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Colorectal cancer prevention by a CLEAR principles-based colonoscopy protocol: an observational study.

ABSTRACT: BACKGROUND AND AIMS:Colorectal cancer (CRC) prevention by colonoscopy has been lower than expected. We studied CRC prevention outcomes of a colonoscopy protocol based on Clean the colon, Look Everywhere, and complete Abnormality Removal (CLEAR) principles. METHODS:This observational follow-up study studied patients provided screening colonoscopy at a free-standing private ambulatory surgery center in South Carolina by 80 endoscopists from October 2001 to December 2014, followed through December 2015. The colonoscopy protocol, optimized for polyp clearance, featured in-person bowel preparation instructions reinforced by phone, polyp search and removal throughout insertion and gradual withdrawal with circumferential tip movements, and a team approach using all personnel present to maximize polyp detection, patient safety, and clear-margin polypectomy including requesting repeat inspection or additional tissue removal. Outcome measures were postscreening lifetime CRC risk relative to Surveillance Epidemiology and End Results (SEER)-18 and interval cancer rate (postcolonoscopy CRCs among cancer-free patients at screening). RESULTS:Of 25,862 patients (mean age, 58.1 years; 52% black; 205,522 person-years of observation), 159 had CRC at screening and 67 patients developed interval CRC. The interval CRC rate was 3.34 per 10,000 person-years of observation, 5.79 and 2.24 among patients with and without adenomas, respectively. The rate was similar among older patients (mean age 68.5 years at screening) and with prolonged follow-up. Postscreening lifetime CRC risk was 1.6% (bootstrap 95% confidence interval, 1.3%-1.8%) versus 4.7% in SEER-18, 67% lower. Subgroups with mean screening ages of 50 and 68.5 years showed risk reductions of 80% and 72%, respectively. The adverse event rate was less than usually reported rates: perforation 2.6 per 10,000, bleeding with hospitalization 2.4 per 10,000, and no deaths. CONCLUSIONS:A colonoscopy protocol optimized for polyp clearance prevented 67% of CRC compared with a SEER-18 population given ongoing population screening.

SUBMITTER: Xirasagar S

PROVIDER: S-EPMC7096265 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Colorectal cancer prevention by a CLEAR principles-based colonoscopy protocol: an observational study.

Xirasagar Sudha S Wu Yuqi Y Tsai Meng-Han MH Zhang Jiajia J Chiodini Stephanie S de Groen Piet C PC

Gastrointestinal endoscopy 20191207 4

<h4>Background and aims</h4>Colorectal cancer (CRC) prevention by colonoscopy has been lower than expected. We studied CRC prevention outcomes of a colonoscopy protocol based on Clean the colon, Look Everywhere, and complete Abnormality Removal (CLEAR) principles.<h4>Methods</h4>This observational follow-up study studied patients provided screening colonoscopy at a free-standing private ambulatory surgery center in South Carolina by 80 endoscopists from October 2001 to December 2014, followed th ...[more]

PMID: 31816316

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Project description:Background & aimsColonoscopy provides incomplete protection from colorectal cancer (CRC), but determinants of post-colonoscopy CRC are not well understood. We compared clinical features and molecular characteristics of CRCs diagnosed at different time intervals after a previous colonoscopy.MethodsWe performed a population-based, cross-sectional study of incident CRC cases in Denmark (2007-2011), categorized as post-colonoscopy or detected during diagnostic colonoscopy (in patients with no prior colonoscopy). We compared prevalence of proximal location and DNA mismatch repair deficiency (dMMR) in CRC tumors, relative to time since previous colonoscopy, using logistic regression and cubic splines to assess temporal variation.ResultsOf 10,365 incident CRCs, 725 occurred after colonoscopy examinations (7.0%). These were more often located in the proximal colon (odds ratio [OR], 2.34; 95% confidence interval [CI], 1.90-2.89) and were more likely to have dMMR (OR, 1.26; 95% CI, 1.00-1.59), but were less likely to be metastatic at presentation (OR, 0.65; 95% CI, 0.48-0.89) compared with CRCs diagnosed in patients with no prior colonoscopy. The highest proportions of proximal and/or dMMR tumors were observed in CRCs diagnosed 3-6 years after colonoscopy, but these features were still more frequent among cancers diagnosed up to 10 years after colonoscopy. The relative excess of dMMR tumors was most pronounced in distal cancers. In an analysis of 85 cases detected after colonoscopy, we found BRAF mutations in 23% of tumors and that 7% of cases had features of Lynch syndrome. Colonoscopy exams were incomplete in a higher proportion of cases diagnosed within <1 year (in 38%) than in those diagnosed within 1-10 years after colonoscopy (16%).ConclusionsIn a study of incident CRC cases in Denmark, we observed that tumors found in patients who have undergone colonoscopy are more often proximal and have dMMR compared to CRCs detected in patients without previous colonoscopies. The excess of right-sided tumors and the modest independent effects of dMMR reinforce the importance of proper colonoscopic examination of the proximal large bowel.

Project description:BackgroundColorectal cancer (CRC) is the most frequent cancer in Europe. Randomized clinical trials demonstrated that screening with fecal occult blood test (FOBT) reduces mortality from CRC. Accordingly, the European Community currently recommends population-based screening with FOBT. Other screening tests, such as computed tomography colonography (CTC) and optical colonoscopy (OC), are highly accurate for examining the entire colon for adenomas and CRC. Acceptability represents a critical determinant of the impact of a screening program. We designed a randomized controlled trial to compare participation rate and diagnostic yield of FOBT, CTC with computer-aided diagnosis, and OC as primary tests for population-based screening.Methods/designA total of 14,000 subjects aged 55 to 64 years, living in the Florence district and never screened for CRC, will be randomized in three arms: group 1 (5,000 persons) invited to undergo CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation); group 2 (8,000 persons) invited to undergo a biannual FOBT for three rounds; and group 3 (1,000 persons) invited to undergo OC. Subjects of each group will be invited by mail to undergo the selected test. All subjects with a positive FOBT or CTC test (that is, mass or at least one polyp ≥ 6 mm) will be invited to undergo a second-level OC. Primary objectives of the study are to compare the participation rate to FOBT, CTC and OC; to compare the detection rate for cancer or advanced adenomas of CTC versus three rounds of biannual FOBT; to evaluate referral rate for OC induced by primary CTC versus three rounds of FOBT; and to estimate costs of the three screening strategies. A secondary objective of the study is to create a biological bank of blood and stool specimens from subjects undergoing CTC and OC.DiscussionThis study will provide information about participation/acceptability, diagnostic yield and costs of screening with CTC in comparison with the recommended test (FOBT) and OC.Trial registrationClinicalTrials.gov Identifier: NCT01651624.

Project description:ImportanceAlthough some countries have implemented widespread colonoscopy screening, most European countries have not introduced it because of uncertainty regarding participation rates, procedure-related pain and discomfort, endoscopist performance, and effectiveness. To our knowledge, no randomized trials on colonoscopy screening currently exist.ObjectiveTo investigate participation rate, adenoma yield, performance, and adverse events of population-based colonoscopy screening in several European countries.Design, setting, and populationA population-based randomized clinical trial was conducted among 94 959 men and women aged 55 to 64 years of average risk for colon cancer in Poland, Norway, the Netherlands, and Sweden from June 8, 2009, to June 23, 2014.InterventionsColonoscopy screening or no screening.Main outcomes and measuresParticipation in colonoscopy screening, cancer and adenoma yield, and participant experience. Study outcomes were compared by country and endoscopist.ResultsOf 31 420 eligible participants randomized to the colonoscopy group, 12 574 (40.0%) underwent screening. Participation rates were 60.7% in Norway (5354 of 8816), 39.8% in Sweden (486 of 1222), 33.0% in Poland (6004 of 18 188), and 22.9% in the Netherlands (730 of 3194) (P < .001). The cecum intubation rate was 97.2% (12 217 of 12 574), with 9726 participants (77.4%) not receiving sedation. Of the 12 574 participants undergoing colonoscopy screening, we observed 1 perforation (0.01%), 2 postpolypectomy serosal burns (0.02%), and 18 cases of bleeding owing to polypectomy (0.14%). Sixty-two individuals (0.5%) were diagnosed with colorectal cancer and 3861 (30.7%) had adenomas, of which 1304 (10.4%) were high-risk adenomas. Detection rates were similar in the proximal and distal colon. Performance differed significantly between endoscopists; recommended benchmarks for cecal intubation (95%) and adenoma detection (25%) were not met by 6 (17.1%) and 10 of 35 endoscopists (28.6%), respectively. Moderate or severe abdominal pain after colonoscopy was reported by 601 of 3611 participants (16.7%) examined with standard air insufflation vs 214 of 5144 participants (4.2%) examined with carbon dioxide (CO2) insufflation (P < .001).Conclusions and relevanceColonoscopy screening entails high detection rates in the proximal and distal colon. Participation rates and endoscopist performance vary significantly. Postprocedure abdominal pain is common with standard air insufflation and can be significantly reduced by using CO2.Trial registrationclinicaltrials.gov Identifier: NCT00883792.

Project description:BackgroundNo randomized, controlled trials of screening colonoscopy have been completed, and ongoing trials exclude persons aged 75 years or older. The Medicare program, however, reimburses screening colonoscopy without an upper age limit.ObjectiveTo evaluate the effectiveness and safety of screening colonoscopy to prevent colorectal cancer (CRC) in persons aged 70 to 74 and those aged 75 to 79 years.DesignLarge-scale, population-based, prospective study. The observational data were used to emulate a target trial with 2 groups: colonoscopy screening and no screening.SettingUnited States.Participants1 355 692 Medicare beneficiaries (2004 to 2012) aged 70 to 79 years at average risk for CRC who used Medicare preventive services and had no previous diagnostic or surveillance colonoscopies in the past 5 years.Measurements8-year risk for CRC and 30-day risk for adverse events.ResultsIn beneficiaries aged 70 to 74 years, the 8-year risk for CRC was 2.19% (95% CI, 2.00% to 2.37%) in the screening colonoscopy group and 2.62% (CI, 2.56% to 2.67%) in the no-screening group (absolute risk difference, -0.42% [CI, -0.24% to -0.63%]). Among those aged 75 to 79 years, the 8-year risk for CRC was 2.84% (CI, 2.54% to 3.13%) in the screening colonoscopy group and 2.97% (CI, 2.92% to 3.03%) in the no-screening group (risk difference, -0.14% [CI, -0.41 to 0.16]). The excess 30-day risk for any adverse event in the colonoscopy group was 5.6 events per 1000 individuals (CI, 4.4 to 6.8) in the 70- to 74-year age group and 10.3 per 1000 (CI, 8.6 to 11.1) in the 75- to 79-year age group.LimitationCRC-specific mortality was not available, but CRC incidence and stage were studied at diagnosis.ConclusionScreening colonoscopy may have had a modest benefit in preventing CRC in beneficiaries aged 70 to 74 years and a smaller benefit in older beneficiaries. The risk for adverse events was low but greater among older persons.Primary funding sourceNational Institutes of Health.

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Colorectal cancer prevention by a CLEAR principles-based colonoscopy protocol: an observational study.

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Colorectal cancer prevention by a CLEAR principles-based colonoscopy protocol: an observational study.

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