Indeterminate Biliary Strictures Research Articles

Su1582 EFFICACY OF DIGITAL SINGLE-OPERATOR CHOLANGIOSCOPY IN THE VISUAL INTERPRETATION OF BILIARY MALIGNANCIES: A SYSTEMATIC REVIEW AND META-ANALYSIS

Indeterminate biliary stricture remains a significant diagnostic challenge. Digital single-operator cholangioscopy (D-SOC) incorporates digital imaging enabling higher resolution for better visualization and diagnosis of biliary lesions. We aimed to conduct a systematic review and meta-analysis of available literature in an attempt to determine the efficacy of D-SOC in the visual interpretation of biliary malignancies. Electronic searches were performed using Medline (PubMed), EMBASE, and Cochrane Library. All D-SOC studies that reported the diagnostic performance in the visual interpretation of indeterminate biliary strictures and biliary malignancies were included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 was used to evaluate the quality of the included studies. All data were extracted and pooled to construct a 2x2 table. The visual interpretation of D-SOC was compared with either a surgical specimen or clinical follow-up in the included patients. Pooled sensitivity, specificity, positive predictive value, negative predictive value, prevalence, positive likelihood ratio (+LR), negative likelihood ratio (-LR), and diagnostic odds ratio (OR) were calculated. The summarized receiver operating characteristic (SROC) curve corresponding with the area under the curve (AUC) was also analyzed. The search yielded 465 citations. Out of these, six studies with a total of 283 patients were finally included in the meta-analysis. The overall pooled sensitivity and specificity of D-SOC in the visual interpretation of biliary malignancies was 94% (95% CI 89%-97%) and 95% (95%CI 90%–98%), respectively (Figure 1). While the +LR, -LR, diagnostic OR, and AUC were 15.20 (95%CI 5.21–44.33), 0.08 (95%CI 0.04–0.14), 308.83 (95%CI 106.46–872.82), and 0.983 respectively (Table 1). The heterogeneity among 6 included studies was moderate for specificity (I2=51) and low for sensitivity (I2=17) and diagnostic OR (I2 = 0). D-SOC has excellent efficacy in the visual interpretation of biliary malignancies, and these findings were consistent in all included studies. Thus, accurate visual interpretation with D-SOC should be routinely employed in the evaluation of indeterminate biliary stricture to identify biliary malignancies.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Su1524 ROLE OF DIGITAL SPYGLASSTM CHOLANGIOSCOPY IN PRIMARY SCLEROSING CHOLANGITIS PATIENTS

Endoscopic Retrograde Cholangiopancreatography (ERCP) in primary sclerosing cholangitis (PSC) subjects with dominant biliary strictures can be challenging to: 1) access and treat strictures; 2) treat intrahepatic calculi; or 3) exclude cholangiocarcinoma (CCA). This study aimed to evaluate the utility and safety of digital SpyGlassTM cholangioscopy (Boston Scientific, Massachusetts) in PSC patients with complex biliary strictures. Prospective data was collected on cholangioscopy subjects between June 2015-August 2019 including demographics, biochemistry, cholangioscopy indications, cross sectional imaging, endoscopic and fluoroscopic videos, histopathology and cytology. 27 PSC patients median age 60 (21-81) yrs, 17M, 10F underwent 40 (1-4) procedures. 6 (21%) patients had cirrhosis. Indications (often multiple) included indeterminate biliary strictures (17); cholangitis (6); biliary stones (5) or segments not accessed by ERCP (12). The median pre-procedural bilirubin was 36 (2-235) μmol/L. Cholangioscopy procedural time was median 36 (17–126) mins. Dominant biliary strictures treated were intrahepatic (15) and/or extrahepatic (12). In 25 (92%) patients, all obstructed biliary segments were eventually accessed. In the 2 where all segments could not be accessed, 1 proceeded to liver resection and 1 orthotopic liver transplantation (OLT). Strictures were balloon dilatated in 23 patients while 7 required biliary stents. Three of 5 patients had intrahepatic calculi completely cleared with Holmium laser lithotripsy, 2 others with multiple stones had incomplete clearance (1 sent for OLT, the other confirmed CCA stented). CCA was diagnosed in 4 of 27 patients, all had preceding negative cross-sectional imaging. Cholangioscopy-directed biopsies were at least suspicious for malignancy in 3 of 4 cases while aspiration cytology was suspicious in 2 of 3. The stricture cholangioscopy visual appearance appeared benign in 12 of 27 cases (final diagnosis [FD] benign 12); malignant in 2 (FD malignant 2) and; indeterminate in 13 (FD malignant 2, benign 11) (Figures 1 & 2). Two of the 4 cases with early CCA were able to be referred for OLT. Complications (all mild) occurred in 7 of 40 (15%) procedures (cholangitis 4, pancreatitis 1, haemobilia 1, pneumonia 1). In certain PSC patients undergoing cholangioscopy:

SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy.

Confocal laser endomicroscopy (CLE) is a novel endoscopic adjunct that allows real-time in vivo histological examination of mucosal surfaces. By using intravenous or topical fluorescent agents, CLE highlights certain mucosal elements that facilitate an optical biopsy in real time. CLE technology has been used in different organ systems including the gastrointestinal tract. There has been numerous studies evaluating this technology in gastrointestinal endoscopy, our aim was to evaluate the safety, value, and efficacy of this technology in the gastrointestinal tract. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC) performed a PubMed/Medline database search of clinical studies involving CLE in May of 2018. The literature search used combinations of the keywords: confocal laser endomicroscopy, pCLE, Cellvizio, in vivo microscopy, optical histology, advanced endoscopic imaging, and optical diagnosis. Bibliographies of key references were searched for relevant studies not covered by the PubMed search. Case reports and small case series were excluded. The manufacturer's website was also used to identify key references. The United States Food and Drug Administration (U.S. FDA) Manufacturer And User facility and Device Experience (MAUDE) database was searched for reports regarding the device malfunction or injuries. The technology offers an excellent safety profile with rare adverse events related to the use of fluorescent agents. It has been shown to increase the detection of dysplastic Barrett's esophagus, gastric intraepithelial neoplasia/early gastric cancer, and dysplasia associated with inflammatory bowel disease when compared to standard screening protocols. It also aids in the differentiation and classification of colorectal polyps, indeterminate biliary strictures, and pancreatic cystic lesions. CLE has an excellent safety profile. CLE can increase the diagnostic accuracy in a number of gastrointestinal pathologies.

Efficacy of digital single-operator cholangioscopy in the visual interpretation of indeterminate biliary strictures: a systematic review and meta-analysis.

Indeterminate biliary strictures remain a significant diagnostic challenge. Digital single-operator cholangioscopy (D-SOC) incorporates digital imaging which enables higher resolution for better visualization and diagnosis of biliary pathology. We aimed to conduct a systematic review and meta-analysis of available literature in an attempt to determine the efficacy of D-SOC in the visual interpretation of indeterminate biliary strictures. Electronic searches were performed using Medline (PubMed), EMBASE, and Cochrane Library. All D-SOC studies that reported the diagnostic performance in visual interpretation of indeterminate biliary strictures and biliary malignancies were included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 was used to evaluate the quality of the included studies. All data were extracted and pooled to construct a 2 × 2 table. The visual interpretation of D-SOC was compared to resected surgical specimens or clinical follow-up in the included patients. Pooled sensitivity, specificity, positive predictive value, negative predictive value, prevalence, positive likelihood ratio (+LR), negative likelihood ratio (-LR), and diagnostic odds ratio (OR) were calculated. The summarized receiver operating characteristic (SROC) curve corresponding with the area under the curve (AUC) was also analyzed. The search yielded 465 citations. Of these, only six studies with a total of 283 procedures met inclusion criteria and were included in the meta-analysis. The overall pooled sensitivity and specificity of D-SOC in the visual interpretation of biliary malignancies was 94% (95% CI 89-97) and 95% (95%CI 90-98), respectively, while +LR, -LR, diagnostic OR, and AUC were 15.20 (95%CI 5.21-44.33), 0.08 (95%CI 0.04-0.14), 308.83 (95%CI 106.46-872.82), and 0.983, respectively. The heterogeneity among 6 included studies was moderate for specificity (I2 = 0.51) and low for sensitivity (I2 = 0.17) and diagnostic OR (I2 = 0.00). D-SOC is associated with high sensitivity and specificity in the visual interpretation of indeterminate biliary strictures and malignancies. D-SOC should be considered routinely in the diagnostic workup of indeterminate biliary lesions.

