Intraductal Biopsy Research Articles

Ultrasound-guided percutaneous biopsy for challenging perihilar focal liver lesions: diagnostic accuracy and safety assessment.

In cases of perihilar focal liver lesions, distinguishing between benign strictures and malignancies is critical to prevent unnecessary surgery. Although the use of contrast-enhanced CT or MRI in combination with clinical and laboratory findings can aid in diagnosis, histologic examination is often necessary. Histologic specimens can be obtained through various techniques, including ERCP-guided brush cytology or intraductal biopsy, cholangioscopy-directed biopsy or endoscopic ultrasound (EUS). However, these methods have been associated with suboptimal sensitivity and specificity, sometimes leading to inconclusive results. Therefore, ultrasound-guided percutaneous biopsy (US-guided PB) may play a crucial role, but data is lacking for perihilar lesions. The objective of our study was to assess the technical feasibility and safety of US-guided PB for perihilar lesions. We included 20 consecutive patients who underwent US-guided PB of perihilar liver lesions that were not suitable for surgery between June 2018 and October 2023. All samples were obtained using a Menghini needle 20G and were adequate for histological examination, with a mean diameter of 12.3 mm (range 3-40 mm). Out of the 20 patients, 11 were diagnosed with malignancy while the remaining 9 had inflammatory or fibrotic tissue samples. No adverse events related to the procedure were reported. US-guided PB of perihilar liver lesions is a valuable and safe diagnostic approach to consider for patients who are not suitable for surgery.

Diagnostic accuracy and interobserver agreement of cholangioscopy for indeterminate biliary strictures: A single-center experience

Background and study aimsCharacterization of indeterminate biliary strictures (IDBS) still represents a major challenge. Digital single-operator cholangioscopy (DSOC) could potentially overcome limits of conventional biopsy and brush sampling. The aim of this study was to compare diagnostic accuracy of visual evaluation and DSOC-guided biopsies to conventional trans-papillary sampling techniques and to evaluate the inter-observer agreement (IOA) on visual diagnosis. Patients and methodsAll consecutive patients undergoing DSOC-guided biopsy after conventional sampling techniques for IDBS during a six—year period were retrospectively evaluated. Final diagnosis was based on histological evaluation of the surgical specimen if available or a clinical follow-up of at least 6 months. For IOA, 20-second DSOC clips were retrospectively reviewed by 6 experts and 6 trainees and classified according to the Monaco Classification. ResultsThirty-five patients underwent DSOC for IDBS in the study period; 14 patients (F = 9) with a median age of 64 years (range 53–76) met the study aim. After DSOC, strictures location was changed in three patients (additional yield of 21.4 %). Intraductal DSOC-guided biopsy were technically successful in all cases, with an adequacy of 92.8 %. No adverse events were recorded. Final diagnosis was benign disease in five cases and cholangiocarcinoma in the others. For IOA, 29 videos were evaluated with almost perfect agreement for final diagnosis (kappa 0.871; agreement 93.1, p <0.001), although overall accuracy of DSOC visual finding was 73.6 % and 64.4 % for experts and trainees, respectively. ConclusionsDSOC could improve diagnostic accuracy for IDBS, since it showed high sensitivity for visual finding and high specificity for DSOC guided-biopsy. Visual diagnosis seems reliable for diagnosis using the Monaco Classification.

Clinical approach to indeterminate biliary strictures: Clinical presentation, diagnosis, and workup.

Despite advances in cross-sectional imaging and endoscopic technology, bile duct strictures remain a challenging clinical entity. It is crucial to make an early determination of benign or malignant nature of biliary strictures. Early diagnosis not only helps with further management but also minimizes mortality and morbidity associated with delayed diagnosis. Conventional imaging and endoscopic techniques, particularly endoscopic retrograde cholangiopancreatography (ERCP) and tissue sampling techniques play a key in establishing a diagnosis. Indeterminate biliary strictures (IDBSs) have no definite mass on imaging or absolute histopathological diagnosis and often warrant utilization of multiple diagnostics to ascertain an etiology. In this review, we discuss possible etiologies, clinical presentation, diagnosis, and management of IDBSs. Based on available data and expert opinion, we depict an evidence based diagnostic algorithm for management of IDBSs. Areas of focus include use of traditional tissue sampling techniques such as ERCP with brush cytology, intraductal biopsies, fluorescence in situ hybridization and flow cytometry. We also describe the role of endoscopic ultrasound (EUS)-guided fine needle aspiration and biopsies, cholangioscopy, confocal laser endomicroscopy, and intraductal EUS in management of IDBSs.

