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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06073561
Other study ID # UIC/1593
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date July 31, 2024

Study information

Verified date April 2024
Source Instituto Portugues Oncologia de Lisboa Francisco Gentil
Contact Luís Correia Gomes, MD
Phone +351914534888
Email luisfilipe.gomes@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The global aim of this multi-centric study is to assess the learning curve of U-EMR by an endoscopist skilled in C-EMR aiming to assess the application in real world and check the rate of complete EMR and adverse events related to the procedure.


Description:

Conventional Endoscopic mucosal resection (C-EMR) is currently the standard therapy for the removal of large colon polyps. The procedure consists on the injection of fluids into the submucosa layer below the lesion with the intention to create a cushion to separate it from the muscular layer and avoid its damage and consequently perforation and thermal injury. There are some drawbacks about this technique such us fibrotic polyps, difficult location (areas behind the fold and appendicular orifice) and recurrence rate which without ablation techniques could reach 30%. Underwater endoscopic mucosal resection (U-EMR) has been first described in 2012 by Binmoeller et al [10] and the main difference to C-EMR was the absence of need the submucosal injection. This would be possible because when the lumen is filled with water, the mucosal and the submucosal layer tend to float while the muscularis propria maintains its circular shape even in the presence of peristalsis. Recent data as shown not only a lower rate of recurrence but also a lower procedure time and R0 resections with no difference in adverse events. Therefore, the global aim of this multi-centric study is to assess the learning curve of U-EMR by an endoscopist skilled in C-EMR aiming to assess the application in real world and check the rate of complete EMR and adverse events related to the procedure.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age: 18 years-old or older with at least one large (>10 and <30 mm) non pedunculated polyp - Agreement with study's procedures, having signed the informed consent for the study and EMR, prior to the procedure Exclusion Criteria: - Previous attempted resection - Lesion located at ileo-cecal valve or appendiceal orifice - Fully circumferential lesion - Pedunculated polyps (Paris classification type Ip) and ulcerated depression lesions (Paris classification type III) - Surface pattern suggestive of deep invasion (ex: narrow-band imaging (NBI) International Colorectal Endoscopic (NICE) classification type 3 criteria, Kudo V or equivalent) - Invasive cancer at EMR specimen - Inflammatory bowel disease - Familial polyposis syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Other:
learning curve of Underwater mucosectomy
Patients will be submitted to underwater mucosectomy (U-EMR)

Locations

Country Name City State
Portugal Instituto Português de Oncologia de Lisboa Francisco Gentil Lisboa

Sponsors (1)

Lead Sponsor Collaborator
Instituto Portugues Oncologia de Lisboa Francisco Gentil

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary learning curve of the application of U-EMR by endoscopists skilled in C-EMR evaluate the learning curve of the application of U-EMR by endoscopists skilled in C-EMR after an online course about U-EMR technique. 6 months
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