Indeterminate biliary stricture treated by antegrade cholangioscopy through an endoscopic ultrasound-guided hepaticojejunostomy.

Indeterminate biliary stricture treated by antegrade cholangioscopy through an endoscopic ultrasound-guided hepaticojejunostomy.

Using single-operator cholangioscopy for endoscopic evaluation of indeterminate biliary strictures: results from a large multinational registry.

Peroral cholangioscopy (POCS) of indeterminate biliary strictures aims to achieve a diagnosis through visual examination and/or by obtaining targeted biopsies under direct visualization. In this large, prospective, multinational, real-life experience of POCS-guided evaluation of indeterminate biliary strictures, we evaluated the performance of POCS in this difficult-to-manage patient population. This prospective registry enrolled patients, with indeterminate biliary strictures across 20 centers in Asia, the Middle East, and Africa. The primary end points were the ability to visualize the lesion, obtain histological sampling when intended, and an assessment of the diagnostic accuracy of POCS for malignant strictures. Patients were followed for 6 months after POCS or until a definitive malignant diagnosis was made, whichever occurred first. 289 patients underwent 290 POCS procedures with intent to biopsy in 182 cases. The stricture/filling defect was successfully visualized in 286/290 (98.6 %), providing a visual diagnostic impression in 253/290 (87.2 %) and obtaining adequate biopsies in 169/182 (92.9 %). Procedure-related adverse events occurred in 5/289 patients (1.7 %). POCS influenced patient management principally by elucidating filling defects or the causes of bile duct stricture or dilation. The visual impression of malignancy showed 86.7 % sensitivity, 71.2 % specificity, 65.8 % positive and 89.4 % negative predictive value, and 77.2 % overall accuracy compared with final diagnosis. Histological POCS-guided samples showed 75.3 % sensitivity, 100 % specificity, 100 % positive and 77.1 % negative predictive value, and 86.5 % overall accuracy. In this large, real-life, prospective series, POCS was demonstrated to be an effective and safe intervention guiding the management of patients with indeterminate biliary strictures.

The utility of digital cholangioscopy (SpyGlass DS) in biliary and pancreatic diseases: A clinical feasibility study at two tertiary care centers in Saudi Arabia (with Videos)

