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Cola

t0: optical colonoscopy; Follow-up: yearly by phone call for three years

t0: colon capsule endoscopy -\> if positive: OC; At three years: OC for those patients with negative initial CC; Follow-up: yearly by phone call for 3 years

FIT yearly for two years:

t0: FIT -\> if positive : OC; t = 1 year: FIT -\> if positive : OC; t = 2 years: FIT -\> if positive : OC; At three years: OC for those patients with negative FIT during the study Follow-up: yearly by phone call for 3 years

optical colonoscopy

colon capsule endoscopy

fecal immunological test (FIT)

Jean-Christophe Saurin, Pr

olivier vinet, PhD

Sylvain Manfredi, MD

Nora Perrot, IRC

Côme Lepage, Pr

Stéphane Koch, MD

Xavier Dray, Pr

Fouzia Djenadi

Stanislas Chaussade, Pr

Jérémie Jacques, MD

Denis Sauterau, Pr

Anne Le Sidaner, MD

Romain Legros, MD

Karl Barange, MD

Stéphane Lecleire, MD

Geoffroy Vanbiervliet, MD

Céline Baud

Clément Fortier Beaulieu, MD

Slim Bramli, MD

Marilyne Grinand

Jean-Pierre Arpurt, MD

Slim Bramly, MD

Serge Bellon, MD

Alban Benezech, MD

Philippe Grandval, MD

Olivier Vinet, PhD

Emilie Del Tedesco, MD

Dupin Mélanie

Nicolas Williet, MD

Robert Benamouzig, Pr

Efficacy of colonoscopy, colon capsule and fecal immunological test for colorectal cancer screening, in first degree relatives of patients with colorectal neoplasia: a prospective randomized study.

Fecal immunological test (FIT) is the reference screening method in average risk patient. FIT is proposed every 2 years to all asymptomatic subjects with average risk aged from 50 to 74 years in France. Optical colonoscopy (OC) is the gold standard examination for patients at increased risk of colorectal cancer, like those with a first degree relative with colorectal cancer (relative risk between 2 and 4 times that of the general population). Colonoscopy should be performed in this high risk group before 50 years or 5 to 10 years before the earliest case of colorectal cancer. Optical colonoscopy has important limitations: complications (perforation, bleeding), need to use general anesthesia (in France 95% of colonoscopy are performed under general anesthesia), and low acceptability for screening even in high risk persons (40% in the best cases). In this high risk population, there is a potentially important place for alternative methods. FIT could be one of them, with already a significant amount of data suggesting its interest. No data are available in high risk French patients. Colon capsule endoscopy (CC) is a more recent technique with sparse data in this high risk group, and no prospective comparison with optical colonoscopy in this indication. Capsule endoscopy has the advantage of high feasibility, very low risk, probably (but to be demonstrated) increased acceptability, and represents the closest examination as compared to colonoscopy. This justifies a prospective study comparing in a randomized methodology these 3 modalities for the identification of advanced neoplastic lesions of the colon in well characterized group of subjects at high risk of colorectal cancer. The investigators propose a prospective, randomized protocol of non-inferiority in order to compare the two new strategies to the reference strategy for the detection of advanced colorectal neoplasia (colon or rectal cancers, large adenoma \> 1 cm or high grade dysplasia ; 1st arm: OC first; 2nd arm: CC first, OC at 3 years for those patients with negative initial CC; 3rd arm: annual FIT for 2 years (t0, t = 1 year, t = 2 years), colonoscopy at 3 years for those patients with negative FIT during the study). The new strategies will be considered non-inferior to the reference strategy if the study allows to conclude that the absolute reduction of the proportion of detected patients is not greater than 3% in comparison to the reference strategy.

Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening

Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening, in First Degree Relatives of Patients With Colorectal Neoplasia: a Prospective Randomized Study.

Percentage of patient having experienced a significant complication from any screening strategy

Cumulative costs of each strategy compared to the detection of advanced neoplasia/cost per advanced neoplasia detected and cost/life-years gained.

Quality assessment of colonoscopy and capsule endoscopy by analysing the rate of completion of colonoscopy and capsule endoscopy, and the caecal intubation rate.

The main objective of the study is to compare two alternative methods (CC anf FIT) to OC in term of non-inferiority for the detection of advanced colorectal neoplasia (adenoma \> 1 cm, adenoma with high grade dysplasia) or cancer. The method of the unilateral confidence interval of the difference will be used to test the non-inferiority. The strategies will be considered to be equivalent if the 95% confidence interval of the difference or the detection of advanced neoplasia won't exceed ±3%.

The rate of colorectal cancer identified by each strategy (= number of cancer identified by the strategy/number of patients for the strategy) will be calculated at the different steps of the study (t = first exam, t = yearly follow-up and/or interval colonoscopy, t = 3 years upon control colonoscopy) and over the full duration of the study. The rate of initial colorectal cancer, interval colorectal cancer, colorectal cancer at t=3 years and colorectal cancer identified over the duration of the study, respectively, have the same unit, i.e. the number of cancer identified by the strategy/number of patients for the strategy.

National Cancer Institute, France

Medtronic

Hôpital Edouard Herriot

Professor

water infusion in lieu of air insufflation for screening colonoscopy

water infusion colonoscopy

Joseph Leung, MD

Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.

Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.

Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients.

Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.

Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.

Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.

Limitations: Single VA site, older male population

RCT of Air Insufflation Versus Water Infusion Colonoscopy

A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.

East Bay Institute for Research and Education

Joseph Leung, M.D.

Symptoms and General Pathology

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

optical (conventional / endoscopic) colonoscopy

Fecal occult blood test

Virtual colonoscopy

Optical colonoscopy

John J You, MD MSc FRCPC

Colon cancer is the second leading cause of cancer death in North America. These deaths are preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and standard (optical) colonoscopy are all options for colon cancer screening, but it is not known which is the best at preventing death from colon cancer. A large study comparing these three tests is desperately needed. In this pilot study, the investigators want to find out what percentage of patients will show up for their screening test once enrolled. This will provide crucial information for the successful execution of the larger study.

Pilot Study of Colon Cancer Screening Tests

Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study

McMaster University

Hamilton Health Sciences Corporation

Assistant Professor

Patients with suspected colorectal cancer will undergo optical colonoscopy as the initial imaging modality.

Patients with suspected colorectal cancer will undergo Computed Tomography Colonography (CTC) as the initial imaging modality. Subsequent imaging might be required based on the findings from the CTC scan.

Patients with suspected colorectal cancer in this group will undergo Optical Colonoscopy as the initial imaging modality.

Patients with suspected colorectal cancer in this group will undergo Computed Tomography Colonography (CTC) as the initial imaging modality. Subsequent imaging might be required based on the findings from the CTC scan, i.e. patients with medium to large polyps or colorectal cancer will undergo Optical Colonoscopy as the second imaging test.

Bharti Malhotra, MSc

Tiago Rua, MSc

Bharti Malhotra

Tiago Rua

Nyree Griffin, MD

This study aims to evaluate whether the use of Computed Tomography Colonography (CTC) for patients with low to intermediate risk of suspected colorectal cancer decreases overall NHS costs and waiting times whilst increasing patient satisfaction compared to clinical practice with utilisation of Optical Colonoscopy.

Given the recent change in the NICE guidance for the cancer pathway referral for patients with suspected colorectal cancer (See NG12), there will be an increase in demand for optical colonoscopy. Optical colonoscopy is technically difficult, resource intensive and associated with complications; therefore the increased use of CT Colonography (CTC) should be considered as an alternative. The diagnostic efficacy of CTC, in comparison to optical colonoscopy, is well established and has been shown to be accurate for identifying malignancies and medium to large polyps (≥6mm) with a greater level of patient acceptability.

