Zenker DiverticulumAE RegistryNCT04117100
Advanced Endo-therapeutic Procedure : Registry-based Observational Study
An observational study of Zenker Diverticulum and Polyp of Colon, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zenker Diverticulum, Polyp of Colon, Colo-rectal Cancer
- What is being tested?
- Polypectomy or myotomy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jun 2018to 31 Dec 2026
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age >18 years
- Presenting for an elective advanced therapeutic endoscopy (ESD, EMR, advanced polypectomy, POEM or Zenker treatment)
- Signed informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Montréal (CHUM)
Montreal, Quebec
Daniel von Renteln, MD, PhD, 514-890-8000 ext. 30655, daniel.von.renteln.med@ssss.gouv.qc.ca
Samira Hanin, 514-890-8000 ext. 30916, samira.hanin.chum@ssss.gouv.qc.ca
About this study
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).
Read the 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.
- Conditions
- Zenker Diverticulum, Polyp of Colon, Colo-rectal Cancer
- Being tested
- Polypectomy or myotomy
- Medical subject headings
- Zenker Diverticulum, Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypectomy or myotomyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic mucosal resection (EMR) | 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. Receives: Procedure: Polypectomy or myotomy | |
| Endoscopic mucosal dissection (ESD) | This technique uses submucosal injection and special knives to make a peri-lesional circumferential incision, followed by dissection through the submucosal sub-lesion. Receives: Procedure: Polypectomy or myotomy | |
| Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC) | 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. Receives: Procedure: Polypectomy or myotomy | |
| Per Oral Endoscopic Myotomy (POEM) | 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. Receives: Procedure: Polypectomy or myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6-18 months
Assess the efficacy of submucosal injectate
Assessment of the solution volume per lesion size (ml/cm2), time of resection.
Measured: 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).
Measured: 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.
Measured: 6-18 months
Technical skill of the endoscopist
Video based assessment of endoscopic resection skills
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-18 months
Time to recurrence
The interval between the date of initial curative treatment and the detection of local recurrence or distant metastasis.
Measured: 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.
Measured: 6-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start13 Jun 2018
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zenker DiverticulumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel von Renteln, MD,PhD, Principal investigator, Centre Hospitalier Universitaire de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117100
- Sponsor's protocol ID
- 2018-7692/17.319
- Acronym
- AE Registry
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2019
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Endo-therapeutic Procedure : Registry-based Observational Study
- ClinicalTrials.gov ID
- NCT04117100
- Acronym / sponsor ID
- AE Registry / 2018-7692/17.319
- Conditions
- Zenker Diverticulum, Polyp of Colon, Colo-rectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Endoscopic mucosal resection (EMR) | – | Procedure: Polypectomy or myotomyIt 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. |
| Endoscopic mucosal dissection (ESD) | – | Procedure: Polypectomy or myotomyThis technique uses submucosal injection and special knives to make a peri-lesional circumferential incision, followed by dissection through the submucosal sub-lesion. |
| Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC) | – | Procedure: Polypectomy or myotomyThis 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. |
| Per Oral Endoscopic Myotomy (POEM) | – | Procedure: Polypectomy or myotomyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age >18 years
- Presenting for an elective advanced therapeutic endoscopy (ESD, EMR, advanced polypectomy, POEM or Zenker treatment)
- Signed informed consent form
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypectomy or myotomyAdvanced 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). | Procedure or surgery | Endoscopic mucosal dissection (ESD), Endoscopic mucosal resection (EMR), Per Oral Endoscopic Myotomy (POEM), Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC) |
Primary outcome
Assess the incidence of overall severe complications following the procedure
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.
Assess the rate of completeness of neoplastic tissue resection
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.
Severe bleeding complications
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.
Assess the presence of perforation at resection site
Time frame: 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
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.
Assess the efficacy of submucosal injectate
Time frame: 6-18 months
Assessment of the solution volume per lesion size (ml/cm2), time of resection.
Assess the number of patients with intraprocedural bleeding
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).
Assess the number of patients with the need for surgical resection
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.
Technical skill of the endoscopist
Time frame: 6-18 months
Video based assessment of endoscopic resection skills
En-bloc resection rate
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.
R0 resection rate
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.
Local recurrence rate
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.
Distant metastasis rate
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.
Lymph node involvement rate
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.
Disease progression
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.
Progression-free survival (PFS)
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.
Cancer-related mortality
Time frame: 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
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 to recurrence
Time frame: 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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel von Renteln, MD,PhD principal investigator
Centre Hospitalier Universitaire de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zenker Diverticulum and Polyp of Colon, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel von Renteln, MD, PhD (514-890-8000, daniel.von.renteln.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the incidence of overall severe complications following the procedure (time frame: 14 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.