Colo-rectal Cancer, Polyp of Colon, Zenker Diverticulum
Conditions
Brief 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. 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).
Detailed description
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.
Interventions
PROCEDUREPolypectomy 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).
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the incidence of overall severe complications following the procedure | 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. |
| Assess the rate of completeness of neoplastic tissue resection | 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. |
| Severe bleeding complications | 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. |
| Assess the presence of perforation at resection site | 6-18 months | Assessment of the presence of a complete hole, or full-thickness resection of the muscularis propria |
| Assess the number of patients with post-polypectomy syndrome | 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. |
| Assess the efficacy of submucosal injectate | 6-18 months | Assessment of the solution volume per lesion size (ml/cm2), time of resection. |
| Assess the number of patients with intraprocedural bleeding | 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). |
| Assess the number of patients with the need for surgical resection | 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. |
| Technical skill of the endoscopist | 6-18 months | Video based assessment of endoscopic resection skills |
| En-bloc resection rate | 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. |
| R0 resection rate | 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. |
| Local recurrence rate | 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. |
| Distant metastasis rate | 6-18 months | The rate of development of cancerous spread to distant organs or sites beyond the original tumor location after initial curative treatment. |
| Lymph node involvement rate | 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. |
| Disease progression | 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. |
| Progression-free survival (PFS) | 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. |
| Cancer-related mortality | 6-18 months | Death directly attributable to the primary cancer or its complications, as determined by clinical assessment, autopsy, or death records. |
| All-cause mortality | 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 to recurrence | 6-18 months | The interval between the date of initial curative treatment and the detection of local recurrence or distant metastasis. |
| Quality of life (QoL) score | 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. |
Countries
Canada
Contacts
CONTACTDaniel von Renteln, MD, PhD
CONTACTSamira Hanin
PRINCIPAL_INVESTIGATORDaniel von Renteln, MD,PhD
Centre Hospitalier Universitaire de Montréal (CHUM)
Outcome results
None listed