Diagnosis Of Malignant Biliary Strictures Research Articles

Effect of modified biopsy forceps on the diagnosis of malignant biliary strictures: A randomized controlled trial.

Effect of modified biopsy forceps on the diagnosis of malignant biliary strictures: A randomized controlled trial.

S154 Prospective Evaluation of Practice Patterns and Diagnostic Performance of Sampling Techniques for Diagnosis of Malignant Biliary Strictures

S154 Prospective Evaluation of Practice Patterns and Diagnostic Performance of Sampling Techniques for Diagnosis of Malignant Biliary Strictures

Diagnostic utility of quantitative analysis of microRNA in bile samples obtained during endoscopic retrograde cholangiopancreatography for malignant biliary strictures.

The sensitivity of bile cytology for malignant biliary strictures is not adequate. To overcome this limitation, we evaluated whether quantitative analysis of microRNAs (miRNAs) in bile can provide a precise diagnosis of malignant biliary strictures due to pancreatic cancer (PC) and biliary tract cancer (BTC). This was a retrospective evaluation of miRNA levels in stored bile samples of patients with PC, BTC or benign biliary stricture obtained during biliary drainage from April 2019 to December 2021 at our institution. A total of 113 patients (PC; n = 40, BTC; n = 38, control; n = 35) were enrolled. The miRNA candidates to be quantified were determined with microarray analysis from each 3 patients with PC, BTC and controls. Using microarray analysis, we confirmed four significantly up-regulated miRNAs (miR-1275, miR-6891-5p, miR-7107-5p, miR-3197) in patients with PC and BTC compared to control patients. Quantitative PCR was then performed in 113 bile samples for these miRNAs. miR-1275 was significantly upregulated in PC (p = 0.003) and BTC (p = 0.049) compared to controls, miR-6891-5p was significantly upregulated in PC compared to controls (p = 0.025). In particular, a combination of bile cytology and miR-1275 in bile showed a sensitivity of 77.5% (95% CI, 70.7-77.5%), specificity of 100% (95% CI, 92.2-100%) and an area under the curve (AUC) of 0.93, and provided a significantly greater additional diagnostic effect than bile cytology alone (p = 0.014). This study suggest that bile miRNAs could be potential biomarkers for pancreato-biliary diseases, particularly miR-1275 and miR-6891-5p may be helpful in the diagnosis of PC and BTC.

A real-time interpretable artificial intelligence model for thecholangioscopic diagnosis of malignant biliary stricture (with videos).

It is crucial to accurately determine malignant biliary strictures (MBSs) for early curative treatment. This study aimed to develop a real-time interpretable artificial intelligence (AI) system to predict MBSs under digital single-operator cholangioscopy (DSOC). A novel interpretable AI system called MBSDeiT was developed consisting of 2 models to identify qualified images and then predict MBSs in real time. The overall efficiency of MBSDeiT was validated at the image level on internal, external, and prospective testing data sets and subgroup analyses, and at the video level on the prospective data sets; these findings were compared with those of the endoscopists. The association between AI predictions and endoscopic features was evaluated to increase the interpretability. MBSDeiT can first automatically select qualified DSOC images with an area under the curve (AUC) of .963 and .968 to .973 on the internal testing data set and the external testing data sets, and then identify MBSs with an AUC of .971 on the internal testing data set, an AUC of .978 to .999 on the external testing data sets, and an AUC of .976 on the prospective testing data set, respectively. MBSDeiT accurately identified 92.3% of MBSs in prospective testing videos. Subgroup analyses confirmed the stability and robustness of MBSDeiT. The AI system achieved superior performance to that of expert and novice endoscopists. The AI predictions were significantly associated with 4 endoscopic features (nodular mass, friability, raised intraductal lesion, and abnormal vessels; P< .05) under DSOC, which is consistent with the endoscopists' predictions. The study findings suggest that MBSDeiT could be a promising approach for the accurate diagnosis of MBSs under DSOC.

