Colo-rectal Cancer Clinical Trial
— AE-RegistryOfficial title:
Advanced Endo-therapeutic Procedure : Registry-based Observational Study at the Centre Hospitalier de l'Université de Montréal (CHUM)
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire de Montréal | Montréal | Quebec |
Canada | Centre Hospitalier Universitaire de Montréal (CHUM) | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
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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