Abstracts intubation of the cecum. The placebo group received saline. Operators were blinded to the intervention. Information regarding indication, preparation, sedation, colonoscope type, times of insertion/withdrawal, depth of colonoscope insertion, polyp morphology, size and location, perceived difficulty of colonoscopy and failure were recorded.Results: 310 patients (mean age 60, 52% female) were enrolled prior to the conduction of this analysis, completion of 620 patients is expected by April 2010. There was failure to intubate the cecum in 5 (1.6%) cases (4 obstructing tumours, 1 poor preparation). 148 patients were randomised to receive hyoscine butylbromide and 157 to placebo. There were no significant differences between the intervention and placebo groups in age, gender, indication, colonoscope type, insertion time, perceived difficulty of colonoscopy or preparation. The number of polyps detected per patient did not differ significantly between the hyoscine and placebo groups (1.20 ⫾ 1.70 vs 0.99 ⫾ 1.48; p ⫽ 0.26). The number of polyps per patient with polyps did not differ significantly betwen the hyoscine and placebo groups (2.25 ⫾ 1.75 vs 2.05 ⫾ 1.54; p ⫽ 0.48). Presence or absence of polyps did not vary with the intervention (p ⫽ 0.48; Chi squared test).Predictors of polyp detection identified by multivariate logistic regression were increased withdrawal time and age. Polyp size did not vary between the placebo and intervention groups. There were no complications.Conclusion: Interim analysis of this randomised controlled trial indicates that hyoscine butylbromide is unlikely to aid in polyp detection. Predictors of polyp detection in this trial were age and withdrawal time.
683a Impact of a CT Colonography Colorectal Cancer Screening Program on Optical Colonoscopy: 5 Year Data Mark E. Benson, Jeff Pier, Sally Kraft, David H. Kim, Perry J. Pickhardt, Deepak V. Gopal, Mark Reichelderfer, Kevin Dasher, Patrick Pfau Introduction: The effect of CT Colonography (CTC), or Virtual Colonoscopy (VC), on Optical Colonoscopy (OC), has been a topic of speculation, with prior modeling studies suggesting a significant reduction in the numbers of OC exams performed as a consequence of CTC screening. In 2004, the University of Wisconsin became the first institution in the United States to have third party payer coverage of CTC for average risk colorectal cancer (CRC) screening.Aim: To determine the effect, over a 5 year period, of a CTC screening program on the number of screening, therapeutic and total OC exams performed.Methods: We examined the mean numbers of screening, therapeutic and total OC exams performed, per quarter (3 months), in patients, age 50-75, in 2003 as compared to 2008 (before and 5 years after the initiation of open access insurer covered CTC). Results: The CTC screening program began in 2004 with a peak number of 307 CTC exams performed in the 3rd quarter of 2005, declining to 203 CTC exams performed in the last quarter of 2008. Screening OC exams increased significantly from 555 mean per quarter in 2003 to 995 mean per quarter performed in 2008 (P ⬍ 0.001). The mean per quarter number of total OC exams in patients 50-75 years old performed increased significantly from 1104 in 2003 to 1976 in 2008 (P ⬍ 0.001). The mean number of per quarter therapeutic colonoscopies remained constant from 463 in 2003 to 490 in 2009 (P ⫽ 0.36). The number of total colon CRC screening exams (OC ⫹ CTC) increased significantly from 555 per quarter in 2003 to 1187 in 2008 (P ⬍ 0.001). In the year 2009, 5 years after initiation of a CTC screening program, a mean of 1255 quarterly screening exams were performed with 86.6 % of the patients screened with optical colonoscopy and 8.5 % screened with CT colonography.Conclusions: 1) Since the initiation of third party covered CTC screening at our institution, the overall number of total CRC screening exams (CTC ⫹ OC) has greatly increased. 2) Furthermore, the initiation of a CTC screening program did not lead to a reduction in the number of OC exams performed, conversely, a significant increase in the number of screening and total OC exams completed was observed. 3) Five years after the initiation of a CTC CRC screening program, OC remains the predominant screening modality for colorectal cancer.
