Recruiting

Observational Study

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04117100

Conditions

Zenker Diverticulum

Polyp of Colon

Colo-rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Polypectomy or myotomy

Study Details

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).

Conditions

Zenker Diverticulum

Polyp of Colon

Colo-rectal Cancer

Study ID

NCT04117100

Start date

Jun 13, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

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).

Primary outcome measure

  • Assess the incidence of overall severe complications following the procedure [ Time Frame: 14 days ]
  • Assess the rate of completeness of neoplastic tissue resection [ Time Frame: 6-18 months ]
  • Severe bleeding complications [ Time Frame: 14 days ]
  • Assess the presence of perforation at resection site [ Time Frame: 6-18 months ]
  • Assess the number of patients with post-polypectomy syndrome [ Time Frame: 6-18 months ]
  • Assess the efficacy of submucosal injectate [ Time Frame: 6-18 months ]
  • Assess the number of patients with intraprocedural bleeding [ Time Frame: 6-18 months ]
  • Assess the number of patients with the need for surgical resection [ Time Frame: 6-18 months ]
  • Technical skill of the endoscopist [ Time Frame: 6-18 months ]
  • En-bloc resection rate [ Time Frame: 6-18 months ]
  • R0 resection rate [ Time Frame: 6-18 months ]
  • Local recurrence rate [ Time Frame: 6-18 months ]
  • Distant metastasis rate [ Time Frame: 6-18 months ]
  • Lymph node involvement rate [ Time Frame: 6-18 months ]
  • Disease progression [ Time Frame: 6-18 months ]
  • Progression-free survival (PFS) [ Time Frame: 6-18 months ]
  • Cancer-related mortality [ Time Frame: 6-18 months ]
  • All-cause mortality [ Time Frame: 6-18 months ]
  • Time to recurrence [ Time Frame: 6-18 months ]
  • Quality of life (QoL) score [ Time Frame: 6-18 months ]

Central Contacts and Locations

Central contacts

Daniel von Renteln, MD, PhD

514-890-8000daniel.von.renteln.med@ssss.gouv.qc.ca

Samira Hanin

514-890-8000samira.hanin.chum@ssss.gouv.qc.ca

Locations

Centre Hospitalier Universitaire de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada

Contacts

Daniel von Renteln, MD, PhD

514-890-8000daniel.von.renteln.med@ssss.gouv.qc.ca

Samira Hanin

514-890-8000samira.hanin.chum@ssss.gouv.qc.ca

Principal Investigator:

Daniel von Renteln, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 11, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-08-11.