Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04220905
• Other study ID #: CPHS 23578
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: May 2025

Study information

• Verified date: May 2021
• Source: White River Junction Veterans Affairs Medical Center
• Contact: Heiko Pohl, MD
• Phone: 8022959363
• Email: heiko.pohl[@]va.gov
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This protocol describes a prospective cohort study. It addresses an important challenge in the prevention of colorectal cancer: how to safely and effectively remove large polyps.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient =18 who presents for a colonoscopy and who does not have criteria for exclusion

• Patients with a =20mm colon polyp

Exclusion Criteria:

• Patients who are receiving an emergency colonoscopy

• Patients with coagulopathy with an elevated INR =1.5, or platelets <50

• Poor bowel preparation

• Pregnancy

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Colonoscopy
• Complication
• Polyps
• Recurrence

Locations

Country	Name	City	State
United States	White River Junction VAMC	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
White River Junction Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	Polyp recurrence	Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance colonoscopy following complete polyp resection.	Up to 5 years (at next scheduled surveillance colonoscopy).
Secondary	Severe bleeding complications	Severe bleeding is defined as the need for hospitalization, transfusion, a repeat colonoscopy or sigmoidoscopy, surgery, or interventional radiologyUp to 14 days following the procedure.	Up to 14 days following the procedure.
Secondary	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.
Secondary	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.
Secondary	Efficacy of submucosal injectate	Volume of solution per lesion size (mL/cm2), time of resection.	During the procedure.
Secondary	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
Secondary	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.
Secondary	Technical skill of the endoscopist	To perform video based assessment of endoscopic resection skills	During the procedure