683b Long Term Cancer-Free Survival Is Similar With Either Endoscopic or Surgical Treatment of Malignant Colo-Rectal Polyps - Report of an Analysis of the Surveillance, Epidemiology, and End Results Database Saowanee Ngamruengphong, Michael D. Crowell, Ananya Das Background:Malignant colorectal polyps (MCP) are commonly encountered in clinical practice. Although these polyps can be managed by endoscopic therapy when feasible, long-term outcome of endoscopic therapy compared to surgical treatment remains unknown. The outcomes evaluated were cancer-specific mortality in patients with MCP managed with endoscopic therapy compared to surgical resection.Methods:The Surveillance, Epidemiology, and End Results database of the National Cancer Institute was searched to identify patients 50 years or older who were diagnosed with stage 0 or stage 1 colorectal cancer by modified AJCC criteria between 1998 - 2006. The association between types of treatment received (endoscopic vs. surgical resection) and cancer-specific
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mortality were analyzed using Kaplan-Meier survival estimates and Cox proportional hazards models controlling for patient and tumor specific factors.Results:Of 4,817 MCP patients identified, 3378 (70%) were managed surgically and 1,439 (30%) endoscopically, Overall cancer-specific mortality was 2.9%. The length of follow-up was longer for endoscopically managed compared with surgically resected pts (37 ⫹ 27 mos vs 20 ⫹ 17 mos) Endoscopic management was more likely in patients with multiple, villous MCP of the rectum that were 2 cm or less in size with no submucosal involvement. Surgical resection was more likely for MCP of the right colon. The relative hazard (RH) for colorectal cancer specific mortality in the endoscopy group was not statistically different than that in surgical group (RH, 1.22; 95% CI, 0.81-1.83, p⫽0.31); estimated 5 yr survival rate 92⫹2% and 94⫹1%, respectively. Significant explanatory variables included older age at diagnosis (more than 65 years old; RH, 2.28; 95% CI, 1.49-3.48, p⬍0.001), more than one primary cancer (compared to one primary only; RH, 1.93, 95% CI, 1.31-2.83, p⫽0.01), and tumor size ⬎ 2 cm in size (compared to ⱕ 2 cm; RH, 1.59, 95% CI, 1.12-2.27, p⫽0.009). Conclusions:5 year survival is similar with either endoscopic or surgical treatment Malignant colorectal polyps
683c Adenoma Detection Rate During Screening Colonoscopy Increases With Each Decade of Life Over 50 Sarah Diamond, Maneesh Gupta, Jennifer L. Holub, David A. Lieberman, Glenn M. Eisen Background: Adenoma detection rate (ADR) is a quality indicator for colonoscopy as determined by ASGE and ACG guidelines. Based on current guidelines, endoscopists are expected to identify adenomas in ⬎ 25% of asymptomatic men and ⬎15% of asymptomatic women over 50 years of age. To further define the role of age and gender in expected rates, we reviewed the results of a large clinical database of screening colonoscopies. Methods: The Clinical Outcomes Research Initiative (CORI) database was queried to review screening colonoscopy results during the study period (2005-2006). Results from 15,550 patients (8217 men) who underwent screening colonoscopy were examined. Pathology was reviewed in those individuals who underwent polypectomy. Adenomatous polyps were classified as follows: tubular adenoma, tubulovillous adenoma and serrated adenoma. More advanced lesions were also identified including carcinoma in situ, high grade dysplasia and adenocarcinoma. The rate of adenoma detection was calculated based on gender and decade of life after 50. Results: 46.0% of study subjects underwent polypectomy. 61.1% of polyps were adenomas or more advanced lesions. Table l shows an increase in adenoma detection rate by decade of life. Detection rates in male subjects exceeded those in females in all age ranges evaluated. Conclusions: ADR increases in both men and women with each decade of life over 50. Physician case- mix adjustment should be considered when developing benchmarks for ADR as a quality indicator. Table 1 MEN AGE
ADR
WOMEN 95% CI
ADR
⬍50 23.6% 20.2, 27.1 14.5% 50-59 30.4% 28.9, 31.8 18.6% 60-69 37.5% 35.5, 39.4 24.9% 70-79 40.8% 37.9, 43.8 31.0% 80⫹ 51.3% 44.4, 58.4 29.5% ADR⫽ adenoma detection rate, CI⫽ confidence interval
95% CI 11.5, 17.4 17.3, 19.9 23.1, 26.9 28.1, 33.9 23.3, 35.6
683d Associations of Polyp and Endoscopic Mucosal Resection (EMR) Characteristics With Presence of Residual Disease on First Follow-up Endoscopy Timothy A. Woodward, Patrick W. Cleveland, Silvio W. De Melo, Massimo Raimondo, Michael G. Heckman, Nancy Diehl, Michael B. Wallace Background: EMR is an endoscopic technique developed for removal of sessile neoplasms confined to superficial layers of the GI tract. Determinants as to what factors predict residual disease at endoscopy, for both colonic and extracolonic EMRs, are based on relatively small series in the U.S. The primary aim of this study is to evaluate potential risk factors for presence of residual disease on first follow-up endoscopy, separately in colonic, esophageal, and duodenal EMRs.Methods: The following information was collected from EMRs on 883 polyps (607 colonic, 165 esophageal, 72 duodenal, 39 stomach) in 621 patients (421 colonic, 117 esophageal, 58 duodenal, 29 stomach) in this retrospective study: age, sex, ASA class, polyp site, prior EMR, endoscopist, prior biopsy, polyp size, polyp morphology, injection fluid, lifting sign, EMR method, supplemental methods, prophylactic clips, specimen, and presence of residual
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Abstracts disease on first follow-up endoscopy. Differences in the proportion of EMRs with residual disease at first follow-up endoscopy between colonic, esophageal, and duodenal EMRs were assessed using Fisher’s exact test. For colonic and esophageal EMRs, multivariable logistic regression models were used to examine associations while accounting for potentially confounding relationships between variables. Results: Residual disease at first follow-up endoscopy was present for 68 of 607 colonic EMRs (11.2%, 95% CI: 8.8% - 14.0%), 27 of 165 esophageal EMRs (16.3%, 95% CI: 11.1% - 22.9%), and 13 of 72 duodenal EMRs (18.1%, 95% CI: 10.0% - 28.9%). For colonic EMRs, there was evidence of an increased rate of residual disease for larger polyps (ⱕ2 cm: 9% vs. ⬎2 cm: 16%, P⫽0.010), polyps without a lifting sign (25% vs. 10%, P⫽0.009), polyps removed using the piecemeal method (17% vs. 6%, P⬍0.001), and although not statistically significant, polyps with a prior biopsy (16% vs. 10%, P⫽0.067). The piecemeal method was also associated with an increased rate of residual disease on first follow-up endoscopy for both esophageal (28% vs. 11%, P⫽0.013) and duodenal (28% vs. 6%, P⫽0.024) EMRs.Conclusion: This study provides evidence that residual disease on first follow-up endoscopy occurs more often when the piece-meal method is used in colonic EMRs. This association was independent of other variables considered. A similar association was observed in esophageal EMRs, though it did not quite retain statistical significance after multiple testing adjustments. Noted also, for colonic EMRs, was a trend towards increased rate of residual disease for larger polyps and polyps without a lifting sign.
683e Nurse Endoscopists Performing Colonoscopy: A Prospective Study on Quality and Patient Experiences Paul G. Van Putten, Frank Ter Borg, Rob Adang, Monique E. Van Leerdam, Ernst J. Kuipers Background: There is increasing interest and growing demand for nurses to perform colonoscopy. This is, among other factors, driven by the increased endoscopic demand resulting from colorectal cancer screening programs. Nurse endoscopists (NE) have shown to be competent and safe in gastroscopy and sigmoidoscopy. However, to date little is known about the performance of NE in colonoscopy. Aim: To assess endoscopic quality and patient experiences of NE performing full colonoscopy. Methods: Five trained NE were enrolled in a multicenter prospective study. 100 consecutive colonoscopies of each NE were evaluated for endoscopic quality and patient experiences. The colonoscopies were performed under supervision of a senior gastroenterologist, using techniques and protocols of the participating hospitals. Patient experiences were measured using a questionnaire. Descriptive statistics were used to report the data.Results: Five NE; all women, median age 47 years (range 36-49), median number of performed colonoscopies before the start of the study 550 (range 2602000). In total 500 colonoscopies were evaluated in 500 patients; mean age 55 years (SD ⫾15), 61% women, and 98% ASA I or II. 97% of patients received conscious sedation with midazolam. Colonoscopies were performed for screening or surveillance in 39%, and for symptomatic indications in 61% of patients. The un-assisted cecal intubation rate was 92%, mean cecal intubation time was 15 minutes (SD ⫾9), and mean withdrawal time was 10 minutes (SD ⫾3). Adenoma detection rate was 24.8%. In 154 out of 500 procedures (31%) the NE required assistance for an advice, or help with a polypectomy or loop. Complication rate was 0.2%; one perforation. 363/500 patients (73%) completed the questionnaire. Overall, 345/363 patients (95%) were satisfied with the endoscopic procedure. 243/363 (67%) experienced no pain during the procedure, whereas 99/363 (27%) experienced moderate and 20/363 (6%) experienced substantial pain. Respondents were satisfied with the communicative and technical skills of the nurse endoscopists in 358/363 (99%) and 343/363 (95%) of cases, respectively. 259/363 respondents (71%) had no specific preference for a physician or nurse endoscopist, whereas 56/363 (15%) preferred a physician endoscopist and 48/363 (13%) preferred a nurse endoscopist. Considering colonoscopy waiting time for a NE and hereafter for a physician endoscopist to be 2 weeks shorter, 246/363 (68%) and 234/363 (65%) of respondent preferred the colonoscopy at a shorter time interval.Conclusion: Nurse endoscopists perform colonoscopies according to the international recognized quality standards, with high patient satisfaction.
