Standard Colonoscopy for Colon Adenomas

(SSL follow-up Trial)

Overseen By Julie Fleury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Inflammatory bowel disease, Hereditary CRC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

730 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Standard Colonoscopy for Colon Adenomas?

Standard colonoscopy is highly effective for detecting and treating colon adenomas, which are growths that can lead to cancer. It is considered the best method for finding these growths, and removing them during the procedure can lower the risk of developing colorectal cancer. ^{1 2 3 4 5}

Is standard colonoscopy generally safe for humans?

Colonoscopy is generally considered a safe procedure with a low rate of major adverse events like bleeding and perforation. However, minor issues such as abdominal pain and infection can occur, and serious events are more common when additional procedures like polypectomy are performed. ^{6 7 8 9 10}

How does standard colonoscopy differ from other treatments for colon adenomas?

Standard colonoscopy is unique because it is the gold standard for detecting pre-malignant lesions like adenomas, but it can miss some due to limitations in visualizing certain areas of the colon. Unlike other treatments, it involves direct visual examination and removal of polyps, but its effectiveness can be affected by factors like bowel preparation and anatomical challenges. ^{3 11 12 13 14}

What is the purpose of this trial?

The primary aim of this study is to determine the rate of total metachronous advanced neoplasia (TMAN) detection after index detection of serrated lesions (SL) \[sessile serrated polyps (SSPs), traditional serrated adenomas (TSAs)\], and metachronous high-risk adenoma (HRA) after index detection of high-grade dysplasia (HGD). We will use the database of patients diagnosed with SL or HGD at index colonoscopy with a delay in surveillance and determine the risk of advanced lesions (especially high-risk lesion and CRC detection) of these delayed colonoscopies. The aim is to determine the effects of breach of continuity of care in these patients.

Research Team

Daniel von Renteln, Md

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

This trial is for people aged 45-80 who had a colonoscopy at CHUM between 2009 and 2022, found to have serrated lesions (SL) or high-grade dysplasia (HGD), and are due for follow-up. It's not for those with certain genetic syndromes, inflammatory bowel disease, colorectal cancer at first checkup, short life expectancy, or too early for next colonoscopy.

Inclusion Criteria

I am aged 45-80 and had a colonoscopy at CHUM between 2009-2022 with findings but missed my follow-up.

Exclusion Criteria

Patients with a life expectancy too short to benefit from colonoscopy

I was diagnosed with colorectal cancer during a colonoscopy.

I have been diagnosed with inflammatory bowel disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo standard colonoscopy with removal of optically diagnosed polyps for histopathological evaluation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for the rate of metachronous advanced neoplasia detection after index detection of serrated lesions and high-grade dysplasia

1 year

Periodic follow-up visits as per standard clinical follow-up

Long-term Surveillance

Participants may undergo additional follow-up colonoscopies based on surveillance intervals recommended by guidelines

3-10 years

Treatment Details

Interventions

• Standard Colonoscopy

Trial Overview The study looks at how often high-risk adenomas come back after finding SL or HGD during a standard colonoscopy. Researchers will track details like polyp characteristics and removal success to understand the risk of future serious issues in the colon.

Participant Groups

Group I: Colonoscopy Experimental Treatment 1 Intervention

Standard colonoscopy: All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Findings from Research

This study is a prospective, multicenter, randomized controlled trial involving 1772 patients to compare the adenoma detection rate between Endocuff Vision™-assisted colonoscopy and standard colonoscopy, aiming to improve the quality of bowel cancer screening.

The trial will provide important insights into the effectiveness of Endocuff Vision™ in enhancing adenoma detection rates, which is crucial for reducing the incidence of interval cancers and improving overall patient outcomes in colonoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ADENOMA Study. Accuracy of Detection using Endocuff Vision™ Optimization of Mucosal Abnormalities: study protocol for randomized controlled trial. Bevan, R., Ngu, WS., Saunders, BP., et al.[2022]

Colonoscopy is not only the gold standard for detecting colorectal adenomas but also serves as an effective treatment method, significantly reducing the risk of colorectal cancer.