Background and study aimSince its inception in 2007, single-operator cholangioscopy (SOC) has gained popularity for many diagnostically and therapeutically challenging biliary and pancreatic conditions. Many studies have been published to evaluate the feasibility, usefulness, cost-effectiveness, and safety profile of the first generation. This paper is a descriptive study in which we aim to share the experience of two tertiary care centers with the novel version of SOC, SpyGlass DS. Patients and methodsWe retrospectively reviewed the records of all the patients who went through the procedure from October 2015 - July 2019 to explore the scope of biliary and pancreatic conditions in which SOC was utilized. Technical success was defined as the ability to visualize the lesion and complete the procedure as planned, whereas clinical success was determined by the ability to achieve the desired diagnostic/therapeutic outcome. ResultsDuring the period of interest, 66 patients (34 males) went through 84 cholangioscopy procedures. Forty-four patients failed the conventional extraction methods and needed the intervention for the treatment of difficult stones, 24 patients needed a diagnostic evaluation of biliary strictures, and 3 needed an intervention to remove migrated stents. Technical success was achieved in 98.8% (83/84) of the procedures (95% CI: 96–100%). Regarding clinical success, stone breakdown and removal was achieved in 92% of the procedures (49/53; 95% CI: 85–100%). Tissue samples were successfully obtained in 95.8% (23/24) of patients with strictures (95% CI: 88–100%). The biopsy was appropriate to make a histological diagnosis in 83.3% of cases (20/24; 95% CI: 68–98%). The median number of sessions needed to achieve the deisred outcome was one (ranging between 1 and 6 sessions). ConclusionThe new version of SOC, SpyGlass DS, provides a feasible and an effective option for the management of difficult cholelithiasis, as well as visually evaluating and obtaining histological samples for indeterminate biliary strictures. However, data from more extensive studies are needed to establish its non-inferiority to the fiberoptic version in terms of short- and long-term outcomes, cost-effectiveness, and complications.

A275 REVISITING THE DIAGNOSTIC YIELD OF ERCP BRUSH CYTOLOGY FOR INDETERMINATE BILIARY STRICTURES

Abstract Background Endoscopic Retrograde Cholangiopancreatography (ERCP) brush cytology is the most frequently used tool for sampling indeterminate biliary strictures. Previous studies have demonstrated that the diagnostic yield of brush cytology for malignant biliary strictures is 60%. With improved diagnostic tools, sampling techniques and specimen processing, the yield of ERCP brush cytology may be higher. Aims To assess the diagnostic yield of ERCP brush cytology in patients with indeterminate biliary strictures and to determine factors associated with positive diagnosis. Methods This is a retrospective study of all patients who underwent ERCP with brush cytology at University Health Network (UHN) from October 2016 to September 2019. The cytological samples were taken as follows: the cytology brush is introduced into the stricture ten times under direct fluoroscopy guidance. The brush was cut and placed into a methanol based buffered solution (CytoLyt®). Residual sample was then flushed out of the catheter with the solution and into the sample container. Patient demographic, clinical, procedural and pathological data was collected by chart review. All patients were followed for a minimum of three months after their index ERCP. Post-ERCP sampling via repeat ERCP brushings, endoscopic ultrasound fine needle biopsy, percutaneous biopsy or surgical resection was recorded. Results A total of 97 patients underwent ERCP with brush cytology during the study period (43 females, median age 69 years). Fifty-nine patients (84%) were diagnosed with malignancy via ERCP brush cytology. Using follow up sampling, surgical resection and clinical follow up as the gold standard, the sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 84%, 100%, 100%, and 71% respectively. Patient demographics, degree of cholestasis or stricture location had no significant impact on these outcomes. Conclusions This study shows a high diagnostic yield for ERCP with brush cytology for patients with indeterminate biliary strictures. Large prospective studies using updated tools, techniques and specimen handling processes are needed to confirm our observations. Funding Agencies None

Digital Single-operator Cholangioscopy (DSOC) Improves Interobserver Agreement (IOA) and Accuracy for Evaluation of Indeterminate Biliary Strictures

Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC. In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate. In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%. The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies.

