Background Endoscopic submucosal dissection (ESD) was recently developed to allow en bloc resection of early neoplasia of the GI tract, including colorectal neoplasia. The endoscopic technique is ...technically demanding and not yet standardized, and new devices are needed. Objective This study aimed to evaluate the efficacy and safety of a new device that combines the functions of injection and cutting. Design Prospective, pilot, single-arm study. Methods Consecutive patients with rectal laterally spreading tumors (LSTs) 3 cm or larger unsuitable for en bloc resection were enrolled. ESD was performed with a new device that allows cutting and coagulation as well as a needleless, tissue-selective mucosal and submucosal elevation through an axial water-jet channel. Main Outcome Measurement The primary endpoint of the study was the en bloc resection rate achieved with ESD in a Western hospital setting. Results Overall, ESD was attempted in 40 consecutive patients (27 male, mean age 65.3 years) with rectal LSTs larger than 3 cm (72.5% LSTs, nongranular type, 5% depressed type, 22.5% protruding type). The mean lesion size was 46.8 ± 10.9 mm (range 33-80 mm). The mean procedure time was 86.1 ± 35.5 minutes (range 40-190 minutes). The en bloc resection rate was 90% (36/40). In the remaining patients, resection was completed with a piecemeal approach. The rate of curative resection (R0) was 32 of 40 LSTs (80%). Two patients with submucosal invasion were referred for surgery. Perforation occurred in 1 patient (2.5%), which was managed conservatively. Postoperative bleeding occurred in 2 patients (5%) and was treated by endoscopic hemostasis. Limitations Single-center study with a relatively small number of patients. Conclusions ESD is a safe and effective method to provide en bloc and curative resection of large rectal LSTs. The operating time and adverse event rate were comparable to those of previously published data from Japanese experts.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background In vivo prediction of colorectal polyp histology by narrow-band imaging (NBI) could potentially avoid post-polypectomy histologic examination or resection of diminutive lesions, thereby ...reducing costs and risk. Objective To assess whether NBI is able to predict colonoscopy surveillance intervals and histology of distal diminutive polyps according to American Society for Gastrointestinal Endoscopy (ASGE) criteria. Design Prospective, multicenter study. Setting Five endoscopic centers. Patients Consecutive patients undergoing colonoscopy in 5 centers were included. Intervention Participating endoscopists were required to pass a before-study qualifying examination. Histology of polyps that were <10 mm was predicted at NBI and assigned a designation of high or low confidence. Main Outcome Measurements Accuracy of high-confidence NBI prediction for polyps ≤5 mm in predicting surveillance intervals and negative predictive value (NPV) for adenomatous histology in the rectosigmoid colon were compared with the ASGE thresholds (90% agreement, 90% NPV). Results A total of 278 patients (mean age, 63 years; 58% male) were enrolled. At colonoscopy, 574 (97.3%) polyps <10 mm (429 ≤5 mm, 60% adenomatous) were retrieved for histologic analysis. Sensitivity, specificity, positive and negative predictive values, and accuracy of high confidence-NBI predictions for adenomatous histology in lesions ≤5 mm were 90%, 88%, 89%, 89%, and 89%, respectively. High-confidence characterization of polyps ≤5 mm predicted the correct surveillance interval in 92% to 99% of cases, according to the American and European guidelines. NPV of high-confidence NBI for adenomatous histology for the rectosigmoid colon lesions ≤5 mm was 92%. Limitations Only experienced endoscopists were included. Conclusion High-confidence prediction of histology for polyps ≤5 mm appears to be sufficiently accurate to avoid post-polypectomy histologic examination of the resected lesions as well as to allow rectosigmoid hyperplastic polyps to be left in place without resection. (Clinical trial registration number: NCT01675752 .)
