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Advanced Endo-therapeutic Procedure : Registry-based Observational Study (AE-Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117100
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment
Zenker Diverticulum Polyp of Colon Colo-rectal Cancer Procedure: Polypectomy or myotomy

Detailed Description:
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 Centre Hospitalier de l'Université de Montréal 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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Advanced Endo-therapeutic Procedure : Registry-based Observational Study at the Centre Hospitalier de l'Université de Montréal (CHUM)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Group/Cohort Intervention/treatment
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.
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).

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.
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).

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.
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).

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.

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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Assess the local recurrence of polyps [ Time Frame: 6-18 months ]
    Assessment of the presence of biopsy proven neoplastic tissue at the EMR/ESD resection site for hospitalization, transfusion, a repeat endoscopy, surgery, or interventional radiology

  4. 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

  5. Assess of the number of patients with severe bleeding complications (immediate or delayed) [ Time Frame: 6-18 months ]
    Assessment of severe bleeding as defined as need for hospitalization, tranfusion, a repeat endoscopy, surgery, or interventional radiology.

  6. 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.

  7. Assess the efficacy of submucosal injectate [ Time Frame: 6-18 months ]
    Assessment of the solution volume per lesion size (ml/cm2), time of resection.

  8. 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.

  9. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117100


Contacts
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Contact: Leslie Motchum 514-890-8000 ext 30916 leslie.motchum.chum@ssss.gouv.qc.ca
Contact: Daniel von Renteln, MD,PhD danielrenteln@gmail.com

Locations
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Canada, Quebec
Centre Hospitalier Universitaire de Montréal (CHUM) Recruiting
Montréal, Quebec, Canada
Contact: Leslie Motchum    514-890-8000 ext 30916    leslie.motchum.chum@ssss.gouv.qc.ca   
Principal Investigator: Daniel von Renteln, MD         
Sub-Investigator: Erik Deslandres, MD         
Sub-Investigator: Bernard Faulques, MD         
Sub-Investigator: Audrey Weber, MD         
Sub-Investigator: Simon Bouchard, MD         
Sub-Investigator: Mickeal Bouin, MD         
Sub-Investigator: Benoit Panzini, MD         
Sub-Investigator: Justin Côté-Daigneault, MD         
Sub-Investigator: Raymond Leduc, MD         
Sub-Investigator: Sasha Sidani, MD         
Centre Hospitalier Universitaire de Montréal Recruiting
Montréal, Quebec, Canada
Contact: Leslie Motchum    514-890-8000 ext 30916    leslie.motchum.chum@ssss.gouv.qc.ca   
Contact: Daniel von Renteln, MD    514-890-8000    danielrenteln@gmail.com   
Principal Investigator: Daniel von Renteln, MD         
Sub-Investigator: Simon Bouchard, MD         
Sub-Investigator: Erik Deslandres, MD         
Sub-Investigator: Mickael Bouin, MD         
Sub-Investigator: Benoit Panzini, MD         
Sub-Investigator: Bernard Faulques, MD         
Sub-Investigator: Audrey Weber, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Daniel von Renteln, MD,PhD Centre Hospitalier Universitaire de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04117100    
Other Study ID Numbers: 17.319
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulum
Zenker Diverticulum
Colonic Polyps
Digestive System Diseases
Gastrointestinal Diseases
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Pathological Conditions, Anatomical
Intestinal Polyps
Polyps
Diverticulum, Esophageal