Advanced Endo-therapeutic Procedure : Registry-based Observational Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Advanced Endo-therapeutic Procedure : Registry-based Observational Study at the Centre Hospitalier de l'Université de Montréal (CHUM)

Conditions
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Zenker Diverticulum, Polyp of Colon, Colo-rectal Cancer

Intervention / Treatment
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* Procedure: Polypectomy or myotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic mucosal resection (EMR)<br>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<br>* 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).<br>|
| Endoscopic mucosal dissection (ESD)<br>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<br>* 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).<br>|
| Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC)<br>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<br>* 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).<br>|
| Per Oral Endoscopic Myotomy (POEM)<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6-18 months | 
| Assess the local recurrence of polyps | 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 | 6-18 months | 
| Assess the presence of perforation at resection site | Assessment of the presence of a complete hole, or full-thickness resection of the muscularis propria | 6-18 months | 
| Assess of the number of patients with severe bleeding complications (immediate or delayed) | Assessment of severe bleeding as defined as need for hospitalization, tranfusion, a repeat endoscopy, surgery, or interventional radiology. | 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. | 6-18 months | 
| Assess the efficacy of submucosal injectate | Assessment of the solution volume per lesion size (ml/cm2), time of resection. | 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. | 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). | 6-18 months |