A new panenteric capsule endoscopy-based strategy in patients with melena and a negative upper gastrointestinal endoscopy: a prospective feasibility study.

OBJECTIVE: patients presenting with melena and nondiagnostic esophagogastroduodenoscopy are usually investigated with colonoscopy and if negative, with small bowel capsule endoscopy. In this pilot study, we tested feasibility and performance of panenteric capsule endoscopy (PCE) in patients presenting with melena and negative esophagogastroduodenoscopy. METHODS: Between January and December 2018, consecutive patients presenting with melena, clinically significant bleeding and negative esophagogastroduodenoscopy were invited to undergo PCE by swallowing PillCam Colon 2 (Medtronic Inc., Dublin, Ireland). PCE results, further diagnostic or therapeutic examinations, rebleeding rates at 30 days and 12 months were recorded. RESULTS: Out of 128 patients with melena, 23 had negative esophagogastroduodenoscopy. Of them, 12 (8 female, mean age 76 years) underwent PCE, which allowed complete small bowel and colonic evaluation in 12 (100%) and 11 (91.7%) patients, respectively. The small bowel and colon cleansing were adequate in 100 and 83.3%, respectively. No PCE-related complications were observed. The PCE diagnostic yield was 83.3%: significant findings were located in the small bowel, colon or both in 5 (41.7%), 4 (33.3%) and 1 (8.3%) patients, respectively. Device-assisted enteroscopy was performed in 6 (50%) patients. Thirty days and 1 year rebleeding rates were 0 and 18.1%, respectively. CONCLUSIONS: In this proof-of-concept study, PCE was feasible and safe in patients with melena and negative esophagogastroduodenoscopy, identifying the bleeding site in 83% of patients. PCE lead to small bowel therapeutic interventions in 50% of patients, thus avoiding unnecessary standard colonoscopy. Further large prospective randomized studies investigating this strategy are warranted.

MiroCam capsule for obscure gastrointestinal bleeding: a prospective, single centre experience.

BACKGROUND: Capsule endoscopy is an established tool for the evaluation of obscure gastrointestinal bleeding but published literature is mostly limited to PillCam SB (Given Imaging, Israel). AIMS: The aims of this study were to determine the findings, the diagnostic yield and the rebleeding rate in a series of patients with overt or occult obscure gastrointestinal bleeding studied with MiroCam(Intromedic, Seoul, Korea) capsule endoscopy. METHODS: Data of 118 patients who underwent capsule endoscopy for overt or occult obscure gastrointestinal bleeding were prospectively collected between March 2009 and March 2011. RESULTS: Evaluation of the entire small bowel (completion rate) was achieved in 96% of cases. Relevant lesions occurred in 58% of patients. Angiodysplasias was the most common finding. Six patients (9% of the positive findings) had a non-small-bowel lesion detected by capsule. The yield of capsule endoscopy in the overt group was greater than in the occult group but without achieving a significant difference (61% vs. 54%, p>0.05). Rebleeding rate was lower in patients with a negative examination (6%) than in patients with a positive one (17%) (p=0.03). Capsule retention was registered in 3 of 118 patients (2.5%). CONCLUSIONS: MiroCam capsule endoscopy is a safe and effective tool for exploring small bowel with a high completion rate.

Comparing different strategies for colorectal cancer screening in Italy: predictors of patients' participation.

OBJECTIVES: The objective of this study was to study predictors of patients' participation in colorectal cancer (CRC) screening. METHODS: Men and women, aged 55-64 years, were randomized to the following: (i) biennial fecal occult blood test (FOBT) delivered by mail (n=2,266); (ii) FOBT delivered by a general practitioner (GP)/screening facility (n=5,893); (iii) "once-only" sigmoidoscopy (FS) (n=3,650); (iv) FS followed by FOBT for screenees with negative FS (n=10,867); and (v) patient's choice between FS and FOBT (n=3,579). A stratified (by screening arm) random sample of attenders and nonattenders was contacted by trained interviewers 4 months after the initial invitation. Subjects giving their consent were administered a questionnaire (available online) investigating perceptions of individual CRC risk, attitudes toward prevention, adoption of health protective behaviors, and reasons for attendance/nonattendance. Adjusted prevalence odds ratios (ORs) were computed by multivariable logistic regression. RESULTS: The response rate was 71.9% (701 of 975) among nonattenders and 88.9% (773 of 870) among attenders. Adjusting for screening arm, center, gender, age, and education, participation was significantly higher among people who consulted their GP before undergoing screening (OR: 4.24; 95% confidence interval (CI): 3.11-5.78), who mentioned one first-degree relative with CRC (OR: 3.62; 95% CI: 2.02-6.49), who reported regular physical activity (OR: 1.85; 95% CI: 1.33-2.55), and who read the mailed information (letter only: OR: 1.85; 95% CI: 1.23-2.78; letter+leaflet: OR: 3.18; 95% CI: 2.12-4.76). People who considered screening to be ineffective (OR: 0.12; 95% CI: 0.08-0.19), those who considered it to be effective but reported even moderate levels of anxiety (OR: 0.32; 95% CI: 0.23-0.45), and those who mentioned previous knowledge of CRC screening tests were less likely to accept the invitation (OR: 0.49; 95% CI: 0.34-0.70). CONCLUSIONS: Adoption of health protective behaviors is associated with a higher attendance rate, whereas anxiety represents a strong barrier, even among people who deemed screening to be effective. Increasing the proportion of people who consult their GP when making a decision regarding screening might enhance participation.

Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening.

BACKGROUND & AIMS: We conducted a study to estimate population coverage and detection rate (DR) achievable through different strategies of colorectal cancer (CRC) screening. METHODS: A population-based multicenter randomized trial comparing 3 strategies was used: (1) biennial immunologic fecal occult blood test (FIT), (2) "once only" sigmoidoscopy (FS), and (3) "once only" colonoscopy (TC). A random sample of men and women, aged 55 to 64 years, was drawn from general practitioners' (GP) rosters. Eligible subjects, randomized within GP, were mailed a personal invitation. Nonresponders in groups 2 and 3 were invited again at 12 and 24 months. Screenees with "high-risk" distal polyps (villous component >20%, high-grade dysplasia, CRC, size >or=10 mm, >2 adenomas) at FS, or with positive FIT, were referred for TC. RESULTS: The attendance rate was 32.3% (1965/6075) for FIT, 32.3% (1944/6018) for FS, 26.5% (1597/6021) for TC. FIT detected 2 patients with CRC (0.1%) and 21 with an advanced adenoma (1.1%). The corresponding figures were as follows: 12 (0.6%) and 86 (4.5%) patients, respectively, for FS; 13 (0.8%) and 100 (6.3%) patients, respectively, for TC. To detect 1 advanced neoplasm, it would be necessary to invite 264 people with FIT, 60 with FS, 53 with TC. FS would have detected 27.3% of the proximal advanced neoplasms detected at TC. Assuming the same participation rate at TC as at FS, 48 TCs would be necessary to detect 1 additional advanced neoplasm missed by FS. CONCLUSIONS: When participants are offered 1 screening test, participation is lower in a TC than in an FS program. However, DR of advanced neoplasia is higher with TC.

History of negative colorectal endoscopy and risk of rectosigmoid neoplasms at screening flexible sigmoidoscopy.

BACKGROUND AND AIMS: Screening sigmoidoscopy can reduce incidence of colorectal cancer and mortality. The optimal re-screening interval has not yet been defined. This study is aimed at estimating the risk of distal advanced adenomas (diameter >/=10 mm, villous component >20%, high-grade dysplasia) and cancer at screening flexible sigmoidoscopy in subjects aged 55-64 years who reported pre-screening negative colorectal endoscopy. PATIENTS: Eight thousands two hundred two subjects aged 55-64 years who underwent screening flexible sigmoidoscopy within the SCORE trial in Italy and who were able to report their previous history of colorectal endoscopy. RESULTS: Eight hundred eighty three of 8,202 subjects (10.8%) reported at least one prescreening negative endoscopy: among them, after 3-5 years, 6-10 years and >10 years intervals between last reported examination and screening endoscopy, the Absolute Risk of advanced adenomas was 1.5%, 0.9% and 0.9%; one cancer was detected (0.1%). Among the 7,319 subjects who did not report prescreening endoscopy the risks of advanced adenoma and cancer were 3.2% and 0.4%, respectively. Subjects with a previous colorectal examination had a 65% decreased risk of advanced adenomas (OR=0.35, 95%CI 0.18-0.66) and a 71% decreased risk of cancer (OR=0.29, 95%CI 0.04-1.12) as compared to those who did not. For subjects without family history of colorectal cancer the statistically significant decrease of the risk persisted up to ten years. The observed benefit seems not to apply to subjects with family history of colorectal cancer. CONCLUSIONS: Our results are consistent with the hypothesis that the interval between screening sigmoidoscopies could be safely expanded beyond 5 years for subjects without specific risk factors for colorectal cancer.

Randomized trial of different screening strategies for colorectal cancer: patient response and detection rates.

