Colonic PolypNCT04220905
Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
An observational study of Colonic Polyp and Colonoscopy, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colonoscopy, Complication
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to May 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any patient who is known to have a large colorectal polyp or duodenal polyp and are referred for resection of the polyp.
Who may be able to join
- 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
Who cannot join
- Patients who are receiving an emergency endoscopy
- Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
- Poor bowel preparation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
White River Junction VAMC
White River Junction, Vermont, 05009
Heiko Pohl, MD, 802-295-9363, heiko.pohl@va.gov
Laura L Jensen, MPH, 8022959363 ext. 6953, Laura.Jensen@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonic Polyp, Colonoscopy, Complication, Recurrence, Duodenal Polyp
- Medical subject headings
- Colonic Polyps, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the procedure
Polyp recurrence
Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance endoscopy following complete polyp resection.
Measured: Up to 5 years (at next scheduled surveillance colonoscopy).
Secondary outcomes (9)
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.
Measured: Up to 14 days following the procedure.
Perforation
Defined as a complete hole, or full-thickness resection of the muscularis propria (Sydney Classification of Deep Mural Injury Type IV)
Measured: 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.
Measured: Following the procedure up to 14 days.
Efficacy of submucosal injectate
Volume of solution per lesion size (mL/cm2), time of resection.
Measured: 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).
Measured: 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.
Measured: Up to 3 years following the procedure.
Technical skill of the endoscopist
To perform video based assessment of endoscopic resection skills
Measured: During the procedure
Cold snare of duodenal adenomas greater than 10 mm
Safety, efficacy, recurrence of neoplastic polyp at first surveillance endoscopy, serious adverse events
Measured: Up to 3 years following baseline procedure
Cold snare of Paris IIa polyps greater than 20 mm
Safety, efficacy, recurrence, serious adverse events
Measured: 1 year following baseline procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Nov 2017
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center
- Investigators
- Heiko Pohl, MD, Principal investigator, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220905
- Sponsor's protocol ID
- CPHS 23578
- Status last verified
- Jul 2024
- First submitted
- 27 Dec 2019
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Polyp Study (LPS) III - Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04220905
- Acronym / sponsor ID
- CPHS 23578
- Conditions
- Colonic Polyp, Colonoscopy, Complication, Recurrence, Duodenal Polyp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who is known to have a large colorectal polyp or duodenal polyp and are referred for resection of the polyp.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients who are receiving an emergency endoscopy
- Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
- Poor bowel preparation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of severe complications
Time frame: Up to 14 days following the procedure.
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.
Completeness of polyp resection
Time frame: During the procedure
Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.
Polyp recurrence
Time frame: Up to 5 years (at next scheduled surveillance colonoscopy).
Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance endoscopy following complete polyp resection.
9 secondary outcomes
Severe bleeding complications
Time frame: Up to 14 days following the procedure.
Perforation
Time frame: Up to 14 days following the procedure.
Postpolypectomy syndrome
Time frame: Following the procedure up to 14 days.
Efficacy of submucosal injectate
Time frame: During the procedure.
Intraprocedural bleeding
Time frame: During the procedure
Need for colon resection
Time frame: Up to 3 years following the procedure.
Technical skill of the endoscopist
Time frame: During the procedure
Cold snare of duodenal adenomas greater than 10 mm
Time frame: Up to 3 years following baseline procedure
Cold snare of Paris IIa polyps greater than 20 mm
Time frame: 1 year following baseline procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiko Pohl, MD principal investigator
White River Junction Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyp and Colonoscopy, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heiko Pohl, MD (8022959363, heiko.pohl@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe complications (time frame: Up to 14 days following the procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.