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Underwater Endoscopic Mucosal Resection

Primary Purpose

Colon Polyp, Adenoma Colon

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
learning curve of Underwater mucosectomy
Sponsored by
Instituto Portugues Oncologia de Lisboa Francisco Gentil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Polyp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Underwater mucosectomy

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 20, 2023
    Sponsor
    Instituto Portugues Oncologia de Lisboa Francisco Gentil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06073561
    Brief Title
    Underwater Endoscopic Mucosal Resection
    Official Title
    Underwater Endoscopic Mucosal Resection a Learning Curve Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    February 27, 2024 (Anticipated)
    Study Completion Date
    March 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Portugues Oncologia de Lisboa Francisco Gentil

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Polyp, Adenoma Colon

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Every patient will be selected do underwater emr group.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Underwater mucosectomy
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    learning curve of Underwater mucosectomy
    Intervention Description
    Patients will be submitted to underwater mucosectomy (U-EMR)
    Primary Outcome Measure Information:
    Title
    learning curve of the application of U-EMR by endoscopists skilled in C-EMR
    Description
    evaluate the learning curve of the application of U-EMR by endoscopists skilled in C-EMR after an online course about U-EMR technique.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luís Correia Gomes, MD
    Phone
    +351914534888
    Email
    luisfilipe.gomes@outlook.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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