BACKGROUND: Although there is general consensus concerning the efficacy of colorectal cancer screening, there is a lack of agreement about which routine screening strategy should be adopted. We compared the participation and detection rates achievable through different strategies of colorectal cancer screening. METHODS: From November 1999 through June 2001 we conducted a multicenter, randomized trial in Italy among a sample of 55-64 year olds in the general population who had an average risk of colorectal cancer. People with previous colorectal cancer, adenomas, inflammatory bowel disease, a recent (< or =2 years) colorectal endoscopy or fecal occult blood test (FOBT), or two first-degree relatives with colorectal cancer were excluded. Eligible subjects were randomly assigned, within the roster of their general practitioner, to 1) biennial FOBT (delivered by mail), 2) biennial FOBT (delivered by general practitioner or a screening facility), 3) patient's choice of FOBT or "once-only" sigmoidoscopy, 4) "once-only" sigmoidoscopy, or 5) sigmoidoscopy followed by biennial FOBT. An immunologic FOBT was used. Participation and detection rates of the strategies tested were compared using multivariable logistic regression models that adjusted for age, sex, and screening center. All statistical tests were two-sided. RESULTS: Of 28 319 people sampled, 1637 were excluded and 26 682 were randomly assigned to a screening arm. After excluding undelivered letters (n = 427), the participation rates for groups 1, 2, 3, 4, and 5 were 30.1% (682/2266), 28.1% (1654/5893), 27.1% (970/3579), 28.1% (1026/3650), and 28.1% (3049/10 867), respectively. Of the 2858 subjects screened by FOBT, 122 (4.3%) had a positive test result, 10 (3.5 per 1000) had colorectal cancer, and 39 (1.4%) had an advanced adenoma. Among the 4466 subjects screened by sigmoidoscopy, 341 (7.6%) were referred for colonoscopy, 18 (4 per 1000) had colorectal cancer, and 229 (5.1%) harbored an advanced adenoma. CONCLUSIONS: The participation rates were similar for sigmoidoscopy and FOBT. The detection rate for advanced neoplasia was three times higher following screening by sigmoidoscopy than by FOBT.

Predicting proximal advanced neoplasms at screening sigmoidoscopy.

PURPOSE: This study was designed to assess the predictive value for advanced proximal neoplasms (cancer, adenoma > or = 10 mm, or villous component > 20 percent, or severe dysplasia) of the characteristics of distal polyps. METHODS: The study was conducted among patients, aged 55 to 64 years, referred for colonoscopy in the Italian trial of sigmoidoscopy screening for colorectal cancer. Patients reporting a history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy, or two first-degree relatives with colorectal cancer were excluded. We compared the prevalence of advanced proximal neoplasia in patients with "low-risk" (1-2 tubular adenomas, < 10 mm, with low-grade dysplasia, or hyperplastic polyp) and in those with "high-risk" (size, > or = 10 mm, or > or = 3 adenomas, or villous component > 20 percent, or severe dysplasia) polyps in the distal colon. RESULTS: Of 426 patients with polyps > 5 mm, 29 (6.9 percent) were detected with an advanced proximal neoplasm (including 4 colorectal cancers). The prevalence of proximal advanced neoplasia was 9.4 percent among patients with high-risk distal polyps and 2.5 percent among those with low-risk lesions (adjusted odds ratio, 3.19; 95 percent confidence interval, 1.06-9.59). Approximately 40 people with low-risk distal polyps 6 to 9 mm should undergo colonoscopy to detect one proximal advanced neoplasm; the corresponding number for patients with high-risk distal polyps is 10. CONCLUSIONS: The 2.5 percent prevalence of proximal advanced neoplasms among people with low-risk 6-mm to 9-mm distal polyps is similar to the prevalence observed among people without distal polyps. Restricting colonoscopy referral to patients with high-risk distal polyps might represent a cost-effective strategy in a screening context.

Baseline findings of the Italian multicenter randomized controlled trial of "once-only sigmoidoscopy"--SCORE.

BACKGROUND: A single sigmoidoscopy examination at around age 60 years has been proposed as a cost-effective strategy to prevent colorectal cancer. A multicenter randomized controlled trial, the SCORE trial, is in progress in Italy to estimate the impact of this strategy on colorectal cancer incidence and mortality and the duration of the protective effect. We present the baseline screening outcomes. METHODS: A questionnaire was mailed to a random sample of 236 568 people aged 55-64 years to assess their eligibility for and interest in screening. Those reporting a history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy, or two first-degree relatives with colorectal cancer were excluded. Eligible, interested respondents were assigned randomly to the control group (no further contact) or the intervention group (invitation to undergo sigmoidoscopy). Screenees with colorectal cancer, polyps larger than 5 mm, three or more adenomas, adenomas 5 mm or smaller with a villous component of more than 20%, or severe dysplasia were referred for colonoscopy. RESULTS: Of the 56 532 respondents (23.9% of those invited), 34 292 were enrolled and 17 148 were assigned to the screening group. Of those, 9999 attended and 9911 were actually examined by sigmoidoscopy. Distal adenomas were detected in 1070 subjects (10.8%). Proximal adenomas were detected in 116 of 747 (15.5%) subjects without cancer at sigmoidoscopy who then underwent colonoscopy. A total of 54 subjects was found to have colorectal cancer, a rate of 5.4 per 1000 (54% of which were Dukes' A). The procedures were relatively safe, with two perforations (one in 9911 sigmoidoscopy exams and one in 775 colonoscopies) and one hemorrhage requiring hospitalization after polypectomy during colonoscopy. The pain associated with sigmoidoscopy was described as mild or less than expected by 83.3% of the screenees. CONCLUSION: Sigmoidoscopy screening is generally acceptable to recipients and safe. The high yield of advanced adenomas is consistent with the projected impact of sigmoidoscopy screening on colorectal cancer incidence.