Advanced Endo-therapeutic Procedure : Registry-based Observational Study

Recruiting

• Conditions: Zenker Diverticulum; Colo-rectal Cancer; Polyp of Colon

• Registration Number: NCT04117100
• Lead Sponsor: 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. 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 Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the rate of completeness of neoplastic tissue resection	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	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	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	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	6-18 months	Assessment of the solution volume per lesion size (ml/cm2), time of resection.
Assess the number of patients with intraprocedural bleeding	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	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	6-18 months	Video based assessment of endoscopic resection skills
En-bloc resection rate	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	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	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	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	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	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)	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	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	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	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	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.
Assess the incidence of overall severe complications following the procedure	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.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Montréal (CHUM); 🇨🇦 Montréal, Quebec, Canada