Role of Peroral Cholangioscopy for Diagnosis and Staging of Biliary Tumors

Objectives: Peroral cholangioscopy (POC) has shown to be a useful diagnostic procedure in the evaluation of biliary strictures; however, data regarding its role on preoperative staging are scarce. The aim of this study was to evaluate POC role in the diagnosis and preoperative intraductal staging of perihilar cholangiocarcinoma (CCA). Methods: Retrospective study that included all patients who underwent POC with SpyGlass^TM Direct Visualization System for the diagnosis of biliary strictures or for preoperative evaluation of extrahepatic biliary tumors, between 2015 and 2019, in a single tertiary center. Results: Forty-three patients were included, 63% male with a median age of 62 years. Thirty-eight (88.3%) underwent POC due to indeterminate biliary strictures, 3 (7%) due to bile duct filling defect, and 2 (4.7%) for intraductal staging of perihilar CCA. In the follow-up, a final diagnosis of malignancy was established in 56% of the patients. Visual impression accuracy with SpyGlass was 95.1% (with 100% sensitivity and 89.5% specificity). SpyBite biopsies accuracy was 80.5% (63.6% sensitivity and 100% specificity). In the 19 patients with a final perihilar CCA diagnosis, intraductal evaluation with SpyGlass altered anatomic classification (Bismuth-Corlette) defined by previous imagiologic findings in 8 (42.1%) patients. Alteration in anatomic classification changed therapeutic approach in 4 (21%). Conclusions: POC use for evaluating intraductal spread in potentially resectable perihilar CCA can detect more extensive and change surgical management. In the future, preoperative staging of perihilar CCA with POC combined with imagiologic evaluation of vascular extension of the lesions may optimize surgical results.

Ethanol-based fixation is superior to conventional brush cytology in the evaluation of indeterminate biliary strictures by endoscopic retrograde cholangiography

The aim of this study was to compare the diagnostic yield of conventional cytology (CC) with ethanol-based fixation, a cytological analysis using an ethanol based fixative system including a cell block procedure (EBF) to evaluate indeterminate biliary strictures (IBStr). We also compared additionally taken fluorescence-guided forceps biopsies (FB) with EBF concerning a potential additive diagnostic benefit.Early detection and accurate diagnosis are crucial for patients with suspected carcinoma within the biliary tree to preserve curative treatment options but diagnostics and patient care in the evaluation of IBStr are still challenging. ERC-guided brush cytology is the gold standard of nonsurgical evaluation of IBStr. However, accuracy is generally low. New specimen processing's are needed to higher the diagnostic yield in the evaluation of IBStr.We performed a retrospective evaluation in 404 patients referred for further diagnosis of IBStr. Gold standard was defined as surgically obtained histology or patient follow-up of at least 1 year to diagnose or exclude malignancy.Three hundred thirty-four patients were included into the final analysis. One hundred seventy-two strictures were malignant, 162 strictures benign. One hundred seventeen specimens were evaluated by CC, 217 processed by EBF. EBF performed significantly better in terms of sensitivity (24.6% vs 60%, P < .001) and accuracy (59.0% vs 75.1%, P = .006). Fifty-eight FB were additionally taken and showed a numerically improved sensitivity compared to EBF alone (80% vs 62.9%, P = .19).EBF is a simple and inexpensive technique that substantially improved sensitivity and accuracy in the evaluation of IBStr. FB specimen did not significantly improve diagnostic yield.

New staining method using methionyl-tRNA synthetase 1 antibody for brushing cytology of bile duct cancer

Identifying malignant biliary strictures using endobiliary brushing cytology specimens is important for treatment decision-making and prognosis prediction. The sensitivity of brushing cytology specimens based on Papanicolaou (Pap) staining is low, which hampers accurate diagnosis of indeterminate strictures. Here, we assessed the diagnostic value of immunohistochemical (IHC) and immunofluorescence (IF) staining for methionyl-tRNA synthetase 1 (MARS1). Endobiliary brushing cytology specimens were obtained during ERCP from 80 patients with an extrahepatic biliary stricture. Pap and MARS1 IF staining were performed on liquid-based cytology slides derived from these specimens. Sections of bile duct adenocarcinoma and normal bile duct tissue were obtained from 45 patients who underwent surgery for malignant biliary stricture, and MARS1 levels were evaluated by IHC staining. MARS1 IF staining was applied to brushing cytology specimens, and the results showed strong signals in malignant biliary structures but not in the negative for malignancy specimens. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 70.4%, 96.2%, 97.4%, 56.8%, and 78.8%, respectively, for conventional Pap staining and 98.1%, 96.1%, 98.1%, 96.2%, and 97.5%, respectively, for MARS1 IF (P< .0001). When IHC staining was used, MARS1 was detected in 45 bile duct adenocarcinoma sections but not in 15 normal bile duct sections. Moreover, MARS1 mRNA and protein levels were significantly higher in bile duct adenocarcinoma sections according to polymerase chain reaction and Western blot, respectively. The high sensitivity and accuracy of MARS1 IF staining enabled detection of malignancy in patients with indeterminate biliary stricture. Further prospective studies are needed to validate our findings. (Clinical trial registration number: KCT 0003285.).

The endoscopic approach to indeterminate biliary stricture: currentpractice and future perspective

Patients with indeterminate biliary stricture frequently pose a challenge in the clinical management. Patients with malignant and potentially resectable diseases should be treated surgically as soon as possible. On the other hand, in patients with benign diseases which might be cured with medial treatment, surgery should be avoided. This review shall provide a concise overview on the diagnostic yield of currently available endoscopic methods as well as describe methods of potential relevance in the future.

Limited diagnostic accuracy and clinical impact of single-operator peroral cholangioscopy for indeterminate biliary strictures.

Single-operator peroral cholangioscopy (sPOCS) is considered a valuable diagnostic modality for indeterminate biliary strictures. Nevertheless, studies show large variation in its characteristics and measures of diagnostic accuracy. Our aim was to estimate the diagnostic accuracy of sPOCS visual assessment and targeted biopsies for indeterminate biliary strictures. Additional aims were: estimation of the clinical impact of sPOCS and comparison of diagnostic accuracy with brush cytology. A retrospective single-center study of adult patients who underwent sPOCS for indeterminate biliary strictures was performed. Diagnostic accuracy was defined as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The clinical impact of sPOCS was assessed by review of medical records, and classified according to its influence on patient management. 80 patients were included, with 40 % having primary sclerosing cholangitis (PSC). Prior ERCP was performed in 88 %, with removal of a biliary stent prior to sPOCS in 55 %. The sensitivity, specificity, PPV, and NPV for sPOCS visual impression and targeted biopsies were 64 %, 62 %, 41 %, and 84 %, and 15 %, 65 %, 75 %, and 69 %, respectively. The clinical impact of sPOCS was limited; outcome changed management in 17 % of patients. Sequential brush cytology sensitivity, specificity, PPV, and NPV were 47 %, 95 %, 80 %, and 83 %. The diagnostic accuracy of sPOCS for indeterminate biliary strictures was found to be inferior to brush cytology, with a low impact on patient management. These findings are obtained from a select patient population with a high prevalence of PSC and plastic stents in situ prior to sPOCS.

Issue Highlights

Issue Highlights

Frequency of malignant biliary strictures in Upper Egypt: a pilot study

Background and aimBiliary strictures are challenging clinical condition for gastroenterologists, radiologists, and surgical specialists. We aimed to find out the frequency of malignant biliary strictures in our institutions.Patients and methodsThis prospective study included 44 patients with biliary strictures who had undergone endoscopic retrograde cholangiopancreatography (ERCP) and magnetic resonance cholangiopancreatography (MRCP) in Aswan and Assiut University Hospitals.ResultsThirty two patients (72.7%) had malignant strictures where distal stricture was the most frequent (68.8%) followed by hilar (25%) then mid and long segment strictures (3.1% each).ConclusionThe vast majority of indeterminate biliary strictures are malignant (72.7%), so all indeterminate bile duct strictures in patients with obstructive jaundice should be considered malignant unless a benign etiology is definitively identifiable.

Digital single-operator peroral cholangioscopy-guided biopsy sampling versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized, multicenter trial (with video)

Accurately diagnosing indeterminate biliary strictures is challenging but important for patient prognostication and further management. Biopsy sampling under direct cholangioscopic vision might be superior to standard ERCP techniques such as brushing or biopsy sampling. Our aim was to investigate whether digital single-operator cholangioscopy (DSOC) compared with standard ERCP workup improves the diagnostic yield in patients with indeterminate biliary strictures. Patients with an indeterminate biliary stricture on the basis of MRCP were randomized to standard ERCP visualization with tissue brushing (control arm [CA]) or DSOC visualization and DSOC-guided biopsy sampling (study arm [SA]). This was a prospective, international, multicenter trial with a procedure-blinded pathologist. The first sample sensitivity of DSOC-guided biopsy samples was significantly higher than ERCP-guided brushing (SA 68.2% vs CA 21.4%, P< .01). The sensitivity of visualization (SA 95.5% vs CA 66.7%, P= .02) and overall accuracy (SA 87.1% vs CA 65.5%, P= .05) were significantly higher in the SA compared with the CA, whereas specificity, positive predictive value, and negative predictive value showed no significant difference. Adverse events were equally low in both arms. DSOC-guided biopsy sampling was shown to be safe and effective with a higher sensitivity compared with standard ERCP techniques in the visual and histopathologic diagnosis of indeterminate biliary strictures. (Clinical trial registration number: NCT03140007.).

Role of DIA in Diagnosing Nature of Indeterminate Biliary Duct Stricture

Role of DIA in Diagnosing Nature of Indeterminate Biliary Duct Stricture

874 Sensitivity of Endoscopic Modalities for Diagnosis of Malignant Biliary Strictures: Experiences From Referral Hospitals in Eastern and Western Countries

INTRODUCTION: Indeterminate biliary strictures require further investigations to exclude malignancy. Cholangioscopy allows direct visualization of the bile duct as well as the ability to target the specific area for biopsy. This study aims to evaluate the sensitivity of endoscopic modalities including cholangioscopy-guided (miniature) biopsies ± brushings and/or fluoroscopy-guided biopsy (regular) biopsies for diagnosis of malignant biliary strictures in a real-world practice. METHODS: Endoscopy databases between 2015-2018 from two referral hospitals, one in USA and the other in Thailand, were retrospectively reviewed. Patients with indeterminate biliary stricture underwent ERCP and digital cholangioscopy-guided biopsy were included. Malignancy was confirmed by cytology or histology obtained by ERCP, surgery, or intervention-guided biopsy. Benign disease was confirmed by no disease progression and patient survived more than 6 months. RESULTS: A total of 58 patients (USA = 20 and Thailand = 38) with indeterminate biliary stricture underwent ERCP and cholangioscopy-guided biopsy were included. Forty-three patients had malignant strictures and 15 patients had benign strictures. The most common cause of malignant biliary stricture was cholangiocarcinoma (76.7%) and the most common cause of benign biliary stricture was IgG4-sclerosing cholangitis (46.7%). The majority of tissue acquisition was obtained by a combination of miniature biopsies + brushings + regular biopsies in 24 patients (41.4%) followed by a combination of miniature biopsies + regular biopsies in 20 patients (34.5%). Miniature biopsies alone was more frequently used in the USA site (30%) when compare with the Thailand site (5.3%). Sensitivity per methods of tissue acquisition were 12%, 48.8%, and 64.7% in brushings, miniature biopsies, and regular biopsies, respectively. Brushings had the lowest sensitivity in both centers (0% in USA and 18.8% in Thailand). Miniature biopsies had the highest sensitivity in the USA site (42.9%) and biopsy had the highest sensitivity in the Thailand site (65.4%). A combination of tissue acquisition methods provided the highest sensitivity, which was able to increase the sensitivity up to 10.5%. CONCLUSION: Cholangioscopy-guided biopsies are able to diagnose cancer in a half of patient who presented with indeterminate biliary stricture. Nevertheless, a combination of miniature biopsies with other tissue acquisition methods was more commonly utilized and had higher diagnostic yield than miniature biopsy alone.

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.