Diagnostic value of new biliary biopsy cannulae for malignant bile duct strictures via endoscopic retrograde cholangiopancreatography pathway

BackgroundEndoscopic retrograde cholangiopancreatography (ERCP) plays a major role in the diagnosis of malignant biliary strictures. ERCP fluoroscopy-guided biliary biopsy is more sensitive than brushing, but it is more difficult to perform and less successful. Therefore, a new technique of biliary biopsy using a new biliary biopsy cannula via the ERCP route was developed in our center with the aim of improving the diagnosis rate of malignant biliary strictures. MethodsThis is a retrospective study that included 42 patients who underwent ERCP-guided biliary brushing and biliary biopsy for biliary strictures using a new biliary biopsy cannula in our department from January 2019 to May 2022. The final diagnosis was determined after brushing, biliary biopsy under the new biliary biopsy cannula or adequate follow-up. Diagnostic rates were calculated and analyzed for relevant factors. ResultsThe satisfactory rates of pathological specimens of 42 patients who underwent bile duct biopsy with bile duct brush and new bile duct biopsy cannula were 57.14% and 95.24% respectively. Cholangiocarcinoma was diagnosed in 45.23% and 83.30% of the samples by biliary brush examination and biliary biopsy using the new biliary biopsy cannula, respectively (p < 0.001). ConclusionsThe ERCP route using a new biliary biopsy cannula for biliary biopsy technique can improve pathology positivity and benefit ratio. It provides a new approach in the diagnosis of malignant stenosis in the bile duct.

Effectiveness for Diagnosis of Malignancy of Bile Pyruvate Kinase M2 in Patients with Indeterminate Biliary Stricture.

Up to 70% of the cases of biliary strictures are cholangiocarcinoma. Cholangiocarcinoma has a late diagnosis and poor outcomes; therefore, effective biomarkers are needed for malignant lesions detection at earlier stages. The aim was to assess the diagnostic utility of bile pyruvate kinase M2 (PKM2) as a biomarker for the detection of malignant biliary strictures in patients with an indeterminate biliary stricture. This is a prospective study to evaluate the diagnostic value of bile PKM2 for the diagnosis of malignant biliary strictures. Bile samples were collected during Endoscopic Retrograde Cholangio Pancreatography to quantify PKM2 levels and were used to compare their diagnostic value with biliary brush cytology, endoscopic ultrasound-guided fine needle biopsy, or clinical follow-up. Forty-six patients were recruited for the study; 19 patients with malignant strictures and 27 with benign biliary strictures. The bile PKM2 levels were elevated in patients with malignant biliary strictures [median 0.045ng/mL (IQR 0.014 to 0.092)] compared with those with benign strictures [median 0.019ng/mL (IQR 0.00 to 0.047)]. Bile PKM2 had a receiver-operating characteristic curve of 0.66 (0.49 to 0.83) with a cutoff value of bile PKM2 of 0.0017ng/mL. The sensitivity and specificity of bile PKM2 for the diagnosis of cholangiocarcinoma were 89% and 26%; the positive and negative predictive values were 46% and 78%, respectively. In patients with indeterminate biliary strictures, bile PKM2 may be a potential biomarker for the diagnosis of malignancy.

Artificial intelligence in endoscopic imaging for detection of malignant biliary strictures and cholangiocarcinoma: a systematic review.

Artificial intelligence (AI), when applied to computer vision using a convolutional neural network (CNN), is a promising tool in "difficult-to-diagnose" conditions such as malignant biliary strictures and cholangiocarcinoma (CCA). The aim of this systematic review is to summarize and review the available data on the diagnostic utility of endoscopic AI-based imaging for malignant biliary strictures and CCA. In this systematic review, PubMed, Scopus and Web of Science databases were reviewed for studies published from January 2000 to June 2022. Extracted data included type of endoscopic imaging modality, AI classifiers, and performance measures. The search yielded 5 studies involving 1465 patients. Of the 5 included studies, 4 (n=934; 3,775,819 images) used CNN in combination with cholangioscopy, while one study (n=531; 13,210 images) used CNN with endoscopic ultrasound (EUS). The average image processing speed of CNN with cholangioscopy was 7-15 msec per frame while that of CNN with EUS was 200-300 msec per frame. The highest performance metrics were observed with CNN-cholangioscopy (accuracy 94.9%, sensitivity 94.7%, and specificity 92.1%). CNN-EUS was associated with the greatest clinical performance application, providing station recognition and bile duct segmentation; thus reducing procedure length and providing real-time feedback to the endoscopist. Our results suggest that there is increasing evidence to support a role for AI in the diagnosis of malignant biliary strictures and CCA. CNN-based machine leaning of cholangioscopy images appears to be the most promising, while CNN-EUS has the best clinical performance application.

Use of Endoscopic Scraper and Cell Block Technique as a Replacement for Conventional Brush for Diagnosing Malignant Biliary Strictures.

Simple SummaryBrush cytology remains the primary method used worldwide for diagnosing malignant biliary strictures, despite its low sensitivity. Although the endoscopic scraper, the simplicity of which is comparable to that of a conventional brush, has been used mainly in Japan, it has yet to gain popularity on a global scale. The purpose of this study was to evaluate the diagnostic performance of the endoscopic scraper by comparing diagnostic yields and the number of collected cells using quantitative digital image analysis. Our study revealed that the endoscopic scraper and cell block method achieved higher sensitivity than the brush with the cell block method, and showed that the number of cells on the cell block sections obtained by the endoscopic scraper were significantly higher than those obtained using the brush. Given its ease of use and high sample acquisition capability, the endoscopic scraper could replace brush cytology for diagnosing malignant biliary strictures.Histological evidence is essential for diagnosing malignant biliary strictures. However, conventional brush cytology remains the primary method used worldwide, despite its low diagnostic sensitivity and accuracy, as it is technically easy, rapid, and cost-effective. The aim of this study was to evaluate the diagnostic performance of a recently introduced endoscopic scraper, the simplicity of which is comparable to that of a conventional brush, by comparing diagnostic yields and the number of collected cells. The sensitivity of the endoscopic scraper when using the cell block technique was significantly higher than when using brush cytology or a brush with the cell block technique (53.6% vs. 30.9%, p < 0.001; 53.6% vs. 31.6%, p = 0.024, respectively). Quantitative digital image analysis of cell block sections revealed that the median number of cells obtained with the endoscopic scraper was significantly higher than when using the brush (1917 vs. 1014 cells, p = 0.042). Furthermore, seven cases (8.3%; 7/84) were diagnosed by immunohistochemical analysis of the cell block section obtained from the endoscopic scraper. Given its simplicity and greater capacity for sample acquisition, use of the endoscopic scraper in conjunction with the cell block technique could replace brush cytology for the histological diagnosis of malignant biliary strictures.

Evaluation of the Cell Block Method Using Overnight-Stored Bile for Malignant Biliary Stricture Diagnosis.

Simple SummaryCollecting specimens for pathological diagnosis of malignant biliary stricture (MBS) is not easy. This study shows that cell block (CB) of overnight-stored bile is useful for pathological diagnosis of MBS. Cancer detectability using the CB method (62.2%) is superior to that using cytology (37.8%). When the CB method is combined with biopsy, the cancer detectability (75.6%) and accuracy rates (81.4%) are increased. In addition, immunohistochemistry can be applied to the CB method when encountering difficult cases for pathological diagnosis. The CB method utilizing overnight-stored bile can be routinely used for detecting MBS in local hospitals.The specimen collection and subsequent pathological diagnosis of malignant biliary stricture (MBS) are difficult. This study aimed to determine whether the cell block (CB) method using overnight-stored bile is useful in the diagnosis of MBS. This trial was a single-arm prospective study involving a total of 59 patients with suspected MBS. The primary endpoint was cancer detectability and accuracy using the CB method, and a comparison with the detectability and accuracy achieved with bile cytology was made. The immunohistochemical sensitivity for maspin and p53 was also investigated in the CB and surgical specimens. We were able to collect bile from all 59 patients, and 45 of these patients were clinically diagnosed with MBS. The cancer detectability using the CB method (62.2%) was significantly higher than that using cytology (37.8%) (p = 0.0344). When CB was combined with biopsy, the rates of cancer detectability (75.6%) and accuracy (81.4%) increased. In eight patients who received surgical therapy, maspin- and p53-immunohistochemistry was applied to the surgical and CB specimens, and cancer cells in both specimens showed positive cytoplasmic and nuclear staining for maspin and nuclear staining for p53. The CB method is, thus, useful for detecting malignancy (UMIN000034707).

Identification of endoscopic predictors of biliary malignancy during digital cholangioscopy.

Biliary brushings and biopsies obtained during endoscopic retrograde cholangiopancreatography (ERCP) have a low sensitivity for the diagnosis of malignant biliary strictures. While cholangioscopic analysis is useful, visual criteria have not yet been defined. The aim of this study was to identify visual criteria for the diagnosis of indeterminate biliary strictures (IDBS). A multicenter study was conducted based on the analysis of cholangioscopic recordings of IBDS. Diagnostic criteria were identified in a study group and verified in a validation group. Four criteria were identified to be associated with malignancy, one negatively ("endobiliary material," odds ratio [OR] 0.62, 95% confidence interval [CI] 0.41-0.92) and three positively ("vascularized villous projections," OR 1.52, 95% CI 1.03-2.24; "twisted or dilated vessels," OR 2.18, 95% CI 1.47-3.24; and "dark color of the mucosa," OR 1.82, 95% CI 1.23-2.70). Between two playbacks, the mean (95% CI) sensitivity of the observer's visual diagnosis increased from 66.1% (60-72) to 73.8% (69-78) (P = 0.004); in the second playback, the kappa value for interobserver agreement ranged between 0.36 (color) and 0.56 (endobiliary material), with a significant improvement (P = 0.0031-0.0001) between the first and second playbacks. Blind assessment by endoscopists not involved in this study had a diagnostic accuracy of 73% (71.4-74.5). The four identified cholangioscopic features are easy to implement in clinical practice and have the potential to increase the level of diagnostic confidence during the workup of IDBS.

Significance of in vitro photodynamic cytodiagnosis with 5-aminolevulinic acid in biliary brush cytology for malignant biliary stricture

BackgroundFor the early diagnosis of malignant biliary stricture due to biliary-pancreatic carcinoma, conventional biliary brush cytology with endoscopic retrograde cholangiopancreatography (ERCP; the conventional method) is not sensitive enough. MethodsTwo hundred nine patients with biliary stricture who were admitted between September 2015 and June 2020 were enrolled in this study. Biliary brush cytology was performed on all patients. Samples were diagnosed independently by an expert pathologist and medical doctor with conventional cytology and photodynamic diagnosis (PDD) with 5-aminolevulinic acid. ResultsThe definitive diagnoses were 49 benign and 160 malignant diseases. The conventional method had a sensitivity of 77.5% (124/160) and specificity of 100% (49/49). The PDD method had a sensitivity of 77.5% (124/160) and specificity of 67.3% (33/49). The conventional method identified 36 malignant diseases as false negatives, while the PDD method enabled successful diagnoses of malignant diseases in 19 of these 36 patients. When PDD was combined with the conventional method, the sensitivity significantly increased to 89.4% (143/160, P = 0.006), and for biliary tract diseases only, the sensitivity increased to 95.6% (88/92, P = 0.001). ConclusionsMalignant biliary stricture can be diagnosed effectively and safely with the in vitro PDD method. The sensitivity could be further increased by combining PDD with the conventional method.

More Endoscopy-Based Brushing Passes Improve the Detection of Malignant Biliary Strictures: A Multicenter Randomized Controlled Trial

Endoscopic biliary brushing is the most common method used for sampling in patients with malignant biliary strictures (MBSs); however, its sensitivity is relatively low. There is still no consensus on endoscopy-based biliary brushing, although brushing 10 times in 1 specimen is routinely performed. This study was designed to compare the sensitivity of brush cytology for 10, 20, or 30 brushing times of a pass in 1 specimen in patients with MBSs. In this multicenter, prospective, randomized controlled study, patients who underwent endoscopic retrograde cholangiopancreatography for suspected MBSs were enrolled. Patients were randomly assigned to receive 10, 20, and 30 brushing times of a pass. The primary outcome was to compare the sensitivity of brush cytology among the 3 groups. Patients were prospectively followed up for 6 months after endoscopic brushing for malignancy diagnosis. A total of 443 patients were enrolled for intention-to-treat analysis (147, 148, and 148 patients in the 10-times, 20-times, and 30-time groups, respectively). The 3 groups were similar in baseline characteristics. The sensitivity of brush cytology was 38%, 47%, and 57% in the 10-times, 20-times, and 30-times groups, respectively, and the 30-times group showed significantly higher sensitivity than the 10-times group (P = 0.001). The multivariate analysis revealed that stricture length and the number of brushing passes were significant factors for the detection of biliary malignancy. No significant differences were observed in procedure-related complications among the 3 groups. Brushing 30 times could increase the diagnostic sensitivity without increasing complications and seems to be preferred for the endoscopic sampling and diagnosis of MBSs (chictr.org.cn, identifier: ChiCTR1800015978).

Systematic review and meta-analysis of percutaneous transluminal forceps biopsy for diagnosing malignant biliary strictures.

To perform a systematic review and meta-analysis to determine the diagnostic performance of percutaneous transluminal forceps biopsy (PTFB) for differentiating malignant from benign biliary stricture. A comprehensive literature search of the PubMed, EMBASE, and Ovid MEDLINE databases was conducted to identify original articles published between January 2001 and January 2021 reporting the diagnostic accuracy of PTFB. A random-effects model was used to summarize the diagnostic odds ratio and other measures of accuracy. Fourteen studies involving 1762 patients met the inclusion criteria and were included in the meta-analysis. The meta-analysis summary estimates of PTFB for diagnosis of malignant biliary strictures were as follows: sensitivity 81% (95% confidence interval [CI], 78-81%); specificity 100% (95% CI, 98-100%); diagnostic odds ratio 85.34 (95% CI, 38.37-189.81). The area under the curve of PTFB was 0.948 in the diagnosis of malignant biliary strictures. The diagnostic sensitivity was higher in intrinsic (85%) than in extrinsic (73%) biliary strictures. The pooled rate of all complications was 10.3% (95% CI, 7.0-14.2%), including a major complication rate of 3.1%. These data demonstrate that PTFB is sensitive and highly specific for diagnosing malignancy in biliary strictures. PTFB should be incorporated into future guidelines for tissue sampling in biliary cancer, especially in cases with failed endoscopic management. • PTFB had a good overall diagnostic performance for differentiating malignant from benign biliary strictures, with a meta-analysis summary estimate of 81% for sensitivity and 100% for specificity. • PTFB had higher sensitivity for cholangiocarcinoma (85%) than for other cancers (73%). • PTFB had a 100% technical success rate and a 10.3% rate for complications, including a 3.1% rate for major complications.

Assessment of different modalities for repeated tissue acquisition in diagnosing malignant biliary strictures: A two-center retrospective study.

Various modalities are applied for pathological diagnosis of malignant biliary strictures (MBS), including brush cytology (BC), forceps biopsy (FB) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). We aimed to assess the value of these modalities in a repeated tissue acquisition process for biliary strictures with initially inconclusive pathological outcomes. Patients who were suspected of having MBS and underwent a BC in two large teaching hospitals were retrospectively included. The sensitivity, specificity, positive and negative predictive values, and accuracy of the initial and repeated BC, FB and EUS-FNA were analyzed. Their performances were compared to determine which modality was superior in repeated tissue acquisition. In total, 476 patients were included. The sensitivity, specificity and accuracy in diagnosing MBS for the initial BC were 30.3%, 100% and 55.0%, respectively. Altogether 39, 27 and 44 patients underwent a repeat BC, FB and EUS-FNA, respectively. The sensitivity for repeated BC, FB and EUS-FNA was 41.2%, 61.1% and 44.4%, respectively, whereas their specificity all reached 100%. When comparing diagnostic accuracy, none of the modalities was superior (74.4% vs 74.1% vs 54.5%, P = 0.173). In the repeated process, one patient who underwent BC and two underwent FB developed mild pancreatitis. Repeated tissue acquisition achieves a conclusive diagnosis of MBS in nearly half patients who have an initially inconclusive cytological diagnosis. None of the tissue acquisition methods is significantly superior in the repeated process.

Liquid Biopsy of Bile based on Targeted Mass Spectrometry for the Diagnosis of Malignant Biliary Strictures.

Bile holds biomarkers of malignant biliary strictures (MBS) but is unsuited for automated analyzers used in routine diagnostic laboratories. Selected reaction monitoring (SRM) is a flexible high‐throughput analytical approach based on targeted mass spectrometry (MS) already implemented in clinical settings. We tested the hypothesis that SRM could be used to quantify cancer biomarkers in human bile. An SRM‐based assay was developed to simultaneously quantify up to 37 peptides from 13 bile proteins in a developmental cohort of 15 patients (MBS, n = 8; benign biliary stricture or obstruction (BBS), n = 7). The most reliable biomarkers were then absolutely quantified by SRM in a verification cohort of 67 patients (MBS, n = 37; BBS, n = 30). The diagnostic performances of single and combined biomarkers were assessed. In the developmental cohort, SRM‐based analysis revealed six protein biomarkers with significantly higher peptide ratios (endogenous vs. standard) in bile from MBS vs. BBS. In the verification cohort, five of these biomarkers proved good diagnostic ability (individual receiver operating characteristic‐area under the receiver operating characteristic curve (ROC‐AUC) up to 0.889, accuracies from 67.8% to 83.1%). Combining bile biomarkers and serum CA19‐9 in 2 panels allowed differentiating MBS from BBS with up to 0.929 ROC‐AUC and 89.8% accuracy. In this study, a newly developed SRM‐based assay proved able to simultaneously quantify multiple biomarkers in bile samples. The combination of bile biomarkers with serum CA19‐9 was highly accurate for the diagnosis of MBS. Liquid biopsy of bile based on targeted MS is eligible to support MBS diagnosis in clinical practice.

S0071 Comparison of Biliary Brush Cytology and Forceps Biopsy in the Diagnosis of Malignant Biliary Strictures

S0071 Comparison of Biliary Brush Cytology and Forceps Biopsy in the Diagnosis of Malignant Biliary Strictures

Comparing Available Cholangioscopes on Diagnosis of Malignant Biliary Strictures

Multiple types of peroral cholangioscopes (POCs) are available for clinical use today. Early cholangioscopes required two operators (DOC), while most

Diagnostic performance of different cholangioscopes in patients with biliary strictures: a systematic review.

Cholangioscopy provides direct intraductual imaging, which can enhance diagnostic efficacy during endoscopic retrograde cholangiopancreatography in patients with biliary strictures. This study aimed to review the diagnostic yield of different cholangioscopes for the diagnosis of malignant biliary stricture (MBS). A comprehensive literature review was performed. Full papers of prospective studies using any type of peroral cholangioscope (POC) were included without language restriction. The primary outcomes were sensitivity, specificity, and accuracy of various POCs to diagnose MBS. Data from 20 published articles, involving 1141 patients, were extracted. Overall sensitivities of POCs for diagnosing MBS were higher for the diagnosis made under visual impression compared with those from cholangioscopy-guided biopsy (67 % - 100 % vs. 38 % - 100 %), whereas the overall specificities were generally high and comparable (73 % - 100 % vs. 75 % - 100 %). Newer video cholangioscopes (digital single-operator POC [digital SOC], direct POC) with the exception of video dual-operator mother - baby POC (video DOC), provided better sensitivity of cholangioscopy-guided biopsy compared with fiberoptic scopes (digital SOC 80 % - 85 %, direct POC 80 % - 100 %, video DOC 38 % - 100 %, and fiberoptic SOC 49 % - 100 %, respectively). Among these video cholangioscopes, the digital SOC provided the highest technical success rate, at 100 %. POCs enhanced the diagnostic yield for diagnosis of MBS. Compared with fiberoptic POCs that only provide good image impression, the digital SOC and direct POC were good at both image impression and cholangioscopy-guided biopsy to diagnose MBS. To ensure high technical success for MBS diagnosis, the digital SOC is a good option.

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.

Value of bile soluble B7[sbnd]H3 for the diagnosis of malignant biliary strictures: Results of a retrospective study

AimsIncreasing evidence has demonstrated that serum soluble B7H3(sB7-H3) is a useful tumor marker for cancer diagnosis and prognostic evaluations. Whether sB7-H3 expressed in the bile is related to the progression of malignant biliary strictures must be clarified. MethodsBile sB7-H3 was obtained via endoscopic retrograde cholangiopancreatography (ERCP) from 323 patients suspected to have malignant biliary strictures and was detected using a B7H3 ELISA kit. Diagnostic value was compared among bile sB7-H3, CA19-9, CA12-5, and CEA and ERCP-based cytological/tissue examination. Additionally, the correlations between the bile sB7-H3 concentration and the clinical characteristics of malignant biliary strictures were studied. ResultsThe bile sB7-H3 levels of patients with malignant biliary strictures were significantly higher than those in patients with benign biliary strictures (P < 0.001). The AUC values of the receiver operating characteristic(ROC) curves for CA19-9, CA12-5 and CEA were 0.764, 0.475 and 0.399, respectively, which were significantly lower than that of sB7-H3 (0.878); the sensitivities of ERCP-based cytological and tissue examinations were 55.7% and 66.4%, respectively, which were far lower than that of bile sB7-H3(81.2%). A high level of sB7-H3 in patients with malignant biliary strictures was found to be correlated with vascular invasion(P < 0.001), lymph node metastasis(P < 0.001), distant metastasis (P < 0.001) and tumor-node-metastasis (TNM) stage(P = 0.01). The overall survival rate of the patients in the high sB7-H3 group was significantly lower than that of the patients in the low sB7-H3 group(P = 0.014). ConclusionsBile sB7-H3 could serve as a valuable biomarker for patients with malignant biliary strictures and high levels of bile sB7-H3 were associated with poor clinical outcomes.