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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Enrolling

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

Treatments: Procedure: Polypectomy or myotomy

Study type: Observational

Funder types: Other

Identifiers

NCT04117100

2018-7692/17.319

Details and patient eligibility

About

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).

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 4 patient groups

Endoscopic mucosal resection (EMR)

Description:

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.

Treatment:

Procedure: Polypectomy or myotomy

Endoscopic mucosal dissection (ESD)

Description:

This technique uses submucosal injection and special knives to make a peri-lesional circumferential incision, followed by dissection through the submucosal sub-lesion.

Treatment:

Procedure: Polypectomy or myotomy

Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC)

Description:

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.

Treatment:

Procedure: Polypectomy or myotomy

Per Oral Endoscopic Myotomy (POEM)

Description:

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.

Treatment:

Procedure: Polypectomy or myotomy