Clinical trial NCT04220905: Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
Official title: Large Polyp Study (LPS) III - Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colonic Polyp
Colonoscopy
Complication
Recurrence
Duodenal Polyp
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2020-01-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who is known to have a large colorectal polyp or duodenal polyp and are referred for resection of the polyp.

Brief summary: 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.

Detailed description: Over recent years, a number of studies have been published that have highlighted factors associated with improved efficacy and safety of large polyp resection. Almost all of these studies originate from one large Australian cohort. It is unclear, whether the results are generalizable to other populations. It is important to understand if these findings can be duplicated, to further build on the gained knowledge. At the same time the technology of endoscopic resection is evolving.

Established in 2012, the Large Polyp Study group aims to prospectively examine outcomes related to endoscopic large polyp removal. Enrollment of an ongoing randomized trial of 920 patients has just been completed and a second trial is planned. The primary aim of both trials is to understand whether a specific intervention will reduce the risk of adverse events. The added observational study will complement the trials in different ways: It will enroll patients who might not have been eligible for the trials and allow the application of other resection techniques. The observational study will therefore better represent the average patient who undergoes resection of a large polyp. Furthermore, it will add sample size to examine secondary outcomes with greater power.

This is a continuation of NCT01936948 (Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial) as a observational cohort.

The continuation was approved by the institutional IRB as part of the initial RCT. At this point the investigators document the observational arm as its own study in this registry.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who are receiving an emergency endoscopy
* Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
* Poor bowel preparation
* Pregnancy

Primary outcomes:
measure: Incidence of severe complications
timeFrame: Up to 14 days following the procedure.
measure: Completeness of polyp resection
timeFrame: During the procedure
measure: Polyp recurrence
timeFrame: Up to 5 years (at next scheduled surveillance colonoscopy).
Secondary outcomes:
measure: Severe bleeding complications
timeFrame: Up to 14 days following the procedure.
measure: Perforation
timeFrame: Up to 14 days following the procedure.
measure: Postpolypectomy syndrome
timeFrame: Following the procedure up to 14 days.
measure: Efficacy of submucosal injectate
timeFrame: During the procedure.
measure: Intraprocedural bleeding
timeFrame: During the procedure
measure: Need for colon resection
timeFrame: Up to 3 years following the procedure.
measure: Technical skill of the endoscopist
timeFrame: During the procedure
measure: Cold snare of duodenal adenomas greater than 10 mm
timeFrame: Up to 3 years following baseline procedure
measure: Cold snare of Paris IIa polyps greater than 20 mm
timeFrame: 1 year following baseline procedure
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VAMC
state: Vermont
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Heiko Pohl, MD
role: PRINCIPAL_INVESTIGATOR
References: