Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study).

OBJECTIVE: Colon capsule endoscopy (CCE) has shown promise for colorectal neoplasia detection compared with optical colonoscopy (OC), but has not been compared with other screening tests in average risk screening patients. DESIGN: Patients 50 to 75 years of age (African Americans, 45-75 years) were randomised to CCE or CT colonography (CTC) and subsequent blinded OC. The primary endpoint was diagnostic yield of polyps ≥6 mm with CCE or CTC. Secondary endpoints included accuracy for size and histology, examination completeness, number/proportion of subjects with polyps and adenomas ≥6 mm and ≥10 mm, subject satisfaction and safety. RESULTS: From 320 enrolled subjects, data from 286 (89.4%) were evaluable. The proportion of subjects with any polyp ≥6 mm confirmed by OC was 31.6% for CCE versus 8.6% for CTC (pPr non-inferiority and superiority=0.999). The diagnostic yield of polyps ≥10 mm was 13.5% with CCE versus 6.3% with CTC (pPr non-inferiority=0.9954). The sensitivity and specificity of CCE for polyps ≥6 mm was 79.2% and 96.3% while that of CTC was 26.8% and 98.9%. The sensitivity and specificity of CCE for polyps ≥10 mm was 85.7% and 98.2% compared with 50% and 99.1% for CTC. Both tests were well tolerated/safe. CONCLUSION: CCE was superior to CTC for detection of polyps ≥6 mm and non-inferior for identification of polyps ≥10 mm. CCE should be considered comparable or superior to CTC as a colorectal neoplasia screening test, although neither test is as effective as OC. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov no: NCT02754661.

Utility of video capsule endoscopy for longitudinal monitoring of Crohn's disease activity in the small bowel: a prospective study.

BACKGROUND AND AIMS: This prospective, multicenter study evaluated small-bowel capsule endoscopy (CE) for the longitudinal assessment of mucosal inflammation in subjects with Crohn's disease (CD). METHODS: Subjects with known CD underwent clinical evaluation with ileocolonoscopy and CE at baseline and 6-month follow-up. Small-bowel patency was confirmed before CE at both time points. The Simple Endoscopic Score for CD (SES-CD) was used for ileocolonoscopy, and the Lewis score and the CE CD Endoscopic Index of Severity (CECDEIS) were used for CE. Clinical scoring indices included the Physician Global Assessment (PGA), CD Activity Index (CDAI), and Harvey-Bradshaw Index (HBI). Laboratory markers including C-reactive protein, fecal calprotectin, and erythrocyte sedimentation rate were collected at baseline and follow-up. Correlation between endoscopic scores and clinical parameters were measured using Spearman tests. RESULTS: A total of 74 subjects were enrolled, of whom 53 (72%) completed endoscopic procedures at baseline and 6-month follow-up. The SES-CD ileocolonoscopy score correlated with the Lewis score (P < .001, ρ = .59) and CECDEIS capsule score (P = .002, ρ = .48). None of the 3 endoscopic scores correlated with PGA, CDAI, HBI, C-reactive protein, erythrocyte sedimentation rate, or fecal calprotectin. Approximately 85% of subjects had proximal small-bowel inflammation identified on CE. There were no CE-related adverse events. CONCLUSIONS: There was high correlation between CE and ileocolonoscopy scores for the assessment of mucosal disease activity over time; however, there were no correlations between endoscopic scores and clinical parameters. The use of serial CE for the assessment of small-bowel CD is feasible and valid. (Clinical trial registration number: NCT01942720.).

European experience with methotrexate treatment in Crohn's disease: a multicenter retrospective analysis.

INTRODUCTION: Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for decades. Nevertheless, current data provide equivocal evidence on the efficacy of MTX in CD.The aims of this study were to describe the efficacy of MTX for maintenance of remission in CD and to identify the factors associated with the probability of steroid-free clinical remission in a multicenter European referral center cohort. PATIENTS AND METHODS: This was a retrospective cohort analysis. Consecutive patients treated with MTX for CD were included from 11 referral centers. Patients receiving concomitant treatment with tumor necrosis factor inhibitors or thiopurines were excluded. The main outcome was steroid-free clinical remission; the secondary outcomes included the rate of complications leading to MTX discontinuation and duration of relapse-free survival in patients achieving the main outcome. RESULTS: Between July 1992 and January 2012, 118 patients were identified for inclusion. MTX administration route was oral for induction in 31.4% and for maintenance in 49.1% of the patients. Steroid-free remission was achieved in 44/118 (37.2%) patients and was maintained relapse free by 28/44 (63.6%) for a median of 12 (3.5-18.5) months. At least one adverse effect was reported by 28.9% of the patients. No clinical or demographic factors were associated with either likelihood of achieving a clinical response or duration of relapse-free survival. CONCLUSION: MTX treatment induced steroid-free clinical remission in over a third of CD patients and maintained it for a year in almost two-thirds of the responders. MTX should be considered a viable therapeutic option in CD patients refractory to other therapies.

Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population.

BACKGROUND & AIMS: Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population. METHODS: In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. RESULTS: Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%-84%) and 93% specificity (95% CI, 91%-95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%-86%) and 97% specificity (95% CI, 96%-98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%-93) and 82% specificity (95% CI, 80%-83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%-97%) and 95% specificity (95% CI, 94%-95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses. CONCLUSIONS: In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.

Comparison of procedural sequence in same-day consecutive bidirectional endoscopy using moderate sedation: a prospective randomized study.

BACKGROUND: A sequential bidirectional endoscopy is commonly performed. However, the optimal sequence of procedures for same-day bidirectional endoscopy using moderate sedation has not been established. GOALS: The aim of this study was to characterize the optimal sequence of endoscopies for sequential bidirectional endoscopy. STUDY: This was a single-center, prospective, randomized study. A total of 163 patients aged 18 to 80 years, who were referred for bidirectional endoscopy for any indication, were randomized to start with upper or lower endoscopy. Initially, all patients received intravenously 50 mg of meperidine and 2.5 mg of midazolam. Patient's discomfort and satisfaction, as expressed by the amount of analgesia added to sustain conscious sedation, and the postprocedure satisfaction reported by the patients were set as primary outcomes. RESULTS: There was no significant difference in the total dose of midazolam added, patient's pain assessment and satisfaction from the anesthesia and the procedure, duration of endoscopies, or the time to cecal intubation between the esophagogastroduodenoscopy first and colonoscopy first groups. The rate of diagnosis of significant pathologies and the rate of procedures performed during the examinations were similar in both the study groups. Evaluation of patient's postprocedural recovery did not reveal significant differences. There was no significant variance between the performing physicians regarding anesthetic dosing, duration of examination, pain scoring, and the related patient's pain postprocedural assessment. CONCLUSIONS: There were no significant differences in the patient's discomfort and satisfaction, regardless of the procedural sequence.

Idiopathic liver function test abnormality in pregnancy is associated with assisted reproduction techniques.

OBJECTIVE: To examine the prevalence, etiology, risk factors, and outcomes of liver abnormality in pregnancy, in a tertiary medical center, and to study the potential impact of artificial reproduction techniques (ART) on the incidence and the outcome of pregnancy-related liver abnormality. DESIGN: A retrospective case-control study using an electronic database and patients' files. SETTING: Tertiary referral center. PATIENT(S): Women in the third trimester of pregnancy who were hospitalized for delivery. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Development of significant elevation of alanine aminotransferase (ALT ≥ 100 IU/L). Secondary outcomes included development of maternal and fetal complications. RESULT(S): The upper limit of normal of ALT was ≥ 1.5 times and it occurred in 440 (1.6%) pregnancies; of those, 228 (0.8%) had ALT ≥ 100 IU/L. The etiology of significant liver test abnormality was idiopathic in 47% of patients. Compared with spontaneous pregnancies (295/23,793), ART was significantly associated with liver test abnormality (145/4, 520). The presence of ALT ≥ 100 IU/L in the third trimester was associated with higher rates of cesarean sections, prematurity, low birthweight, and fetal complications. CONCLUSION(S): A definite etiology was not determined in about half of pregnancy-associated liver test abnormality. The ART was significantly associated with liver test elevation. Significant liver test abnormality in the third trimester may have an impact on maternal and fetal/neonatal outcomes.

Head or tail: the orientation of the small bowel capsule endoscope movement in the small bowel.

BACKGROUND AND AIMS: The diagnostic accuracy of capsule endoscopy has been suggested to be influenced by the direction of the passage in the intestine. It is currently unknown if a head-first or a tail-first orientation are equally common during the descent through the small bowel. The aim of the study was to identify the orientation of the capsule along the migration through the small bowel. METHODS: Thirty capsule endoscopies were reviewed by an experienced observer. The direction of the passage through the pylorus and the ileoceccal valve was recorded for all the examinations. In addition, detailed review of the passage of the capsule in different segments of the small bowel was undertaken for all the capsules. RESULTS: The capsule was significantly more likely to pass the pylorus head-first compared to tail-first (25 and 5 out of 30, respectively, OR 5, 95% CI 65-94%, P < 0.001). In 28/30 studies, the capsule exited the ileoceccal valve head-first (OR-14, 95% CI 77-99%, P < 0.001). In an immersion experiment, uneven distribution of weight of the capsule body was demonstrated with the head part (camera tip) being lighter than the tail part. CONCLUSIONS: The capsule endoscope usually passes through the pylorus and subsequent segments of the small bowel head-first. This observation suggests that the intestinal peristaltic physiology drives symmetrical bodies with their light part first. The principle of intestinal orientation by weight distribution may bear implications for capsules' design in the future.

Quality of life after breast cancer surgery with or without reconstruction.

In the modern era, where breast-conserving surgery is a viable alternative to mastectomy, breast cancer patients and their healthcare providers have to consider the issue of quality of life in regards to the type of surgery. The choice of surgical procedure should consider the perceptions of women diagnosed with breast cancer as well as their functional and emotional well-being. A more holistic approach to the patient should be implemented with proper psychological evaluation before and psychological support after the crisis.