Underwater Endoscopic Mucosal Resection

NCT06073561 | Recruiting

• 1 other identifier: UIC/1593
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Polyp; Adenoma Colon

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Underwater mucosectomy

EXPERIMENTAL

Every colonoscopy should be performed with a high definition colonoscope, such as Olympus series Q185 or Q190 with virtual chromoendoscopy by NBI (Olympus Inc., Tokyo, Japan) or Fujifilm EC-760R-V/L or EC-760Z-V/L with virtual chromoendoscopy by LBI (Fujifilm Group, Japan). A study investigator or a senior endoscopy fellow under their direct supervision should perform all procedures. The U-EMR procedure should include the following steps: CO2 should be completely removed, and the bowel lumen filled with normal saline using a water jet pump (OFP-2, Olympus Medical System or similar) until the lesion is totally immersed in water. The lesion and 2-3 mm of normal surrounding mucosa should be resected using electrocauterization (VIO 200D Endocut Q Effect 3; ERBE Electromedizin, Tübingen, Germany).

Other: learning curve of Underwater mucosectomy

Interventions

learning curve of Underwater mucosectomy OTHER

Patients will be submitted to underwater mucosectomy (U-EMR)

Underwater mucosectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Portugues Oncologia de Lisboa Francisco Gentil: lead

Study Sites (1)

Instituto Português de Oncologia de Lisboa Francisco Gentil

Lisbon, 1099-023, Portugal

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luís Correia Gomes, MD

CONTACT

+351914534888; luisfilipe.gomes@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Degree

Model Details: Every patient will be selected do underwater emr group.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)