The use of CTC as the first diagnostic imaging tool would identify those patients who would benefit from further investigation (colonoscopy or flexible sigmoidoscopy) to occur on the same day, as well as ruling out those who do not require further testing. This would then ensure that colonoscopy capacity can be prioritised appropriately to support the increase in demand due to the NICE guidance changes.

CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer

Observational Study to Compare the Utilisation of CT Colonography With Optical Colonoscopy as the First Diagnostic Imaging Tool in Patients With Suspected Colorectal Cancer

The primary outcome of this study is to investigate whether the investigation of patients with suspected colorectal cancer using CTC as the first diagnostic imaging tool is cost-saving at 3 months compared to optical colonoscopy.

This secondary outcome aims to investigate whether the investigation of patients with suspected colorectal cancer using CTC as the first diagnostic imaging tool is cost-saving at 6 months compared to optical colonoscopy.

This secondary objective is aimed at evaluating whether the use of CTC as the initial imaging modality for patients with suspected colorectal cancer is cost-effective at 3 months compared to the use of Optical Colonoscopy.

This secondary objective is aimed at evaluating whether the use of CTC as the initial imaging modality for patients with suspected colorectal cancer is cost-effective at 6 months compared to the use of Optical Colonoscopy.

CTC has the potential to investigate other intra-abdominal organs that are not seen with optical colonoscopy. Hence, CTC scans might lead to extracolonic findings. This outcome aims to evaluate the percentage of CTC scans that lead to clinically significant findings.

The likelihood ratio of CTC against colonoscopy in patients with initial positive CTC findings will be assessed using Colonoscopy as the gold standard.

This objective will measure the time elapsed from the referral to either Colonoscopy or CTC and the time: 1) the test is actually performed; 2) a definitive diagnosis is reached (Optical Colonoscopy will be considered the gold standard for patients presenting positive findings in the initial CTC); and 3) the treatment decision is reached.

This objective aims to estimate the Do not Attend (DNA) or On the Day Cancellation (ODC) rate associated with the pathway using Colonoscopy or CTC as the initial imaging test. Given that the bowel preparation associated with CTC is easily tolerated, it is anticipated that the increase in CTC utilisation will lead to a decrease in DNA and ODC rates.

To evaluate and compare the levels of patient satisfaction associated with the two pathways: i) with CTC as the initial imaging scan; and ii) with Optical Colonoscopy as the initial imaging scan. Two patient satisfaction questionnaires (on the day and 3 months following the CTC/Optical Colonoscopy test) will be used to quantify patient satisfaction.

This objective aims to evaluate the patient's self-perceived quality of life associated with both pathways using a standard questionnaire (EQ-5D-5L).

The second outcome is to evaluate the cost per correctly diagnosed medium to large polyps (≥6mm) and colorectal cancer using CTC as the initial investigation.

For patients with positive findings on CTC (either medium to large polyps and/or CRC), optical colonoscopy will be used as the comparator to assess whether the initial diagnosis with CTC was correct.

King's College London

Guy's and St Thomas' NHS Foundation Trust

Examination of the colon with a colonoscope

A computerized X-ray that may find out if there are polyps or cancers and also pictures the contents of the abdomen and pelvis

CT-Colonography

David S Weinberg, MD

The goal of this study is to compare the findings of virtual (CT-colonography) with findings of optical colonoscopies to determine if virtual colonoscopy is suitable for colorectal cancer surveillance.

The goal of this study is to compare, both clinically and from a cost-effectiveness perspective, virtual or CT-C (CT-Colonography) to standard CT scan and optical colonoscopy (OC). Virtual colonoscopy is a combination of a radiologic evaluation of the abdomen and pelvis with intra-colonic imaging. Previous research supports the concept that CT-C may be an effective substitute for the current OC and address limited compliance for surveillance for CRC survivors. Post-operative CRC surveillance strategies are effective, but depend upon patient compliance which is less than desired. Improved adherence is linked with greater cost-effectiveness as well as better clinical outcomes. CT-C possesses potential advantages: convenience as a single test, less risk, possibly patient preference and lower total costs. Costs would be reduced through direct (provision of fewer optical colonoscopies) and indirect means (reduction in time lost from work by patient and chaperone, etc.). When extrapolated across the roughly 200,000 OCs performed annually in the US for this indication reduced utilization of even 50% in a high unit cost procedure like OC would yield substantial savings without a reduction in clinical quality.

