The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs.
The hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed.
For participants with planned EMR, endoscopists will perform EMRs as per standard of care and:
* prophylactic defect closure will either not be performed (control group), or will be performed (experimental group); * then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event; * finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.
adult ≥18 years old
patients undergoing EMR for a large (≥20mm) colorectal LSL
patients providing written and informed consent for study participation.
inflammatory bowel disease;
non-elective colonoscopy;
poor general health (American Society of Anesthesiologists classification >III);
coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets <50 x 109/L);
Parallel
Prophylactic defect closure
Procedure/SurgeryEndoscopists will use at least one new generation closure device to approximate the healthy mucosal surrounding the submucosal defect to ensure complete defect closure. Adequate apposition of the mucosal defect margins will be achieved when no visible submucosal areas \>3 mm along the closure line are present.
No prophylactic defect closure
Procedure/SurgeryAfter performing EMR with thermal ablation, prophylactic defect closure will not be performed.
Delayed bleeding
Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention.
Delayed perforation
Defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract
Any delayed bleeding
Defined as blood per rectum after the procedure
Clinically significant delayed bleeding in the proximal colon
Defined as proximal to the splenic flexure
Clinically significant delayed bleeding in the distal colon
The distal colon is defined as splenic flexure and distal
Lesion recurrence
Lesion recurrence at 6 months' follow-up defined by pathology-confirmed hyperplastic, serrated or adenomatous histology at the tattooed resection site
Defect closure time
Time for defect closure
Technical success for complete defect closure
Defined as adequate apposition of the mucosal defect margins without visible submucosal areas \>3 mm along the closure line
Procedure costs
Costs associated with procedures
Technical success of margin and/or base ablation
Defined as achieving a complete uninterrupted ring of circumferential margin ablation for margin ablation, and achieving 100% surface ablation of the resection base for base ablation
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Dartmouth-Hitchcock Medical Center
Collaborator
Charles LeMoyne Hospital
Collaborator
London Health Sciences Centre
Collaborator
St. Paul's Hospital, Canada
Collaborator
University of Toronto
Collaborator
Froedtert Hospital
Collaborator
