NCT Number: NCT04117100
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Montreal, Quebec, Canada
Location status: Recruiting
Daniel von Renteln, MD
PRINCIPAL_INVESTIGATOR
Daniel von Renteln, MD, PhD
CONTACT
514-890-8000 ext. 30655
Samira Hanin
CONTACT
514-890-8000 ext. 30916
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 14 days
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: 6-18 months
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: 14 days
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: 6-18 months
Assessment of the presence of a complete hole, or full-thickness resection of the muscularis propria
Time frame: 6-18 months
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.
Time frame: 6-18 months
Assessment of the solution volume per lesion size (ml/cm2), time of resection.
Time frame: 6-18 months
Assessment of immediate bleeding that requires endoscopic intervention to stop the bleeding (e.g. clip placement or snare tip soft coagulation or coagulation grasper).
Time frame: 6-18 months
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.
Time frame: 6-18 months
Video based assessment of endoscopic resection skills
Time frame: 6-18 months
The number of cases with complete removal of the targeted lesion in a single piece without fragmentation (ensuring the entire specimen can be assessed for histopathological margins and integrity) out of all the cases.
Time frame: 6-18 months
The number of cases with a resection with histologically confirmed negative margins (indicating no residual tumor cells at the resection site, both lateral and deep margins are free of neoplastic involvement) out of all cases.
Time frame: 6-18 months
The rate of reappearance of biopsy-confirmed neoplastic tissue at the original resection site during surveillance endoscopies or detection of cancer in the same area on imaging after the initial curative treatment.
Time frame: 6-18 months
The rate of development of cancerous spread to distant organs or sites beyond the original tumor location after initial curative treatment.
Time frame: 6-18 months
The rate of detection of cancerous infiltration in regional or distant lymph nodes, identified through imaging, biopsy, or surgical pathology, after initial curative treatment.
Time frame: 6-18 months
Worsening of the disease, as evidenced by local recurrence, distant metastasis, lymph node involvement, or the appearance of new lesions, after the initial curative treatment.
Time frame: 6-18 months
The time from the date of initial treatment to the earliest occurrence of disease progression (local recurrence, distant metastasis, lymph node involvement, or new lesion development) or death from any cause, whichever occurs first.
Time frame: 6-18 months
Death directly attributable to the primary cancer or its complications, as determined by clinical assessment, autopsy, or death records.
Time frame: 6-18 months
Death from any cause, including cancer-related and unrelated causes, during the study period or follow-up after initial curative treatment.
Time frame: 6-18 months
The interval between the date of initial curative treatment and the detection of local recurrence or distant metastasis.
Time frame: 6-18 months
Patient-reported or clinician-assessed outcomes measuring physical, emotional, and social well-being, as well as symptom burden, during or after treatment. The EQ-5D-5L score will be used, which is a health status measurement that ranges from -0.59 to 1, where 1 indicates excellent health status.
Contact information is provided by the study sponsor or research team.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Acronym: AE Registry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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