Various advanced endoscopic resection techniques, such as endoscopic mucosal resection and endoscopic submucosal dissection, are available and are guided by recent recommendations from the European Society of Gastrointestinal Endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic management of colorectal adenomas. Meier, B., Caca, K., Fischer, A., et al.[2020]

Balloon-assisted colonoscopy significantly improved the detection rate of simulated polyps compared to standard colonoscopy, with a detection rate of 91.7% versus 45.8% in a controlled colon model study involving 50 gastroenterologists.

This technique was particularly effective in identifying both non-obscured and obscured polyps, suggesting it could reduce the adenoma miss rate in real clinical settings, warranting further studies in human participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel balloon colonoscope detects significantly more simulated polyps than a standard colonoscope in a colon model. Hasan, N., Gross, SA., Gralnek, IM., et al.[2014]

In a study of 32,535 patients, higher adenomas per colonoscopy (APC) were associated with a significantly lower risk of postcolonoscopy colorectal cancer (PCCRC), indicating that APC may be a better quality measure for colonoscopy than adenoma detection rate (ADR).

Endoscopists with an ADR of at least 25% but an APC of less than 0.50 had a higher risk of PCCRC, suggesting that focusing on APC could help identify and improve detection performance in colonoscopy quality improvement programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopist Adenoma Per Colonoscopy Detection Rates and Risk for Post Colonoscopy Colorectal Cancer: Data From New Hampshire Colonoscopy Registry. Anderson, JC., Rex, DK., Mackenzie, TA., et al.[2023]

Long-term follow-up from the National Polyp Study indicates that colonoscopy significantly reduces overall mortality, colorectal cancer death rates, and incidence of colorectal cancer, highlighting its critical clinical benefits.

Improving adenoma detection rates during colonoscopy is essential for maximizing these benefits, and specific techniques such as careful inspection, washing the colon surface, and using advanced technologies can enhance detection and training for endoscopists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced colorectal polyp detection techniques. Qumseya, BJ., Wallace, MB.[2021]

Colonoscopy is generally considered a low-risk procedure, but adverse events (AEs) such as bleeding, perforation, and mortality are important clinical considerations that need to be addressed.

This document provides updated estimates of serious AEs related to colonoscopy and specific interventions like endoscopic mucosal resection (EMR), highlighting the need for awareness and careful monitoring during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ASGE review of adverse events in colonoscopy. Kothari, ST., Huang, RJ., Shaukat, A., et al.[2020]

Colonoscopy is generally safe, with an adverse event rate of 2.8 per 1000 procedures, but serious complications like hemorrhage and perforation are more common when polypectomy is performed.

The article emphasizes the importance of preventing and managing adverse events specifically related to polypectomy and endoscopic mucosal resection of colonic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. Sethi, A., Song, LM.[2022]

A case was reported where a malfunctioning colonoscope caused mucosal injury during a screening colonoscopy due to a high-pressure water jet, highlighting a rare but serious device-related adverse event.

This incident emphasizes the importance of endoscopist awareness regarding potential equipment malfunctions, as the patient was found to have normal mucosa upon repeat colonoscopy with a functioning device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colon mucosal injury caused by water jet malfunction during a screening colonoscopy: A case report. Patel, P., Chen, CH.[2022]

In a study of 49,445 outpatient colonoscopies, 489 adverse events (AEs) were attributed to the procedure, resulting in an overall AE rate of 9.9‰, highlighting the importance of recognizing and reporting these events accurately.

While most AEs were non-fatal, 10 were fatal, with only one directly related to the procedure (a perforation), indicating that both procedure-related and non-procedure-related risks exist and may be underreported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonoscopy adverse events: are we getting the full picture? Pedersen, L., Sorensen, N., Lindorff-Larsen, K., et al.[2021]

A structured assessment of 1,144 patients who underwent colonoscopy revealed that nearly 30% reported definite-related minor adverse events, and about 3% experienced major adverse events, indicating that post-procedural complications are more common than previously thought.

Patients who experienced definite-related adverse events were less likely to be willing to return for future colonoscopies and had a less positive overall experience, highlighting the importance of addressing these events to improve patient satisfaction and compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. de Jonge, V., Sint Nicolaas, J., van Baalen, O., et al.[2015]

In a study of 1600 patients undergoing colonoscopy, 260 were found to have polyps, with the highest incidence in individuals aged 51-65 years, highlighting the importance of regular screening in this age group.

Adenomatous polyps were the most common type found (58.3%), and early detection of these polyps is crucial for improving treatment outcomes, as they can be precursors to colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of colonoscopy data for colorectal polyps and associated histopathological findings. Kazem Shahmoradi, M., Soleimaninejad, M., Sharifian, M.[2022]

Colonoscopy is highly effective in detecting and removing polyps, with 22.1% of procedures resulting in polypectomies, and a total of 1184 polyps removed, including 882 adenomas, some of which were advanced pathology.

The procedure demonstrated a low complication rate, with only 1.7% of polypectomies resulting in post-polypectomy bleeding, and only two cases requiring surgical intervention, highlighting its safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonoscopic polypectomy--evaluation of the effectiveness and safety (single center experience). Peterlejtner, T., Szewczyk, T., Buczyńska, E., et al.[2019]

In a study of 8,193 participants undergoing screening colonoscopy, inadequate bowel preparation was linked to a significant reduction in the detection of nonadvanced adenomas (NAAs), particularly in the proximal colon, with a prevalence rate ratio of 0.86 compared to those with good preparation.

The findings highlight the importance of ensuring high-quality bowel cleansing before colonoscopy, as poor preparation can lead to missed diagnoses of colorectal neoplasms, emphasizing the need for improved practices in routine screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Inadequate Bowel Cleansing on Colonoscopic Findings in Routine Screening Practice. Niedermaier, T., Amitay, EL., Gies, A., et al.[2022]

In a study involving 100 patients undergoing colonoscopy, routine retroflexion of the proximal colon did not significantly improve adenoma detection rates compared to standard forward view examinations.

The miss rates for adenomas were 33.3% in the forward view and 23.7% in the retroflexed view, but the difference was not statistically significant, suggesting that retroflexion may not be necessary for improving detection of small adenomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of proximal colon retroflexion on adenoma miss rates. Harrison, M., Singh, N., Rex, DK.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The ADENOMA Study. Accuracy of Detection using Endocuff Vision™ Optimization of Mucosal Abnormalities: study protocol for randomized controlled trial. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Endoscopic management of colorectal adenomas. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A novel balloon colonoscope detects significantly more simulated polyps than a standard colonoscope in a colon model. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Endoscopist Adenoma Per Colonoscopy Detection Rates and Risk for Post Colonoscopy Colorectal Cancer: Data From New Hampshire Colonoscopy Registry. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Advanced colorectal polyp detection techniques. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

ASGE review of adverse events in colonoscopy. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Colon mucosal injury caused by water jet malfunction during a screening colonoscopy: A case report. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Colonoscopy adverse events: are we getting the full picture? [2021]

10. United States pubmed.ncbi.nlm.nih.gov

The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Evaluation of colonoscopy data for colorectal polyps and associated histopathological findings. [2022]

12. Poland pubmed.ncbi.nlm.nih.gov

Colonoscopic polypectomy--evaluation of the effectiveness and safety (single center experience). [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Impact of Inadequate Bowel Cleansing on Colonoscopic Findings in Routine Screening Practice. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Impact of proximal colon retroflexion on adenoma miss rates. [2022]