fragments needed to resect with polypectomy snare to complete the resection of the colorectal lesion.

Time Frame

1 day

Title

Resection time

Description

Time needed to perform endoscopic mucosal resection measured from first snare positioning until complete resection is achieved based on endoscopic assessment.

Time Frame

1 day

Title

Bloc resection rate

Description

Number of lesions that have undergone resection in a single fragment with each of these evaluated techniques.

Time Frame

Title

R0 resection rate

Description

Number of lesions with complete macroscopic resection with a negative microscopic margin in the mucosectomy specimen

Time Frame

1 day

Title

EMR technique conversion rate

Description

Number of lesions to be finally resected with the other arm of study technique not initially assigned

Time Frame

1 day

Title

Need for additional treatments to complete the resection.

Description

Time Frame

1 day

Title

Number of clips used

Description

Number of clip used for hemostatic purposes or for the prophylactic closure of the injury

Time Frame

1 day

Title

Degree of artifact/interference in the histological interpretation

Description

Subjective impression of the artifact in the histological interpretation of the resected sample (null, moderate, severe)

Time Frame

1 day

Title

Depth of the resected submucosa

Description

Measure the depth of the resected submucosa layer (in microns) with each of the resection techniques used

Time Frame

1 day

Title

Percentage of mucosal muscle present in the mucosal protrusions in the resection defect of cold-EMR.

Description

Assess the percentage of presence of mucosal muscle in biopsies performed on the protrusions present in the resection defect of cold-EMR

Time Frame

1 day

Title

Need for surgery for technical failure

Description

Number of lesions that have to be finally resected by surgery due to technical impossibility for their endoscopic resection.

Time Frame

6 months

Title

Cost-effectiveness study.

Description

evaluate the cost-effectiveness of each of the endoscopic mucosal resection techniques

Time Frame

18 months

Title

Sub-analysis by center participating in the study

Description

A subanalysis of the study results by center will be carried out to rule out significant differences between them

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of age > 18 years undergoing a colonoscopy for any reason of request and who do not meet exclusion criteria. Nonpedunculated homogeneous colorectal lesions type LST ( Paris 0-IIa morphology) and serrated lesions larger than 20 mm without endoscopic data of malignancy: NICE 1 pattern +/- NICE 2 component ( serrated lesions) or NICE2 pattern/JNET 2A (adenomas) and therefore subsidiaries of RME. Randomization will be performed per patient, not for colorectal lesions Signature of informed consent of endoscopic exploration Exclusion Criteria: .No signature of informed consent prior to the study procedure. Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations (BSG and ESGE guidelines) Patients with severe thrombopenia/ coagulopathy (Platelets < 50,000/INR > 1.5) not corrected prior to procedure (plasma or platelet transfusion) Patients not candidates for endoscopic resection of colorectal lesions by comorbidities. Pregnant. Patients with inflammatory bowel disease (IBD) Urgent colonoscopy. Poor preparation (BBPS <2 in the colon segment where the lesion is located) Laterally spreading tumors (LST) lesions with non-homogeneous morphology including: sessile polyps (0-Is), pedunculated (0-Ip) and LST lesions with depressed or excavated components (Paris 0-IIc or Paris 0-III), LST granular nodular mixed, LST-G with whole nodular type. In case of doubt depressed component (Paris 0-IIc) or histological borderline lesion (JNET2B), will be excluded from the study. Histological prediction of deep invasive or non-subsidiary to endoscopic mucosal resection lesion as a treatment of choice: NICE 3 pattern by inspection with NBI or Kudo V pattern in traditional/electronic chromoendoscopy or Sano IIIA/IIIB pattern Endoscopic resection of post-EMR scar level relapses

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oscar Nogales

Organizational Affiliation

Hospital General Universitario Gregorio Marañon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Óscar Nogales Rincón

City

Madrid

ZIP/Postal Code

28007

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions

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