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background and Aims The Narrow-band Imaging International Colorectal Endoscopic (NICE) Classification has been validated for differentiating hyperplastic from adenomatous polyps. This classification ...system was based on narrow-band imaging (NBI) technology, leaving uncertainty regarding its applicability to other systems. The aim of this study was to assess accuracy and reliability of histologic predictions for polyps <1 cm by applying the NICE classification to the Fujinon Spectral Imaging Color Enhancement (FICE) System. Methods A video library of 55 polyps <1 cm histologically verified with FICE was prospectively created, including polyps that fulfilled inclusion criteria (morphology, size, histology) in consecutive colonoscopies. Six endoscopists with experience in electronic chromoendoscopy independently reviewed the polyp images, scored the polyps as adenomatous or hyperplastic, and assigned a level of confidence to the predictions. Twenty videos were reassessed at 6 months. The diagnostic performances of the endoscopists was calculated both combined and individually according to the histopathology of the polyps. A mixed-effect logistic regression model, in which polyps were considered as random effects, and polyp histology, confidence level, and readers were considered as fixed effects, was used. Results were expressed as odds ratios (ORs) with 95% confidence intervals (CIs). Results Of the 55 polyps (mean size 4.6 mm), 29 (53%) were adenomas, and 26 (47%) were hyperplastic. Across all the readers and observations, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the curve (AUC) were 77%, 75%, 88%, 75%, 77%, and 0.82, respectively. Individual rater accuracy ranged from 66% to 96%, being <90% in 5 of 6 cases. Overall, 68.5% of predictions (226/330) were made with high confidence, although there was high variability (Fleiss kappa, 0.15; 95% CI, 0.08-0.22). Sensitivity, specificity, PPV, NPV, accuracy, and AUC for predictions made with high confidence were 81%, 80.5%, 80%, 77%, 82%, and 0.88 being significantly more accurate as compared with a low confidence of diagnosis (OR 2.4; 95% CI, 1.2-4.7). Regarding the performance of the individual NICE criteria, the odds of adenoma detection were 3.4 (95% CI, 1.8-6.3) and 4.0 (95% CI, 2.1-7.5) by using surface and vessels patterns alone, as compared with the color criterion. Interrater and intrarater agreement with the NICE was only moderate (interrater: Fleiss kappa, 0.51; 95% CI, 0.44-0.56; intrarater: kappa, 0.40; 95% CI, 0.20-0.60). Conclusions The application of the NICE classification to FICE resulted in suboptimal accuracy and only moderate interobserver agreement.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background and Aims Submucosal injection is currently used in GI endoscopy to reduce resection risks and to perform submucosal dissection; it is usually performed via an injection needle or a ...needleless device. The aim of the study was to compare 2 submucosal injection modalities (needle-assisted vs needleless) by using substances with different viscosities Methods Needle and needleless injections were compared by assessing the efficacy of tissue elevation with 5 different substances in an ex vivo porcine model. The height of the submucosal elevation was measured 0(t0), 10(t1), and 30 minutes after injection (t2). Viscosity of the solution was also measured. Results For both stomach and rectum, at t0, t1, and t2 no difference in the height of the elevation was found between the needle and needleless technique, irrespective of the substance. Tissue elevation in the stomach was similar between the 2 techniques at t0 (9.9 ± 1.58 vs 9.4 ± 1.3 mm, P = .3), t1 (7.2 ± 1.56 vs 6.9 ± 1.4 mm, P =. 26), and t2 (6 ± 1.6 vs 5.5 ± 1.3 mm, P = .18). No difference was found in the rectum at t1 and t2, whereas a slightly higher elevation with the needle-assisted technique was observed at t0 (t0: 12.4 ± 1.3 vs 11.2 ± 1.6 mm, P = .003; t1: 8.7 ± 1.3 vs 8.3 ± 1.5 mm; P = .32; t2: 7.0 ± 1.4 vs 7.2 ± .76 mm; P = .75). When comparing the substances with normal saline solution, more viscous solutions showed a significantly higher elevation at t0, t1, and t2 irrespective of the injection modalities and the location. Conclusions No differences were found in the height of submucosal injection or in the persistence of such elevation when comparing needleless with needle-assisted injection, with the only minor exception of the initial elevation in the rectum, which does not appear to be clinically relevant. Viscous solutions resulted in higher and more persistent elevations as compared with normal saline solution.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK