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Recruiting NCT04117100

Advanced Endo-therapeutic Procedure : Registry-based Observational Study

— Observational Zenker Diverticulum Polyp of Colon Colo-rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polypectomy or myotomy.
Who it may be relevant to
Registry conditions: Zenker Diverticulum, Polyp of Colon, Colo-rectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Detailed 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.

Interventions

  • Procedure Polypectomy or myotomy
    Advanced therapeutic endoscopy can replace surgery for treatment of benign and malign GI diseases and the aim of this registry-based study to improve quality related to advanced therapeutic endoscopy because the trial will provides a quantitative method to assess advanced therapeutic practise at the CHUM and may identify practices of low quality (possible intervention) or high quality (desired). Advanced therapeutic endoscopy procedures included for this registry-based study are EMR, ESD, Assess

Primary outcome measures

  • Assess the incidence of overall severe complications following the procedure [Time frame: 14 days]
  • Assess the rate of completeness of neoplastic tissue resection [Time frame: 6-18 months]
  • Severe bleeding complications [Time frame: 14 days]
  • Assess the presence of perforation at resection site [Time frame: 6-18 months]
  • Assess the number of patients with post-polypectomy syndrome [Time frame: 6-18 months]
  • Assess the efficacy of submucosal injectate [Time frame: 6-18 months]
  • Assess the number of patients with intraprocedural bleeding [Time frame: 6-18 months]
  • Assess the number of patients with the need for surgical resection [Time frame: 6-18 months]
  • Technical skill of the endoscopist [Time frame: 6-18 months]
  • En-bloc resection rate [Time frame: 6-18 months]

Eligibility criteria

Inclusion criteria

  • Age >18 years
  • Presenting for an elective advanced therapeutic endoscopy (ESD, EMR, advanced polypectomy, POEM or Zenker treatment)
  • Signed informed consent form

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 Anesthesiologists class greater than three
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Centre Hospitalier Universitaire de Montréal (CHUM) — Montreal

Identifiers

NCT: NCT04117100 · 2018-7692/17.319

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