Advanced Endo-therapeutic Procedure : Registry-based Observational Study

Last updated: February 28, 2025
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Polyps

Polyps

Treatment

Polypectomy or myotomy

Clinical Study ID

NCT04117100
2018-7692/17.319
  • Ages > 18
  • All Genders

Study Summary

Advanced therapeutic endoscopy procedures are of increasing importance to provide minimal invasive treatment for GI diseases. The Centre Hospitalier de l'Université de Montréal as tertiary university center is dedicated to increase the availability of therapeutic endoscopy procedures for our population in Montreal and Quebec. Advanced endotherapeutic endoscopy can replace surgery for treatment of benign and malign GI diseases and the aim of this registry-based study is to improve quality related to advanced endotherapeutic endoscopy, as it will provide quantitative means to assess advanced endotherapeutic practice and may identify practices of low quality (possible intervention) or high quality (desired).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years

  • Presenting for an elective advanced therapeutic endoscopy (ESD, EMR, advancedpolypectomy, POEM or Zenker treatment)

  • Signed informed consent form

Exclusion

Exclusion Criteria:

  • Patients that are not capable understanding the trial and patients without consent.

  • Patients with coagulopathy

  • Patient with poor general health defined as an American Society of Anesthesiologistsclass greater than three

  • Pregnancy

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Polypectomy or myotomy
Phase:
Study Start date:
June 01, 2018
Estimated Completion Date:
December 31, 2025

Study Description

Advanced therapeutic endoscopy procedures included for this registry-based study are endoscopic mucosal resection (EMR), Endoscopic mucosal dissection (ESD), Assessment of Polypectomy quality for colorectal adenomas/polyps, Radio frequency Ablation (RFA) and Argon Plasma Ablation (APC), and Per Oral endoscopic Myotomy (POEM). All patients who present for an advanced endotherapeutic endoscopy (ESD, EMR, deep resection, POEM or Zenker treatment) may be included into the registry. Data will be collected prospectively. Data will be recorded on case report forms (CRF), which will then be transferred to an electronic data base (= registry), located on a protected drive.

Connect with a study center

  • Centre Hospitalier Universitaire de Montréal

    Montréal, Quebec
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire de Montréal (CHUM)

    Montréal, Quebec
    Canada

    Active - Recruiting

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