Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWhite River Junction Veterans Affairs Medical Center
About this trial
This protocol describes a prospective cohort study. It addresses an important challenge in the prevention of colorectal cancer and duodenal cancer: how to safely and effectively remove large polyps.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Any patient ≥18 who presents for an upper endoscopy or colonoscopy and who does not have criteria for exclusion
Patients with a ≥20mm colon polyp
Patients with a ≥10mm duodenal polyp
Disqualifiers
Patients who are receiving an emergency endoscopy
Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
Poor bowel preparation
Pregnancy
Trial population
Any patient who is known to have a large colorectal polyp or duodenal polyp and are referred for resection of the polyp.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of severe complications
Aggregate of all severe adverse events that occur at the time of the procedure or during and up to 14 days of follow-up. Severe adverse events include bleeding, perforation, postpolypectomy syndrome, and clinical events that require an admission to the hospital.
Time frame
Up to 14 days following the procedure.2
Completeness of polyp resection
Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.
Time frame
During the procedure3
Polyp recurrence
Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance endoscopy following complete polyp resection.
Time frame
Up to 5 years (at next scheduled surveillance colonoscopy).Secondary outcomes
1
Severe bleeding complications
Severe bleeding is defined as the need for hospitalization, transfusion, a repeat endoscopy, surgery, or interventional radiology, up to 14 days following the procedure.
Time frame
Up to 14 days following the procedure.2
Perforation
Defined as a complete hole, or full-thickness resection of the muscularis propria (Sydney Classification of Deep Mural Injury Type IV)
Time frame
Up to 14 days following the procedure.3
Postpolypectomy syndrome
Defined as abdominal pain severe enough to warrant an ED visit or hospital admission and presence of leukocytosis and/or required treatment with antibiotics.
Time frame
Following the procedure up to 14 days.4
Efficacy of submucosal injectate
Volume of solution per lesion size (mL/cm2), time of resection.
Time frame
During the procedure.Sponsors and contacts
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Source ClinicalTrials.gov