Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

Large Polyp Study (LPS) III - Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Colonic Polyp; Colonoscopy; Complication; Duodenal Polyp

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Heiko Pohl, MD; Phone Number: 8022959363; Email: heiko.pohl@va.gov
• Study Contact Backup: Name: Laura L Jensen, MPH; Phone Number: 6953 802-295-9363; Email: Laura.Jensen@va.gov

Study Locations

• United States
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • Recruiting
      • White River Junction VAMC
      • Contact: Heiko Pohl, MD; Phone Number: 802-295-9363; Email: heiko.pohl@va.gov
      • Contact: Laura L Jensen, MPH; Phone Number: 6953 8022959363; Email: Laura.Jensen@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perforation	Defined as a complete hole, or full-thickness resection of the muscularis propria (Sydney Classification of Deep Mural Injury Type IV)	Up to 14 days following the procedure.
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.	Following the procedure up to 14 days.
Efficacy of submucosal injectate	Volume of solution per lesion size (mL/cm2), time of resection.	During the procedure.
Intraprocedural bleeding	Immediate bleeding that requires endoscopic intervention to stop the bleeding (e.g. clip placement or snare tip soft coagulation or coagulation grasper).	During the procedure
Need for colon resection	Patients who require surgery for polyp removal or as a result of complications related to the EMR or follow up procedures.	Up to 3 years following the procedure.
Technical skill of the endoscopist	To perform video based assessment of endoscopic resection skills	During the procedure
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.	Up to 14 days following the procedure.
Cold snare of duodenal adenomas greater than 10 mm	Safety, efficacy, recurrence of neoplastic polyp at first surveillance endoscopy, serious adverse events	Up to 3 years following baseline procedure
Cold snare of Paris IIa polyps greater than 20 mm	Safety, efficacy, recurrence, serious adverse events	1 year following baseline procedure

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Investigators: Principal Investigator: Heiko Pohl, MD, White River Junction Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Intestinal Polyps; Recurrence; Polyps; Colonic Polyps
• Other Study ID Numbers: CPHS 23578

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No