683f Early Repeat Colonoscopy Within 5 Years After a Normal Screening Colonoscopy in Medicare Patients Amanpal Singh, Nischita K. Reddy, Yong Fang Kuo, Gottumukkala S. Raju, James S. Goodwin INTRODUCTION & AIM: The guidelines for colon cancer screening from the gastroenterology societies and USPSTF recommend repeat screening colonoscopy in 5-10 years for patients with normal colonoscopy. The aim of our study is to estimate the utilization of colonoscopy earlier than 5 years in patients (pts) with normal baseline colonoscopy in Medicare patients.METHODS: A 5%
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random national sample of Medicare pts aged ⱖ 66 years who underwent a complete colonoscopy during 2001-2003 and who did not have history of inflammatory bowel disease, colorectal cancer or resection of colon or rectum from a year before to 3 months after the baseline colonoscopy were included. The study cohort was followed until the pts had a repeat colonoscopy, death, lost Medicare Part A or B coverage, switched to HMO or end of study period (12/31/2006). Definitions: Normal baseline colonoscopy was classified as one if there was no biopsy or polyp related procedure during colonoscopy. Early repeat colonoscopy (ERC) was defined as one which was done during 3-59 months after the normal baseline colonoscopy. We examined indications for ERC, whether it was done for screening or for specific indications like anemia, occult or overt gastrointestinal bleeding, weight loss or abdominal pain in the 3 months prior to the repeat colonoscopy. A multivariate model was constructed to estimate the impact of various factors on the rate of ERC. RESULTS: A total of 89,660 pts (60% female and 92.5% White) had a normal baseline colonoscopy. Early repeat colonoscopy was undertaken in 28.7% pts (see Table). The median duration between the two colonoscopies was 35 months.Reasons for ERC: The rate of asymptomatic ERC was 15.3 % within five years (47.9% of all ERC). Factors influencing ERC: A. Demographics: Female gender, White race & residence in the New England area were independent predictors associated with lower rate of ERC. B. Type of practice: Patients who had baseline colonoscopy in an office (HR 1.4 (95% CI 1.28-1.53)) and by a Non-gastroenterologist (HR 1.09 (95% CI 1.02-1.17) for a general physician and 1.16 (95% CI 1.1-1.22) for surgeons) were more likely to get an ERC. CONCLUSIONS: Our study shows that colonoscopy is over-utilized in the Medicare patients especially for those undergoing early repeat colonoscopy without preceding symptoms. If the resources are reallocated, more patients can undergo screening colonoscopy without increased expenditure.
Rate of Early Repeat Colonoscopy Repeat colonoscopy
1 year
2 years
3 years
4 years
59 months
All patients Asymptomatic patients
1.7% 0.7%
5.7% 2.4%
12.5% 5.7%
20.8% 10.6%
28.7% 15.3%
683g EUS-FNA Detection of Micrometastases and Survival of Resected Early Stage Lung Cancer Michael B. Wallace, Carolyn E. Reed, Brenda J. Hoffman, Gerard A. Silvestri, Elizabeth Garrett-Mayer, Robert H. Hawes, Massimo Raimondo, Timothy A. Woodward, John A. Odell Background: Non-small cell lung cancer (NSCLC) is the most common cancerrelated cause of death the United States and EUS plays an important role in mediastinal lymph node (MLN) staging. Only 30-50% of resected, MLNnegative patients survive long term; indicating the presence of micrometastases. EUS-FNA combined with real time PCR detects molecular evidence of micrometastases in approximately 19% of pathologically negative MLN. In this study, we assess whether the presence of micrometastases by EUS-FNA confers an increased risk of disease recurrence. Methods: Patients with potentially resectable NSCLC underwent EUS-FNA sampling of MLN for cytology and PCR of a predetermined marker set (EPCAM/Lunx). All patients who completed R0 resection, mediastinal negative (AJCC Stage 1 or 2) were included. PCR was performed using standard methods from EUS-FNA specimens as previously reported by our group (Mitas et al. Clin Chem 2003). Results: 150 patients with proven lung cancer completed EUS-FNA of mediastinal lymph nodes. 97 were excluded due to grossly malignant MLN at EUS or surgery, other histologic types (e.g. carcinoid), unfit to complete surgery or un-evaluable RNA (2) leaving 53 patients in the final analysis. Of these 53 patients, 22 (42% [95% CI:31-53]) had at least one mediastinal lymph nodes that met previously establish marker thresholds consistent with micrometastases. Patients who had MLN with PCR evidence of micrometastases had significantly worse survival than those who did not. (Figure 1). Conclusion: EUS-FNA with PCR can identify evidence of micrometastases in MLN of NSCLC patients and these patients have worse survival than those without. Further study is now needed to determine if these higher risk patients may benefit from pre-operative chemoradiotherapy similar to those patients with standard pathological evidence of mediastinal lymph node metastases.
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