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Hot EMR vs Underwater Cold EMR for Large Colonic Adenomas

NCT06217250 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2024-04-18

No results posted yet for this study

Summary

This randomized, multi-center trial aims to evaluate the advantages of underwater cold endoscopic mucosal resection technique (CS-EMR) in comparison to the conventional endoscopic mucosal resection technique (EMR) for laterally spreading colorectal lesions exceeding 20 mm in size. More precisely, our hypothesis posits that underwater cold EMR is non-inferior to conventional EMR in terms of recurrence rates, resection completeness and safety.

Conditions

  • Colonic Neoplasms
  • Colonic Adenoma
  • Colonic Lesion

Interventions

PROCEDURE

Traditional EMR

Conventional EMR with thermal ablation of resection margins: initial submucosal injection of saline and methylene blue and subsequent piecemeal resection with 10- or 15-mm diathermic snare with subsequent thermal ablation of resection margins with snare tip soft coagulation.Nevertheless, this technique is associated with the emergence of serious adverse events (SAEs), including delayed bleeding (PPB), electrocautery-induced post-polipectomy syndrome (PPS), and perforation(4).

PROCEDURE

the cold snare ("CO"), underwater technique ("W"), and the use of submucosal lift ("L") in both study arms

The "cold-EMR" technique, as opposed to the conventional approach, employs a specialized snare that enables tissue transection without the need for electrical current, particularly in appropriately selected lesions. This approach yields the same efficacy outcome as the conventional procedure but offers the advantage of reducing the risks associated with polypectomy, which are often secondary to the use of diathermic current. Subsequently, the lesion fragments are retrieved for histological examination. Furthermore, the use of underwater setting, as demonstrated for hot EMR, could improve the effectiveness of cold-EMR.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2025-12-31
Completion
2026-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06217250 on ClinicalTrials.gov