Clinical trial NCT04117100: Advanced Endo-therapeutic Procedure : Registry-based Observational Study
Official title: Advanced Endo-therapeutic Procedure : Registry-based Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Zenker Diverticulum
Polyp of Colon
Colo-rectal Cancer
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible participants presenting at the CHUM for an elective advanced therapeutic endoscopy (ESD, EMR, advanced polypectomy, POEM or Zenker treatment) will be approached for this research project.

Brief 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).

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.

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

Primary outcomes:
measure: Assess the incidence of overall severe complications following the procedure
timeFrame: 14 days
measure: Assess the rate of completeness of neoplastic tissue resection
timeFrame: 6-18 months
measure: Severe bleeding complications
timeFrame: 14 days
measure: Assess the presence of perforation at resection site
timeFrame: 6-18 months
measure: Assess the number of patients with post-polypectomy syndrome
timeFrame: 6-18 months
measure: Assess the efficacy of submucosal injectate
timeFrame: 6-18 months
measure: Assess the number of patients with intraprocedural bleeding
timeFrame: 6-18 months
measure: Assess the number of patients with the need for surgical resection
timeFrame: 6-18 months
measure: Technical skill of the endoscopist
timeFrame: 6-18 months
measure: En-bloc resection rate
timeFrame: 6-18 months
measure: R0 resection rate
timeFrame: 6-18 months
measure: Local recurrence rate
timeFrame: 6-18 months
measure: Distant metastasis rate
timeFrame: 6-18 months
measure: Lymph node involvement rate
timeFrame: 6-18 months
measure: Disease progression
timeFrame: 6-18 months
measure: Progression-free survival (PFS)
timeFrame: 6-18 months
measure: Cancer-related mortality
timeFrame: 6-18 months
measure: All-cause mortality
timeFrame: 6-18 months
measure: Time to recurrence
timeFrame: 6-18 months
measure: Quality of life (QoL) score
timeFrame: 6-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre Hospitalier Universitaire de Montréal (CHUM)
name: Daniel von Renteln, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: