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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04117100
Other study ID # 17.319
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Daniel von Renteln, MD, PhD
Phone 514-890-8000
Email daniel.von.renteln.med@ssss.gouv.qc.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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 Centre Hospitalier de l'Université de Montréal and may identify practices of low quality (possible intervention) or high quality (desired). 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Canada Centre Hospitalier Universitaire de Montréal Montréal Quebec
Canada Centre Hospitalier Universitaire de Montréal (CHUM) Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 14 days
Primary 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. 6-18 months
Primary Assess the local recurrence of polyps Assessment of the presence of biopsy proven neoplastic tissue at the EMR/ESD resection site for hospitalization, transfusion, a repeat endoscopy, surgery, or interventional radiology 6-18 months
Primary Assess the presence of perforation at resection site Assessment of the presence of a complete hole, or full-thickness resection of the muscularis propria 6-18 months
Primary Assess of the number of patients with severe bleeding complications (immediate or delayed) Assessment of severe bleeding as defined as need for hospitalization, tranfusion, a repeat endoscopy, surgery, or interventional radiology. 6-18 months
Primary Assess the number of patients with post-polypectomy syndrome As defined as abdominal pain severe enough to warrant an ER visit or hospital admission and presence of leukocytosis and/or required treatment with antibiotics. 6-18 months
Primary Assess the efficacy of submucosal injectate Assessment of the solution volume per lesion size (ml/cm2), time of resection. 6-18 months
Primary Assess the number of patients with the need for surgical resection Assessment of patients that require surgery for removal of precancerous or cancerous lesions or as result of complications related to the EMR/ESD or endoscopy intervention or for follow-up procedures. 6-18 months
Primary Assess the number of patients with intraprocedural bleeding Assessment of immediate bleeding that requires endoscopic intervention to stop the bleeding (e.g. clip placement or snare tip soft coagulation or coagulation grasper). 6-18 months
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