Comparative Effectiveness of CTC & OC

Comparative Effectiveness of Virtual and Optical Colonoscopy for Colorectal (CRC) Surveillance

To evaluate the test characteristics (sensitivity, specificity, positive and negative predictive value) of CT colonography (CT-C) for detecting colorectal adenomas and cancers in the post-CRC resection surveillance setting, using optical colonoscopy (OC) as the reference standard.

Compare the costs and outcomes, from third party payor and societal perspectives, of CT-C versus independent OC plus CT for post CRC resection surveillance, using standard methods of cost-effectiveness analysis.

Fox Chase Cancer Center

Water Infusion in lieu of Air Insufflation Colonoscopy

Colonoscopy for colorectal cancer screening

Water Infusion Colonoscopy

Conventional colonoscopy with air insufflation

Air insufflation colonoscopy

Our aim is to perform a randomized-controlled trial comparing air insufflation sedated colonoscopy (conventional method) vs. water infusion sedated colonoscopy (study method) by supervised trainees. Randomized trials demonstrating reduced need for sedation medications without compromising patients' comfort, cecal intubation rates or polyps detection may cause a paradigm shift and positively alter the way traditional colonoscopy is performed and future endoscopists are trained.

Background: A novel water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without medications and significantly increased successful cecal intubation from 76% to 97% in patients accepting scheduled unsedated colonoscopy.

Aim: To perform a randomized controlled trial comparing air insufflation (conventional method) vs. water infusion in lieu of air (study method) colonoscopy in minimally sedated patients by supervised trainees.

Hypothesis: Compared with the conventional method, patients examined by the study method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.

Setting: Outpatient colonoscopy in a single VA hospital Methods: After informed consent and standard bowel preparation, patients received pre-medications administered as 0.5 increment of Fentanyl (25 μg) and 0.5 increment of Versed (1 mg) plus 50 mg Diphenhydramine. The conventional and the study method for colonoscopy were implemented as previously described. Additional pain medications were administered at the patients' request.

Outcome measures: Increments of medications, pain scores, cecal intubation and willingness to repeat colonoscopy.

Limitations: Single VA site, older male population

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening	NCT02738359	Colon Cancer Rectum Cancer	optical colonos... colon capsule e... fecal immunolog...	45 Years -	Hôpital Edouard Herriot
RCT of Air Insufflation Versus Water Infusion Colonoscopy	NCT00785889	Colorectal Canc...	water infusion ...	45 Years - 75 Years	East Bay Institute for Research and Education
Pilot Study of Colon Cancer Screening Tests	NCT00865527	Colorectal Canc... Colon Cancer Adenomatous Pol...	Fecal occult bl... Virtual colonos... Optical colonos...	50 Years - 70 Years	McMaster University
RCT of Air Insufflation Versus Water Infusion Colonoscopy	NCT00785889	Colorectal Canc...	water infusion ...	45 Years - 75 Years	East Bay Institute for Research and Education
CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer	NCT02820389	Colorectal Canc...	Optical colonos... CTC	40 Years -	Guy's and St Thomas' NHS Foundation Trust
Comparative Effectiveness of CTC & OC	NCT02143115	Colorectal Canc...	Optical colonos... CT-Colonography	18 Years -	Fox Chase Cancer Center
CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer	NCT02820389	Colorectal Canc...	Optical colonos... CTC	40 Years -	Guy's and St Thomas' NHS Foundation Trust
RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees	NCT00841282	Colorectal Canc...	Colonoscopy for... Water Infusion ... Air insufflatio...	50 Years - 80 Years	East Bay Institute for Research and Education

Spots Global Cancer Trial Database for optical colonoscopy