Advanced Endo-therapeutic Procedure : Registry-based Observational Study

Colo-rectal Cancer Clinical Trial

— AE-Registry  

Official title:

Advanced Endo-therapeutic Procedure : Registry-based Observational Study at the Centre Hospitalier de l'Université de Montréal (CHUM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117100
• Other study ID #: 17.319
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colonic Polyps
• Diverticulum
• Polyp of Colon
• Zenker Diverticulum

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