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Advanced Endo-therapeutic Procedure : Registry-based Observational Study

ConditionsZenker DiverticulumPolyp of ColonColo-rectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

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

Signed informed consent form

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Polypectomy or myotomy

    Procedure/Surgery

    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, Assessment of polypectomy quality for colorectal adenomas/polyps, Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC), and Per Oral endoscopic Myotomy (POEM).

Treatment groups

500 Participants
are divided into 4 treatment groups
Group A: Endoscopic mucosal resection (EMR)1 intervention
Group B: Endoscopic mucosal dissection (ESD)1 intervention
Group C: Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC)1 intervention
Group D: Per Oral Endoscopic Myotomy (POEM)1 intervention

Trial outcomes

Primary outcomes

1

Assess the incidence of overall severe complications following the procedure

Aggregate of all severe adverse events that occur at the time of the procedure (immediate complications) or during 14 days of follow-up. Severe adverse events include bleeding, perforation, and clinical events that require an admission to the hospital.

Time frame
14 days
2

Assess the rate of completeness of neoplastic tissue resection

Assessment of the complete adenoma/Barretts/dysplastic tissue removal, defined as removal of all visible neoplastic tissue at the end of the EMR as assessed by the endoscopist.

Time frame
6-18 months
3

Severe bleeding complications

Immediate or delayed: severe bleeding is defined as the need for hospitalization, transfusion, a repeat endoscopy, surgery, or interventional radiology. An immediate complication is defined as an event at the time of resection or immediately following the endoscopy (before patient has left the endoscopy unit/during immediate post-colonoscopy care). A delayed complication is defined as a bleeding event that occurred after the patient has left the endoscopy unit and within 14 days following the procedure.

Time frame
14 days
4

Assess the presence of perforation at resection site

Assessment of the presence of a complete hole, or full-thickness resection of the muscularis propria

Time frame
6-18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Source ClinicalTrials.gov
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