An observational study in Zenker Diverticulum, Polyp of Colon and Colo-rectal Cancer, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational
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).
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 500 is above the median of 411 across 115 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All eligible participants presenting at the CHUM for an elective advanced therapeutic endoscopy (ESD, EMR, advanced polypectomy, POEM or Zenker treatment) will be approached for this research project.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
It has become the standard treatment for superficial tumors of the gastrointestinal tract, either flat or sessile: precancerous lesions and superficial cancers with no or low ganglionic risk. The pre-injection of physiological serum detaches the lesion from the deep plane and allows, with great security, the resection of the mucosa, muscularis mucosae with part of the submucosa, whatever the size and location of the lesion. Compared to other techniques, it allows a histological analysis which dictates the subsequent conduct and the possible need for a complementary surgery.
Procedure: Polypectomy or myotomy
This technique uses submucosal injection and special knives to make a peri-lesional circumferential incision, followed by dissection through the submucosal sub-lesion.
Procedure: Polypectomy or myotomy
This is a mucosal thermo-destruction technique. It uses a generator that delivers a sinusoidal current of high frequency to a probe covered with bipolar electrodes in tight network ensuring a uniform diffusion of the thermal effect. The tissue penetration is superficial on 1mm, intended to eradicate the epithelium up to the muscularis mucosae. Circumferential or focal probes are used as a function of the length of the segment to be treated.
Procedure: Polypectomy or myotomy
This technique allows a myotomy on the 8 cm of the lower esophagus extended on the gastric side of the cardia, totally endoscopically, after having approached and tunneled the esophageal submucosa. Less invasive, it gradually replaces the pneumatic dilatation and surgical myotomy of Heller. It requires a general anesthesia, an expert operator and a trained nursing team, ESD instruments, carbone dioxide insufflation.
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).
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.
Time frame: 14 days
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.
Time frame: 6-18 months
Severe bleeding complications
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: 14 days
Assess the presence of perforation at resection site
Assessment of the presence of a complete hole, or full-thickness resection of the muscularis propria
Time frame: 6-18 months
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.
Time frame: 6-18 months
Assess the efficacy of submucosal injectate
Assessment of the solution volume per lesion size (ml/cm2), time of resection.
Time frame: 6-18 months
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).
Time frame: 6-18 months
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.
Time frame: 6-18 months
Technical skill of the endoscopist
Video based assessment of endoscopic resection skills
Time frame: 6-18 months
En-bloc resection rate
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
R0 resection rate
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
Local recurrence rate
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
Distant metastasis rate
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
Lymph node involvement rate
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
Disease progression
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
Progression-free survival (PFS)
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
Cancer-related mortality
Death directly attributable to the primary cancer or its complications, as determined by clinical assessment, autopsy, or death records.
Time frame: 6-18 months
All-cause mortality
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
Time to recurrence
The interval between the date of initial curative treatment and the detection of local recurrence or distant metastasis.
Time frame: 6-18 months
Quality of life (QoL) score
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.
Time frame: 6-18 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2018 to primary completion in Dec 2025, 90 months.
Of 52 non-industry observational studies under Colonic Polyps, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 90. This study's 90 months is above that.
Counting every sponsor, half of 62 studies reached it within 19 months; a quarter within 10 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
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