Advanced Endo-therapeutic Procedure : Registry-based Observational Study

NCT04117100 | Recruiting

• 1 other identifier: 2018-7692/17.319
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (20)

• 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

• 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.

  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

  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 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

• 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

• Technical skill of the endoscopist

  Video based assessment of endoscopic resection skills

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6-18 months

• Time to recurrence

  The interval between the date of initial curative treatment and the detection of local recurrence or distant metastasis.

  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.

  6-18 months

Study Arms (4)

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

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

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

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

Interventions

Polypectomy or myotomy PROCEDURE

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); Endoscopic mucosal resection (EMR); Per Oral Endoscopic Myotomy (POEM); Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \>18 years
• Presenting for an elective advanced therapeutic endoscopy (ESD, EMR, advanced polypectomy, POEM or Zenker treatment)
• Signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier Universitaire de Montréal (CHUM)

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Zenker Diverticulum; Colonic Polyps; Colonic Neoplasms

Interventions

Myotomy

Condition Hierarchy (Ancestors)

Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Polyps; Polyps; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Daniel von Renteln, MD,PhD

  Centre Hospitalier Universitaire de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel von Renteln, MD, PhD

CONTACT

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

Samira Hanin

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist, Principal Scientist, MD, PhD

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: October 7, 2019
• Study Start: June 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

CA (1)