Underwater Endoscopic Mucosal Resection

Trial Title: Underwater Endoscopic Mucosal Resection

NCT ID: NCT06073561

Condition: Colon Polyp
Adenoma Colon

Conditions: Official terms:
Adenoma

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Every patient will be selected do underwater emr group.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: learning curve of Underwater mucosectomy
Description: Patients will be submitted to underwater mucosectomy (U-EMR)
Arm group label: Underwater mucosectomy

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Instituto Português de Oncologia de Lisboa Francisco Gentil

Address:
City: Lisboa
Zip: 1099-023
Country: Portugal

Status: Recruiting

Contact:
Last name: Luis Correia Gomes, MD

Start date: January 1, 2024

Completion date: July 31, 2024

Lead sponsor:
Agency: Instituto Portugues Oncologia de Lisboa Francisco Gentil
Agency class: Other

Source: Instituto Portugues Oncologia de Lisboa Francisco Gentil

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06073561