Diagnostic and therapeutic single-operator cholangiopancreatoscopy with SpyGlassDS™: results of a multicenter retrospective cohort study.

BACKGROUND AND AIMS: The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™. METHODS: In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months. RESULTS: Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001). CONCLUSIONS: SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.

New flexible endoscopic controlled stapler technique for the treatment of Zenker's diverticulum: A case series.

AIM: To report about the combination and advantages of a stapler-assisted diverticulotomy performed by flexible endoscopy. METHODS: From November 2014 till December 2015 17 patients (8 female, 9 male, average age 69.8 years) with a symptomatic Zenker diverticulum (mean size 3.5 cm) were treated by inserting a new 5 mm fully rotatable surgical stapler (MicroCutter30 Xchange, Cardica Inc.) next to an ultrathin flexible endoscope through an overtube. The Patients were under conscious sedation with the head reclined in left position, the stapler placed centrally and pushed forward to the bottom of the diverticulum. The septum was divided by the staple rows under flexible endoscopic control. RESULTS: In eleven patients (64.7%) the stapler successfully divided the septum completely. Mean procedure time was 21 min, medium size of the septum was 2.8 cm (range 1.5 cm to 4 cm). In four patients the septum was shorter than 3 cm, in seven longer than 3 cm. To divide the septum, averagely 1.3 stapler cartridges were used. Two minor bleedings occurred. Major adverse events like perforation or secondary haemorrhage did not occur. After an average time of two days patients were discharged from the hospital. In 6 patients (35.3%) the stapler failed due to a thick septum or insufficient reclination of the head. Follow up endoscopy was performed after an average of two months in 9 patients; 4 patients (44.4%) were free of symptoms, 5 patients (55.6%) stated an improvement. A relapse of symptoms did not occur. CONCLUSION: Flexible endoscopic Zenker diverticulotomy by using a surgical stapler is a new, safe and efficient treatment modality. A simultaneously tissue opening and occlusion prevents major complications.

EndoClot Polysaccharide Hemostatic System in Nonvariceal Gastrointestinal Bleeding: Results of a Prospective Multicenter Observational Pilot Study.

BACKGROUND AND STUDY AIMS: Hemostatic powders have been introduced to improve the management of gastrointestinal (GI) bleeding and to extend the variety of tools available for emergency endoscopy. The aim of the present pilot study was to evaluate the indication profiles and the short-term outcome of EndoClot. PATIENTS, MATERIALS AND METHODS: In a prospective observational pilot study patients with acute nonvariceal GI bleeding were included. Primary or secondary application of EndoClot was assessed. Hemoglobin, prothrombine time and platelets were documented before and after hemostasis. The efficacy of EndoClot was assessed 72 hours and 1 week after application. RESULTS: Seventy patients with acute GI bleeding were recruited into the study. Eighty-three percent (58/70) of the patients had upper and 17% (12/70) had lower GI bleeding. In the upper GI tract treatment success was achieved in 64% (30/47, 95% confidence interval, 50%-76%) after primary use and in all patients, when used after established techniques had failed (95% confidence interval, 70%-100%). In lower GI bleeding hemostasis was achieved in 83% of cases (10/12, 95% confidence interval 54%-97%). Rebleeding occurred in 11% (8/70), in 10% EndoClot served as a bridge to surgery (7/70). CONCLUSIONS: EndoClot expanded the therapeutic options in the management of GI bleeding. It was applicable as a monotherapy or in combination with other techniques from oozing bleeding type or lower. It was most effective in diffuse or extensive bleeding activity or when access to the bleeding vessel was difficult. EndoClot can be applied as a bridge to surgery when classical methods of hemostasis have failed.

Narrow-band imaging vs. high definition white light for optical diagnosis of small colorectal polyps: a randomized multicenter trial.

BACKGROUND AND STUDY AIM: The aim of the study was to compare the latest narrow-band imaging (NBI) device with high-definition white light (HDWL) endoscopy for accuracy of real-time optical diagnosis of small colorectal polyps. PATIENTS AND METHODS: We conducted a randomized, prospective, multicenter trial at three study sites in Germany. In the NBI arm, endoscopists used NBI for the prediction of polyp pathology on the basis of the NBI International Colorectal Endoscopic classification. In the HDWL arm, NBI was not used for optical classification of polyp histology. The primary outcome was accuracy of optical diagnoses (neoplastic vs. non-neoplastic) in small polyps measuring < 10 mm. Secondary end points included sensitivity and negative predictive value (NPV). RESULTS: A total of 380 patients were randomized 1:1 to either the NBI or HDWL arm. A total of 421 polyps measuring < 10 mm were detected (55.8 % neoplastic, 44.2 % non-neoplastic). Accuracy, sensitivity, and NPV were 73.7 %, 82.4 %, and 75.5 %, respectively, in the NBI arm and 79.2 %, 79.8 %, and 73.4 %, respectively, in the HDWL arm (P = 0.225, P = 0.667, P = 0.765). More polyps were assessed with high confidence in the HDWL arm (82.6 %) than in the NBI arm (73.7 %; P = 0.038). The NPV of the prediction of neoplastic histology in diminutive polyps (≤ 5 mm) rated with high confidence was 90.3 % in the NBI arm. We detected significant differences between the participating study sites in the performance data of predictions. CONCLUSION: The levels of accuracy for real-time prediction of polyp histology (< 10 mm) did not differ between NBI and HDWL for optical diagnosis. Variation in the performance of optical diagnosis was apparent between study centers. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02009774).