Akiko Ono

Colonoscopy versus Fecal Immunochemical Testing in Colorectal-Cancer Screening

BACKGROUND Colonoscopy and fecal immunochemical testing (FIT) are accepted strategies for colorectal-cancer screening in the average-risk population. METHODS In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, we compared one-time colonoscopy in 26,703 subjects with FIT every 2 years in 26,599 subjects. The primary outcome was the rate of death from colorectal cancer at 10 years. This interim report describes rates of participation, diagnostic findings, and occurrence of major complications at completion of the baseline screening. Study outcomes were analyzed in both intention-to-screen and as-screened populations. RESULTS The rate of participation was higher in the FIT group than in the colonoscopy group (34.2% vs. 24.6%, P<0.001). Colorectal cancer was found in 30 subjects (0.1%) in the colonoscopy group and 33 subjects (0.1%) in the FIT group (odds ratio, 0.99; 95% confidence interval [CI], 0.61 to 1.64; P=0.99). Advanced adenomas were detected in 514 subjects (1.9%) in the colonoscopy group and 231 subjects (0.9%) in the FIT group (odds ratio, 2.30; 95% CI, 1.97 to 2.69; P<0.001), and nonadvanced adenomas were detected in 1109 subjects (4.2%) in the colonoscopy group and 119 subjects (0.4%) in the FIT group (odds ratio, 9.80; 95% CI, 8.10 to 11.85; P<0.001). CONCLUSIONS Subjects in the FIT group were more likely to participate in screening than were those in the colonoscopy group. On the baseline screening examination, the numbers of subjects in whom colorectal cancer was detected were similar in the two study groups, but more adenomas were identified in the colonoscopy group. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT00906997.).

Efficacy of the Invasive/Non-invasive Pattern by Magnifying Chromoendoscopy to Estimate the Depth of Invasion of Early Colorectal Neoplasms

OBJECTIVE: During colonoscopy, estimation of the depth of invasion in early colorectal lesions is crucial for an adequate therapeutic management and for such task, magnifying chromoendoscopy (MCE) has been proposed as the best in vivo method. However, validation in large-scale studies is lacking. The aim of this prospective study was to clarify the effectiveness of MCE in the diagnosis of the depth of invasion of early colorectal neoplasms in a large series.METHODS: A total of 4,215 neoplastic lesions were evaluated using MCE from October 1998 to September 2005 at the National Cancer Center Hospital, Tokyo, Japan. Lesions were prospectively classified according to the clinical classification of the pit pattern: invasive pattern or non-invasive pattern. All lesions were histopathologically evaluated.RESULTS: There were 3,371 adenomas, 612 intramucosal cancers (m-ca), 232 submucosal cancers (sm-ca): 52 sm superficial (sm1) and 180 sm deep cancers (sm 2–3). Among lesions diagnosed as invasive pattern, 154 out of 178 (86.5%) were sm2–3, while among lesions diagnosed as non-invasive pattern, 4,011 out of 4,037 (99.4%) were adenomas, m-ca, or sm1. Sensitivity, specificity and diagnostic accuracy of the invasive pattern to differentiate m-ca or sm1 (<1000 μm) from sm2–3 (≥1000 μm) were 85.6%, 99.4%, and 98.8%, respectively.CONCLUSION: The determination of invasive or non-invasive pattern by MCE is a highly effective in vivo method to predict the depth of invasion of colorectal neoplasms.

Endoscopic submucosal resection with a ligation device is an effective and safe treatment for carcinoid tumors in the lower rectum.

Background and Aims:  Various methods for complete endoscopic resection of rectal carcinoid tumors have been reported; however, the number of cases investigated in each study has been limited. The aim of the present study was to clarify the clinical usefulness of a novel technique named endoscopic submucosal resection with a ligation device (ESMR‐L) in a large number of rectal carcinoid tumors.

Modifiable endoscopic factors that influence the adenoma detection rate in colorectal cancer screening colonoscopies

BACKGROUND Adenoma detection rate (ADR) has become the most important quality indicator for colonoscopy. OBJECTIVE The aim of this study was to investigate which modifiable factors, directly related to the endoscopic procedure, influenced the ADR in screening colonoscopies. DESIGN Observational, nested study. SETTING Multicenter, randomized, controlled trials. PATIENTS Asymptomatic people aged 50 to 69 years were eligible for a multicenter, randomized, controlled trial designed to compare colonoscopy and fecal immunochemical testing in colorectal cancer screening. A total of 4539 individuals undergoing a direct screening colonoscopy were included in this study. INTERVENTION Colonoscopy. MAIN OUTCOME MEASUREMENTS Bowel cleansing, sedation, withdrawal time in normal colonoscopies, and cecal intubation were analyzed as possible predictors of adenoma detection by using logistic regression analysis, adjusted for age and sex. RESULTS In multivariate analysis, after adjustment for age and sex, factors independently related to the ADR were a mean withdrawal time longer than 8 minutes (odds ratio [OR] 1.51; 95% CI, 1.17-1.96) in normal colonoscopies and split preparation (OR 1.26; 95% CI, 1.01-1.57). For advanced adenomas, only withdrawal time maintained statistical significance in the multivariate analysis. For proximal adenomas, withdrawal time and cecal intubation maintained independent statistical significance, whereas only withdrawal time longer than 8 minutes and a <10-hour period between the end of preparation and colonoscopy showed independent associations for distal adenomas. LIMITATIONS Only endoscopic variables have been analyzed. CONCLUSION Withdrawal time was the only modifiable factor related to the ADR in colorectal cancer screening colonoscopies associated with an increased detection rate of overall, advanced, proximal, and distal adenomas.

Colorectal endoscopic submucosal dissection: Technical advantages compared to endoscopic mucosal resection and minimally invasive surgery

In recent years, the effectiveness of colorectal endoscopic submucosal dissection (ESD) has been increasingly reported. Herein, we highlight the most recent developments and technical advantages of colorectal ESD compared to EMR and minimally invasive surgery.

Achieving the best bowel preparation for colonoscopy

Bowel preparation is a core issue in colonoscopy, as it is closely related to the quality of the procedure. Patients often find that bowel preparation is the most unpleasant part of the examination. It is widely accepted that the quality of cleansing must be excellent to facilitate detecting neoplastic lesions. In spite of its importance and potential implications, until recently, bowel preparation has not been the subject of much study. The most commonly used agents are high-volume polyethylene glycol (PEG) electrolyte solution and sodium phosphate. There has been some confusion, even in published meta-analyses, regarding which of the two agents provides better cleansing. It is clear now that both PEG and sodium phosphate are effective when administered with proper timing. Consequently, the timing of administration is recognized as one of the central factors to the quality of cleansing. The bowel preparation agent should be administered, at least in part, a few hours in advance of the colonoscopy. Several low volume agents are available, and either new or modified schedules with PEG that usually improve tolerance. Certain adjuvants can also be used to reduce the volume of PEG, or to improve the efficacy of other agents. Other factors apart from the choice of agent can improve the quality of bowel cleansing. For instance, the effect of diet before colonoscopy has not been completely clarified, but an exclusively liquid diet is probably not required, and a low-fiber diet may be preferable because it improves patient satisfaction and the quality of the procedure. Some patients, such as diabetics and persons with heart or kidney disease, require modified procedures and certain precautions. Bowel preparation for pediatric patients is also reviewed here. In such cases, PEG remains the most commonly used agent. As detecting neoplasia is not the main objective with these patients, less intensive preparation may suffice. Special considerations must be made for patients with inflammatory bowel disease, including safety and diagnostic issues, so that the most adequate agent is chosen. Identifying neoplasia is one of the main objectives of colonoscopy with these patients, and the target lesions are often almost invisible with white light endoscopy. Therefore excellent quality preparation is required to find these lesions and to apply advanced methods such as chromoendoscopy. Bowel preparation for patients with lower gastrointestinal bleeding represents a challenge, and the strategies available are also reviewed here.

Evaluation of the effects of combination therapy with branched-chain amino acid and zinc supplements on nitrogen metabolism in liver cirrhosis

Aim:  Disorders of protein metabolism in liver cirrhosis can affect prognosis or cause complications. Treatment with branched‐chain amino acid (BCAA) and zinc supplements has been shown to be effective against abnormal nitrogen metabolism in liver cirrhosis. There are, however, few studies on the effects of combining these supplements. In this study, the effect of combining BCAA and zinc treatment in cirrhosis was investigated.

Risk of Advanced Proximal Neoplasms According to Distal Colorectal Findings: Comparison of Sigmoidoscopy-Based Strategies

BACKGROUND Screening for colorectal cancer with sigmoidoscopy benefits from the fact that distal findings predict the risk of advanced proximal neoplasms (APNs). This study was aimed at comparing the existing strategies of postsigmoidoscopy referral to colonoscopy in terms of accuracy and resources needed. METHODS Asymptomatic individuals aged 50-69 years were eligible for a randomized controlled trial designed to compare colonoscopy and fecal immunochemical test. Sigmoidoscopy yield was estimated from results obtained in the colonoscopy arm according to three sets of criteria of colonoscopy referral (from those proposed in the UK Flexible Sigmoidoscopy, Screening for COlon REctum [SCORE], and Norwegian Colorectal Cancer Prevention [NORCCAP] trials). Advanced neoplasm detection rate, sensitivity, specificity, and number of individuals needed to refer for colonoscopy to detect one APN were calculated. Logistic regression analysis was performed to identify distal findings associated with APN. All statistical tests were two-sided. RESULTS APN was found in 255 of 5059 (5.0%) individuals. Fulfillment of UK (6.2%), SCORE (12.0%), and NORCCAP (17.9%) criteria varied statistically significantly (P < .001). The NORCCAP strategy obtained the highest sensitivity for APN detection (36.9%), and the UK approach reached the highest specificity (94.6%). The number of individuals needed to refer for colonoscopy to detect one APN was 6 (95% confidence interval [CI] = 4 to 7), 8 (95% CI = 6 to 9), and 10 (95% CI = 8 to 12) when the UK, SCORE, and NORCCAP criteria were used, respectively. The logistic regression analysis identified distal adenoma ≥10 mm (odds ratio = 3.77; 95% CI = 2.52 to 5.65) as the strongest independent predictor of APN. CONCLUSIONS Whereas the NORCCAP criteria achieved the highest sensitivity for APN detection, the UK recommendations benefited from the lowest number of individuals needed to refer for colonoscopy.

Prospective controlled study on the effects of polyethylene glycol in capsule endoscopy.

AIM To prospectively confirm whether a small amount of polyethylene glycol (PEG) ingested after swallowing endoscopy capsule improves image quality and completion rate. METHODS Forty-four consecutive patients referred to us for capsule endoscopy (CE) were randomized to two groups. All patients were restricted to clear fluids for 12 h before the examination. Patients in group A (22 cases) received no additional preparation, while those in group B (20 cases) ingested 500 mL of PEG within a 2 h period starting 30 min after swallowing the capsule. Clear fluids and meals were allowed 2 h and 4 h after capsule ingestion, respectively. Image quality was assessed as the percentage of visualized bowel surface area as follows: 1: < 25%; 2: 25%-49%; 3: 50%-74%; 4: 75%-89%; 5: > 90%. The small bowel record was divided into five segments by time, and the score for each segment was evaluated. All CE examinations were performed with the Pillcam SB capsule endoscopy system (Given Imaging Co. Ltd., Yoqnem). RESULTS This study ended in December 2009, because sample size was considered large enough. A total of 44 patients were enrolled. Two patients in group B were excluded from the analysis because small bowel images could not be obtained from these patients; one had a full stomach, while the other presented with a massive gastric bleed. Thus, 22 patients from group A and 20 patients from group B completed the study. There was no significant difference in age (P = 0.22), sex (P = 0.31), and indication for CE. No significant adverse events occurred in any of the study patients. In group A, image quality deteriorated as the capsule progressed distally. However, in group B, image quality was maintained to the distal small bowel. In each of the five segments, the visibility score was significantly higher in group B than in group A (segment 1: 4.3 ± 0.7 vs 4.7 ± 0.5, P = 0.03; segment 2: 4.2 ± 0.9 vs 4.8 ± 0.4, P = 0.01; segment 3: 4.0 ± 1.0 vs 4.6 ± 0.7, P = 0.04; segment 4: 3.6 ± 1.1 vs 4.5 ± 0.6, P = 0.003; segment 5: 2.7 ± 1.0 vs 4.4 ± 0.8, P = 0.00004). Thus, the use of PEG during CE examination significantly improved image quality in all time segments, and this effect was more pronounced in the distal ileum. The completion rate to the cecum was not significantly different between groups A and B (81.8% vs 85.0%, P = 0.89). There was no difference in the gastric transit time between groups (36.2 ± 35.0 min vs 54.0 ± 56.6 min, P = 0.23), but the small bowel transit time was significantly longer in group A than in group B (246.0 ± 107.0 min vs 171.0 ± 104.0 min, P = 0.04). CONCLUSION The ingestion of a small amount of PEG after the swallowing of an endoscopy capsule significantly improved CE image quality, but did not enhance the completion rate to the cecum.

Colonoscopy quality assessment

AIM Colonoscopy has become accepted as the most effective method for colon exploration. Some application problems have been detected in the setting of normal clinical care due to its wide range of uses in recent years, and therefore there is a need to measure colonoscopy quality. For that purpose valid quality indicators are necessary to be defined. The application process of some quality indicators is presented in this study. The proposed indicators in this study are: quality of bowel preparation, cecal intubation rate, withdrawal time, adenoma detection rate, and adenoma removal rate. MATERIAL AND METHOD This is a prospective 12-month study where colonoscopies performed in the VI health area of Murcia Region were evaluated. From February 2006 to February 2007 a total of 609 subjects were eligible for colonoscopy after a positive fecal blood test in the setting of a colorectal cancer screening program. A sample of thirty patients (n: 30) was considered representative to assess the reliability of quality indicators and for a preliminary analysis of results. RESULTS Indicators results are: quality of bowel preparation (87%), kappa 0.74 (95% CI: 0.48-0.99); cecal intubation rate (90%) 0.74 (95% CI: 0.49-0.99); adenoma detection and removal rate (96%), kappa: 0.78 (95% CI: 0.53-0.99); withdrawal time: 13.36 min (95% CI: 10.48-16.11). Kappa: 0.78 (95% CI: 0.49-0.99). CONCLUSIONS Quality indicators definition and application in colonoscopy performance is possible. More studies are necessary to define the role of these indicators in the setting of clinical practice.