S367 Endoscopic Eversion and Stent-Assisted Strangulation for the Management of an Intraductal Papillary Neoplasm of the Bile Duct: A Minimally Invasive Technique for Non-Surgical Candidates

Introduction: Intraductal papillary neoplasms of the bile duct (IPNB) are uncommon lesions that may accompany risk for malignancy. Management is often surgical and may be associated with significant postoperative morbidity and mortality. Case Description/Methods: An 80-year-old female with a history of hepatocellular carcinoma (HCC) presented for management of jaundice and sepsis after microwave ablation of HCC. Computed tomography (CT) imaging demonstrated intra and extrahepatic biliary ductal dilation with a 19 mm soft tissue density in the distal common bile duct (CBD). Index labs depicted leukocytosis, hyperbilirubinemia, and elevated lactate. Endoscopic ultrasound (EUS) delineated a round, hypoechoic intraductal CBD lesion. The pancreas and ampulla were normal. Endoscopic retrograde cholangiopancreatography (ERCP) confirmed a distal CBD filling defect. Biliary sphincterotomy was performed and balloon sweeping revealed a frond-like partially protruding polypoid lesion suggestive of an IPNB. Due to non-surgical candidacy, we decided to perform a complete eversion with subsequent full prolapse of the lesion by using a biliary extraction balloon. This was followed by the placement of a biliary plastic stent to assist with strangulation of the base of the lesion. Biopsies were consistent with a papillary neoplasm with intestinal differentiation, confirming our findings of an IPNB, without accompanying high-grade dysplasia or carcinoma. Interval surveillance ERCP 3 months later revealed no protruding lesion from the major papilla, no residual filling defects on cholangiogram, and sweeping of the biliary tree uncovered no contents. Cholangioscopy demonstrated segmental mucosal irregularity with mild granular tissue in the mid/distal bile duct wall; however, cholangioscopy-guided intraductal biopsies and brushings showed benign reactive tissue and no recurrent IPNB. At 5 months of follow-up, the patient continues to do well. Discussion: IPNB is a rare biliary lesion. Radical surgical resection has been the mainstay of curative treatment. However, a few recent cases have described endoluminal radiofrequency ablation as an alternative therapy. To the best of our knowledge, this is the first reported case of balloon-assisted eversion combined with stent-assisted strangulation of an IPNB leading to spontaneous removal. In non-surgical candidates, this technique may be advantageous to minimize adverse operative outcomes, improve patient tolerance, and decrease cost. Watch the video at https://tinyurl.com/ACGAbstractS367

Antegrade endobiliary forceps biopsy under the optical coherence tomography control in the diagnosis of Klatskin tumor: preliminary results

Background: Transcutaneous transhepatic endobiliary forceps biopsy is an accepted method for verification of extrahepatic cholangiocarcinoma, but its sensitivity ranges from zero to 94%. In the recent years, optical coherence tomography (OCT) has been actively used to diagnose malignancies.&#x0D; Aim: To assess diagnostic accuracy of the OCT-assisted intraductal forceps biopsy in patients with Klatskin tumor.&#x0D; Materials and methods: From 2013 to 2021, 161 patients with preliminary diagnosis of Klatskin tumor were seen in Russian Scientific Center of Radiology and Surgical Technologies named after Academician A.M. Granov. The retrospective study included 48 patients and 51 procedures of the forceps biopsy. In 14 (29%) patients of the main study group, the biopsy procedure was performed with OCT assistance, whereas the control group (34 patients, 71%) had their biopsies without the OCT.&#x0D; Results: All procedures were technically successful. In the main and in the control study groups, sensitivity was 92.3% versus 73.3% (p = 0.32) and specificity 100% versus 85.7% (p = 0.88), respectively. Malignant neoplasm of the biliary tract was found in 13 cases versus 23 in the control group, with the degree of the tumor differentiation being determined in 64.3% (n = 9), versus 48.7% (n = 18) (p = 0.89), respectively. There were no adverse events associated with OCT and biopsy sampling in the main study group. In the control group, 4/37 procedures (10.8%) were associated with hemobilia, which was successfully treated conservatively within 24 hours without any prolongation of the hospital stay.&#x0D; Conclusion: Our preliminary results indicate that antegrade endobiliary forceps biopsy is a safe and informative technique. The OCT navigation increases the sensitivity and specificity of the diagnosis. This allows for a personalized choice of chemotherapy. OCT is a promising technique for differential diagnosis of Klatskin tumor from benign biliary strictures. Further large-scale studies are required to introduce it into everyday practice.

Endobiliary biopsy.

The differential diagnosis between benign and malignant biliary strictures is challenging and requires a multidisciplinary approach with the use of serum biomarkers, imaging techniques, and several modalities of endoscopic or percutaneous tissue sampling. The diagnosis of biliary strictures consists of laboratory markers, and invasive and non-invasive imaging examinations such as computed tomography (CT), contrast-enhanced magnetic resonance cholangiopancreatography, and endoscopic ultrasonography (EUS). Nevertheless, invasive imaging modalities combined with tissue sampling are usually required to confirm the diagnosis of suspected malignant biliary strictures, while pathological diagnosis is mandatory to decide the optimal therapeutic strategy. Although EUS-guided fine-needle aspiration biopsy is currently the standard procedure for tissue sampling of solid pancreatic mass lesions, its diagnostic value in intraductal infiltrating type of cholangiocarcinoma remains limited. Moreover, the “endobiliary approach” using novel slim biopsy forceps, transpapillary and percutaneous cholangioscopy, and intraductal ultrasound-guided biopsy, is gaining ground on traditional endoscopic retrograde cholangiopancreatography and percutaneous transhepatic cholangiography endobiliary forceps biopsy. This review focuses on the available endobiliary techniques currently used to perform biliary strictures biopsy, comparing the diagnostic performance of endoscopic and percutaneous approaches.

Usefulness of intraductal cholangioscopy biopsy forceps in critical strictures of the biliary anastomosis after liver transplantation.

Usefulness of intraductal cholangioscopy biopsy forceps in critical strictures of the biliary anastomosis after liver transplantation.

Feasibility of Narrow-Band Imaging, Intraductal Biopsy, and Laser Ablation During Mammary Ductoscopy: Protocol for an Interventional Study.

Introduction:Ductoscopy is a minimally invasive micro-endoscopic approach for direct visualization of intraductal lesions of the breast. Challenges of ductoscopy are low sensitivity for detecting malignancy, the lack of a proper intraductal biopsy device, and adequate treatment of intraductal lesions. This study will analyze three new approaches to enhance the effectiveness of interventional ductoscopy in patients with (premalignant) intraductal lesions: narrow-band imaging (NBI), new intraductal biopsy tools, and intraductal laser ablation. The main aims of the present study are to improve diagnostic accuracy and therapeutic efficacy of interventional ductoscopy in patients with pathological nipple discharge (PND) and to explore the feasibility of the new approaches in diagnosing and removing intraductal precursor lesions.Methods and analysis:This prospective, single-center, diagnostic feasibility study will include two patient groups. Group A: women with PND with no radiological suspicion for malignancy. Group B: women undergoing mastectomy (preventive or therapeutic). The primary endpoints for both groups are the technical feasibility of NBI ductoscopy, intraductal biopsy, and laser ablation, and as secondary endpoint the number of diagnosed and successfully treated intraductal lesions.Discussion:Enhanced ductoscopy with NBI, intraductal biopsy, and laser ablation could prevent unnecessary surgery in patients with PND.Ethics and dissemination:This study was approved by the Medical Research Ethics Committee UMC Utrecht in The Netherlands (METC protocol number 21-688/H-D). The results of this study will be published in peer-reviewed journals and presented at national and international conferences.Highlights:– Pathological nipple discharge (PND) is a common breast-related complaint in women.– Ductoscopy, a minimally invasive technique, is used in the treatment of PND.– This study will analyze three new approaches to enhance interventional ductoscopy of the breast: narrow-band imaging, new intraductal biopsy tools, and intraductal laser ablation in patients with (premalignant) intraductal lesions.

The Efficacy and Safety of Endoscopic Papillectomy Combined With Endobiliary Radiofrequency Ablation for Ampullary Neoplasms With Intraductal Biliary Extension

Background and aimsEndoscopic papillectomy is the preferred approach for management of ampullary adenomas. Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat malignant biliary strictures. The aim of this study was to evaluate the safety and efficacy of endoscopic papillectomy combined with endobiliary RFA for ampullary neoplasms with intraductal biliary extension. MethodsThis international multicenter retrospective study included patients with histologically proven ampullary neoplasms with intraductal biliary extension treated with endobiliary RFA. Descriptive statistics were used to characterize patient characteristics, endoscopic features, and recurrence. ResultsIn all, 8 patients (mean age: 75.9 ± 4.9 years; 5 males) were included in this study. EUS was performed in all cases prepapillectomy and the mean size of the lesion was 29.7 (SD 12.6) mm with a mean intraductal extension length of 14.4 (SD 4.2) mm. Histology consisted of adenocarcinoma in 5 patients (67.5%) and high-grade dysplasia in 3 patients (37.5%). A range of 1-3 RFA sessions was performed with biliary stent placement. For surveillance after completion of therapy, patients received a mean of 4.1 (SD 1.64) ERCPs with intraductal biopsy over a mean follow-up period of 28.5 (SD 10.4) months. Recurrence occurred in 2 (25%) patients at 14 and 20 months (both with adenocarcinoma initially), respectively (incidence rate of 15.8%/year). ConclusionEndoscopic papillectomy combined with intraductal RFA may be an effective and safe treatment for ampullary neoplasms with intraductal extension, particularly for patients who are poor surgical candidates. Given the risk of recurrence, indefinite surveillance is recommended.

Brush Cytology, Forceps Biopsy, or Endoscopic Ultrasound-Guided Sampling for Diagnosis of Bile Duct Cancer: A Meta-Analysis.

Endoscopic sampling is essential for tissue diagnosis of cholangiocarcinoma (CCA). To evaluate and compare the diagnostic sensitivities of endoscopic retrograde cholangiopancreatography-guided brush cytology biopsy, and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) in patients with CCA. A comprehensive literature search through multiple databases was conducted for articles published between January 1995 and August 2020. The pooled rates of sensitivity for the diagnosis of CCA and of adverse events were compared among brushing, biopsy, brushing & biopsy, and EUS-FNA. In total, 1123 patients with CCA (32 studies), 719 patients (20 studies), 358 patients (13 studies), and 422 patients (17 studies) were tested by brushing, biopsy, brushing & biopsy, and EUS-FNA, respectively. The pooled diagnostic sensitivity was 56.0% (95% confidence interval (CI) 48.8-63.1%, I2 = 83.0%) with brushing, 67.0% (95% CI 60.2-73.5%, I2 = 72.5%) with biopsy, 70.7% (95% CI 64.1-76.8%, I2 = 42.7%) with brushing & biopsy, and 73.6% (95% CI 64.7-81.5%, I2 = 74.7%) with EUS-FNA. The diagnostic sensitivity was significantly lower for brushing than for biopsy, brushing & biopsy, or EUS-FNA. No significant difference was noted in diagnostic sensitivities among biopsy, brushing & biopsy, and EUS-FNA. Adverse events were comparable between the groups. Intraductal biopsy, brushing & biopsy, and EUS-FNA had comparable efficacy and safety for the diagnosis of CCA. Brushing was the least sensitive diagnostic tool compared with intraductal biopsy or EUS-FNA. Given the modest diagnostic sensitivities of intraductal biopsy and EUS-FNA in the diagnosis of CCA, further studies for complementing these techniques with biomarkers may be needed.

Probe-based confocal laser endomicroscopy in the evaluation of dominant strictures in patients with primary sclerosing cholangitis: results of a U.S. multicenter prospective trial

Patients with primary sclerosing cholangitis (PSC) and dominant biliary strictures carry increased risk for the development of cholangiocarcinoma. Although ERCP-based techniques including brush cytology and intraductal biopsy sampling represent first-line tissue sampling methods for dominant strictures, sensitivity is low. Probe-based confocal laser endomicroscopy (pCLE) offers microscopic-level imaging of subepithelial biliary mucosa. Because data regarding the use of pCLE in PSC are limited, we aimed to investigate its diagnostic performance in dominant strictures. This was a multicenter prospective study involving PSC patients with dominant strictures. ERCP with pCLE was performed with use of the Miami classification (2+ criteria for malignant diagnosis) and Paris classification. Final malignant diagnoses required histopathologic confirmation, and benign diagnoses required a minimum of 1 year of follow-up without development of cancer. Fifty-nine patients (mean age, 49 years; 59% men) with 63 strictures were included in the study. Stricture locations included the common bile duct (31.7%), bifurcation (22.2%), and common hepatic duct (19%). Seven patients (11.9%) were found to have cholangiocarcinoma. The sensitivity and specificity of pCLE was 85.7% (95% confidence interval [CI], 42.1-99.6) and 73.1% (95% CI, 58.9-84.4), respectively. Within specific stricture locations, the highest sensitivity was seen at the bifurcation (100%; 95% CI, 2.5-100) and the right hepatic duct (100%; 95% CI, 29.2-100). The lowest sensitivities were seen at the common bile duct (25%; 95% CI, 5.5-57.2) and the left hepatic duct (28.6%; 95% CI, 3.7-70.9). In this prospective multicenter study, pCLE had a high sensitivity in detecting cholangiocarcinoma, but technical aspects of the probe may limit evaluation in the common bile duct and left hepatic duct. Further evaluation is needed to elucidate the role of pCLE in the algorithm of excluding neoplasia in biliary strictures associated with PSC. (Clinical trial registration number: NCT02736708.).

High sensitivity of ROSE-supported ERCP-guided brushing for biliary strictures.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) plays a major role in biliary strictures, with brushing being a cheap and fast method to acquire a cytological specimen, despite a sensitivity around 45 %. Rapid on-site evaluation (ROSE) is widely used for endoscopic ultrasound-acquired cytological specimen adequacy, improving its sensitivity and specificity. Nevertheless, no study has evaluated its role for ERCP-guided brushing. Our aim was to assess the diagnostic yield of ERCP-guided brushing of biliary strictures when supported by ROSE. Patients and methods This was a retrospective single-center study that included patients undergoing ERCP-guided brush cytology supported by ROSE for biliary strictures. Recorded data included patient clinical-radiological and ERCP features. Final diagnosis was determined after surgery, intraductal biopsy or adequate follow-up. The diagnostic yield was calculated and a subgroup analysis for factors associated with false-negative or true-positive results was performed. Results Two hundred six patients were included, 57.3 % males, median age 72 years, 77.2 % having extrahepatic biliary strictures. Of the patients, 99 % had an adequate sample at ROSE after a mean of 2.6 passages. The diagnostic yield was accuracy 83 %, sensitivity 74.6 %, and specificity 98 %, positive and negative predictive values 98 % and 71 % respectively, with an area under the curve of 0.86. A diagnosis of cholangiocarcinoma was significantly more frequent among true-positive cases (68 % vs 46.8 %; P = 0.04). Conclusions This is the first study evaluating the use of ROSE as support for ERCP-guided brushing of biliary strictures, with a sensitivity far higher than those reported for brushing alone and at least comparable to those of more expensive and invasive techniques.

Abstract PS3-15: Imaging of the distribution of human breast ducts

Abstract While most of the anatomy of the human body is well delineated and understood, the distribution of adult female breast ducts remains largely understudied despite the fact that breast cancer, is thought to start in the lining of a breast ductal lobular unit. These anatomical features develop from stem cells located behind the nipple under the influence of the hormones of puberty. The exact patterns and number of ducts in the normal female breast has received limited attention since the work of Astley Cooper in 1840 who admitted that he had artfully displayed the ducts in two dimensions for his book. Since then, Going et al has used computerized reconstruction to map one breast and investigators in Australia have used hand-held ultrasound on lactating women to gain some insight into the nipple anatomy. The descriptions of the number of ducts exiting the breast at the nipple can be divided into those who have cannulated ducts at the nipple (6-10) and those who enumerated the number of ducts seen on transection of the nipple. (15-20). Local anesthesia can be used as a nipple block allowing duct cannulation in women. Breast cancer starts in the lining of a milk duct which opens the way for the application of new diagnostic techniques such as liquid biopsy. The limitation of this approach, however, is the absence of an imaging modality to direct sampling. In collaboration with QT Imaging, images were obtained using non-invasive 3D Transmission Ultrasound (TU) imaging of whole in vivo breasts of three patients, a postmenopausal 64 year old woman, a woman with DCIS and one with an invasive cancer. TU is a novel FDA cleared imaging device utilizing 3D ultrasound data and modelling to yield speckle free sub-mm resolution quantitative estimates of tissue characteristics. The women were lying prone with their breast immersed in a water bath with reconstruction of the projection and reflected ultrasound data resulting in co-registered 3D reflection, speed-of-sound, and attenuation images. Machine learning at a voxel level was used to quantitively differentiate and segment breast tissues types based on reconstructed voxel tissue characteristics. These tissue types were then 3D printed into anatomical models representing a normal postmenopausal breast, one with DCIS and one with invasive cancer. The images demonstrated the distribution of ductal systems in two concentric groupings unrelated to quadrants. The DCIS and the invasive ductal cancer were limited to a single ductal system each. This new non-invasive technology enables precise localization of intraductal and invasive lesions. It opens up the potential for precise anatomic intraductal liquid biopsy for diagnosis as well as intraductal therapy. In addition, it has ramifications for better directing surgical removal of intraductal and invasive lesions. Citation Format: Susan M Love, James Klock, James Wiskin. Imaging of the distribution of human breast ducts [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS3-15.

Interobserver agreement in pathologic evaluation of bile duct biopsies

Intraductal biopsy is commonly used for preoperative evaluation of the etiology of biliary strictures. Interpretation of intraductal biopsies is frequently challenging. The diagnosis often suffers from interobserver disagreement, which has not been studied in the literature. We sought to assess interobserver concordance in the interpretation of intraductal biopsies. Eighty-five biopsies were retrieved, falling into five diagnostic categories: negative for dysplasia (NED), indefinite for dysplasia (IND), low-grade dysplasia (LGD), high-grade dysplasia (HGD), and carcinoma (CA). Eight gastrointestinal pathologists blindly reviewed all the slides. Agreement among pathologists was analyzed using Fleiss κ and weighted concordance coefficient S∗. A face-to-face consensus/training session was held to discuss the classification criteria, followed by a second round review. The overall interobserver agreement was fair in the first round review (κ=0.39; S∗=0.56) and improved to moderate in the second round review (κ=0.48; S∗=0.69). The agreement before and after consensus meeting was substantial to nearly perfect for CA (κ=0.65, S∗=0.83; and κ=0.80, S∗=0.91), fair for HGD (κ=0.28, S∗=0.69; and κ=0.40, S∗=0.63), and moderate for NED (κ=0.47, S∗=0.50; and κ=0.47, S∗=0.53). Agreement improved from fair to moderate for LGD (κ=0.36, S∗=0.61; and κ=0.49, S∗=0.71) and slight to fair for IND (κ=0.16, S∗=0.51; and κ=0.33, S∗=0.50). Compared with Hollande's fixed specimens, the agreement was higher in almost all diagnostic categories in formalin-fixed biopsies. Overall, interobserver concordance was improved after a consensus/training session. Interobserver reproducibility was high at the end of the diagnostic spectrum (CA) but fair to moderate for other diagnostic categories.

Possibilities of per-oral transpapillary cholangioscopy in oncological practice

Relevance. Diagnosis of malignant diseases causing bile duct strictures is a big challenge. At admission, patients with suspected biliary tract stricture, initially undergo endoscopic retrograde cholangiopancreatography (ERCP) as a diagnostic and treatment method. The morphological diagnosis of bile duct stricture based on ERCP with brush biopsy or intraductal forceps biopsy is limited by their low sensitivity. Consequently, a significant proportion of strictures remains undiagnosed, which led to the development of methods based on cholangioscopy.&#x0D; Aim. To determine the role of per-oral transpapillary cholangioscopy (TCS) in a specialized cancer clinic.&#x0D; Materials and methods. SpyGlass direct visualization system for per-oral intraductal examination from Boston Scientific was clinically tasted in Blokhin National Medical Research Center of Oncology of the Ministry of Health of Russia. Using this electronic system, TCS was performed in 4 patients with various malignant diseases.&#x0D; Results. In all cases, TCS was successful. In all patients, the diagnosis was confirmed with a forceps intraductal biopsy using Spybite forceps.&#x0D; Conclusion. Single-use electronic direct visualization system for per-oral intraductal examination and interventions like SpyGlass can be recommended for use in specialized cancer centers.

Combination of ERCP-Based Modalities Increases Diagnostic Yield for Biliary Strictures.

Biliary stricture evaluation with brush cytology and intraductal forceps biopsy carries a low sensitivity, but the combination of newer modalities may improve sensitivity. To determine whether the addition of advanced modalities increases diagnostic yield of ERCP-based sampling. This single-center retrospective study evaluates patients with biliary strictures sampled using brush cytology. Operating characteristics were calculated for individual and combinations of modalities including cholangioscopy, fluoroscopy- and cholangioscopy-directed intraductal biopsy, fluorescence in situ hybridization (FISH), and confocal laser endomicroscopy. Analyses under Standard Criteria (SC) included malignant results as "positive" and Expanded Criteria (EC) included "suspicious" and "high-grade dysplasia" results as "positive." A total of 614 patients were included, and 354 (57.8%) received brush cytology alone, which had a sensitivity of 38.5% (SC) to 40.3% (EC) and a specificity of 97.8% (EC) to 99.3% (SC). Combining brush cytology with fluoroscopy-guided biopsy (n = 259, 42.2%) had a sensitivity of 62.5% (SC) to 67.9% (EC) and specificity of 90.2% (EC) to 96.7% (SC). Adding FISH to brush cytology had a sensitivity of 84.2% (SC) to 87.5% (EC) and specificity of 54.1% (SC and EC), while cholangioscopy visualization addition resulted in a sensitivity of 80.4% (SC) to 92.2% (EC) and specificity of 67.3% (EC) to 89.1% (SC). There were no significant differences in sensitivity and specificity using SC and EC. Brush cytology has a low sensitivity, but the addition of other modalities increases sensitivity. There was no difference in specificity between the SC and the EC, supporting the inclusion of "suspicious" impressions with malignant resultsat our center.

Modern gastrointestinal endoscopic techniques for biliary tract cancers.

Biliary tract cancers, specifically cholangiocarcinomas (CCAs), arise from the epithelial cells of the biliary tree. They can be divided into three groups based on their location: intra-hepatic, peri-hilar or distal extra-hepatic CCAs. Traditionally, the main role of endoscopy in the management of biliary tract cancers was diagnosis and biliary decompression. For diagnosis, endoscopic retrograde cholangiopancreatography (ERCP) can be used to obtain either brushings or intra-ductal biopsies however both techniques have poor sensitivity. The introduction of cholangioscopy has allowed endoscopists to perform both targeted biopsies and also obtain a visual diagnosis. Similarly, with the spread of endoscopic ultrasound (EUS), the ability to obtain tissue by fine-needle aspiration is another avenue available, but concerns regarding tumor seeding still persist. For biliary decompression, with the advent of neo-adjuvant therapy, the role of early decompression is growing. Nevertheless, it is still not clear whether endoscopic decompression is superior to percutaneous decompression, especially in advanced hilar tumors. When possible, at least 50% of viable liver should be drained, and that will determine whether unilateral or bilateral stents are required. Additionally, there is growing evidence on the benefits of metal stents over plastic stents, but care should be taken as metal stents are generally permanent. Finally, although not widely available or adopted, with the growing use of radiofrequency ablation and the introduction of drug-eluting metal stents, the near-future might allow newer techniques to treat the disease itself.

Mixed-type intraductal papillary mucinous neoplasm in a patient with pancreas divisum: pancreatoscopy through the Santorini duct with direct intraductal biopsy

View Large Image Figure ViewerDownload Hi-res image Download (PPT)A 72-year-old man with abdominal pain, hyperamylasemia/lipasemia, and dilatated main pancreatic duct shown by CT underwent MRCP (A, top left) that suggested a mixed-type intraductal papillary mucinous neoplasm (IPMN) with ectasia of multiple branch pancreatic ducts (A, top right) and of the entire dorsal duct (Santorini, 8 mm), draining the dorsal part of the pancreas through minor papilla (A, bottom left), with an incomplete ventral duct (Wirsung, A, bottom right), consistent with pancreas divisum (PD). EUS showed echoic material inside branch duct dilatations (B). Endoscopy showed a typical “fish-mouth” appearance of the minor papilla, draining mucus (C, top left). Pancreatography through the minor papilla confirmed dilatation of the Santorini duct (C, top right). Peroral pancreatoscopy through the minor papilla, with use of the SpyGlass system (Boston Scientific, Boston, Mass, USA), confirmed diffuse dorsal duct dilatation with mucinous material and papillary projections from the intraductal epithelium (C, bottom left). Histologic analysis of targeted intraductal biopsy specimens obtained with SpyBite forceps (Boston Scientific) (C, bottom right) demonstrated a mucin-producing papillary neoplasm with severely atypical cells, suggestive of malignancy (D, left: H&E, orig. mag. ×25). The patient underwent total pancreatectomy (D, middle); final pathologic examination demonstrated malignant IPMN (D, right: H&E, orig. mag. ×50). Patients with PD are at risk for the development of pancreaticobiliary tumors, including IPMN. In patients with PD and dorsal duct dilatation, the coexistence of main-duct IPMN should be considered. Our advice is to perform dorsal duct pancreatoscopy and direct biopsies to reach a final diagnosis. All authors disclosed no financial relationships. Commentary In 2020, most readers of Gastrointestinal Endoscopy should be familiar with the clinical manifestations of intraductal papillary mucinous tumors. Peroral pancreatoscopy with the use of ERCP has been performed in this setting for many years, both to confirm the diagnosis by imaging and perform biopsies and to quantify the extent of disease. Peroral pancreatoscopy can thus help to determine whether a patient would benefit most from a distal pancreatectomy, a pancreaticoduodenectomy, or a total pancreatectomy (as this patient underwent). This patient had pancreas divisum, which allowed peroral pancreatoscopy to be performed through the minor papilla, making the case even more interesting. It should be recognized that peroral pancreatoscopy carries the risk of causing post-ERCP pancreatitis, even in experienced hands, and appropriate steps should be taken to minimize the risk to the patient. Douglas G. Adler, MD, FASGE, GIE Senior Associate Editor, University of Utah School of Medicine, Salt Lake City, Utah Mohamed O. Othman, MD, Associate Editor for Focal Points

Efficacy of digital single-operator cholangioscopy and factors affecting its accuracy in the evaluation of indeterminate biliary stricture

Indeterminate biliary stricture remains a significant diagnostic challenge. The current method of ERCP with bile duct brush cytology has substantial room for improvement. We aimed to determine the efficacy of a digital single-operator cholangioscopy (DSOC) in evaluation of indeterminate biliary stricture. An observational cohort study was conducted among the patients who underwent DSOC for the indication of indeterminate biliary stricture at a tertiary academic medical center. The outcomes of interests were the accuracy of DSOC in visual interpretation and bile duct sample and identification of any factor(s) that could influence its effectiveness. One hundred five patients were included. The overall accuracy of DSOC in visual interpretation was 89.5%, whereas the accuracy of bile duct sample was 83.2%. The sensitivities of visual impression and bile duct sample were 89.1% and 69.8% and their specificities were 90% and 97.9%, respectively. The degree of endoscopists' experience with fewer than 25 cases and the severity of hyperbilirubinemia negatively impacted the accuracy of DSOC. Among 55 patients with definitive diagnosis of malignant stricture, the sensitivity of combined intraductal forceps biopsy sampling and brush cytology was 80.6%, whereas the sensitivity of brush cytology alone was 47.1%. DSOC augments ERCP in evaluating indeterminate biliary stricture. The acquisition of intraductal forceps biopsy samples should be a requisite in evaluation of indeterminate biliary stricture with DSOC. Discovery of modifiable factors such as the degree of endoscopists' expertise and the severity of hyperbilirubinemia, which can influence the accuracy of DSOC, warrants further studies on patient preprocedure optimization and an endoscopic training program that will cultivate procedural competency.

Diagnostic Accuracy of Prostate Biopsy for Detecting Cribriform Gleason Pattern 4 Carcinoma and Intraductal Carcinoma in Paired Radical Prostatectomy Specimens: Implications for Active Surveillance.

Prostatic adenocarcinoma with cribriform morphology and/or intraductal carcinoma has higher recurrence and mortality rates after radiation and surgery. While the prognostic impact of these features is well studied, concordance with cribriform morphology and/or intraductal carcinoma on biopsy and prostatectomy has only recently gained attention. Our primary objective was to evaluate the diagnostic performance of biopsy to detect cribriform morphology and/or intraductal carcinoma in paired biopsy and prostatectomy specimens in a large contemporary cohort. Patients who underwent prostate biopsy or had biopsies reviewed prior to prostatectomy at a tertiary hospital between November 2017 and November 2018 were included in study. Sensitivity and specificity were calculated to assess concordance with cribriform morphology and/or intraductal carcinoma on biopsy and prostatectomy. The association of biopsy diagnosed with cribriform morphology and/or intraductal carcinoma with adverse pathology was assessed by multivariable regression. Of the 455 men who underwent prostatectomy 216 (47.5%) had biopsy identified with cribriform morphology and/or intraductal carcinoma. For cribriform morphology and/or intraductal carcinoma the sensitivity and specificity of biopsy was 56.5% and 87.2%, respectively. In men eligible for active surveillance sensitivity was 34.1% and specificity was 88.1%. Magnetic resonance imaging targeted biopsies did not improve sensitivity (53.5%). Cribriform morphology and/or intraductal carcinoma identified on prostatectomy correlated with adverse pathological findings. However, compared to cribriform morphology and/or intraductal carcinoma negative biopsies, biopsies identified with cribriform morphology and/or intraductal carcinoma were not independently associated with adverse pathology. This was likely due to biopsy low sensitivity. In this cohort biopsy was not sensitive for detecting cribriform morphology and/or intraductal carcinoma and this was not improved by magnetic resonance imaging fusion. However, specificity was high, suggesting that when present on biopsy, cribriform morphology and/or intraductal carcinoma may be considered in treatment planning algorithms.