Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

NCT04220905 | Recruiting

• 1 other identifier: CPHS 23578
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp; Colonoscopy; Complication; Recurrence; Duodenal Polyp

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 14 days following the procedure.

• 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.

  During the procedure

• Polyp recurrence

  Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance endoscopy following complete polyp resection.

  Up to 5 years (at next scheduled surveillance colonoscopy).

Secondary Outcomes (9)

• Severe bleeding complications

  Up to 14 days following the procedure.

• Perforation

  Up to 14 days following the procedure.

• Postpolypectomy syndrome

  Following the procedure up to 14 days.

• Efficacy of submucosal injectate

  During the procedure.

• Intraprocedural bleeding

  During the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with a ≥20mm colon polyp
• Patients with a ≥10mm duodenal polyp

You may not qualify if:

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

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead

Study Sites (1)

White River Junction VAMC

White River Junction, Vermont, 05009, United States

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Heiko Pohl, MD

  White River Junction Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heiko Pohl, MD

CONTACT

8022959363; heiko.pohl@va.gov

Laura L Jensen, MPH

CONTACT

802-295-9363; Laura.Jensen@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Dartmouth College

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 7, 2020
• Study Start: November 1, 2017
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

US (1)