Underwater Endoscopic Mucosal Resection

Underwater Endoscopic Mucosal Resection a Learning Curve Study

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.

Study Overview

• Status: Recruiting
• Conditions: Colon Polyp; Adenoma Colon
• Intervention / Treatment: Other: learning curve of Underwater mucosectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luís Correia Gomes, MD; Phone Number: +351914534888; Email: luisfilipe.gomes@outlook.com

Study Locations

• Portugal
  • Lisboa, Portugal, 1099-023
    • Recruiting
    • Instituto Português de Oncologia de Lisboa Francisco Gentil
    • Contact: Luis Correia Gomes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Underwater mucosectomy; 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; Patients will be submitted to underwater mucosectomy (U-EMR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto Portugues Oncologia de Lisboa Francisco Gentil

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: UIC/1593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No