Risk Factors for Perforation During Endoscopic Papillary Large Balloon Dilation and Bile Duct Stone Removal.

BACKGROUND: Stone removal using endoscopic papillary large balloon dilation (EPLBD) is extremely effective. However, limited research exists regarding the risk factors for perforation of the duodenal papilla and bile duct, which may be fatal. AIMS: We aimed to investigate the risk factors for perforation during EPLBD + stone removal. METHODS: We included patients who underwent EPLBD + stone removal at four medical facilities between January 2008 and December 2018. We retrospectively analyzed the risk factors for perforation and their relationship between overdilation and adverse events. Overdilation was defined as a ratio of the balloon diameter to the diameter of the bile duct that exceeded 100%. The diameter of the distal bile duct was measured using the diameter of the intrapancreatic bile duct at a point 10 mm toward the liver from the narrow distal segment on a cholangiogram. RESULTS: We included 310 patients (177 males; median age: 79 years [range: 46-102 years]). Perforation occurred in five patients (1.6%). Multivariate analysis indicated that no surrounding-pancreas (half or less of the circumference of the intrapancreatic bile duct was surrounded by the pancreatic parenchyma) was a significant risk factor (perforation rate: 8.3%, p = 0.011, odds ratio: 12.7 [95% confidence interval: 1.8-90.5]). No significant difference was found between the overdilation and non-overdilation groups regarding the occurrence of pancreatitis, bleeding, and cholangitis. Perforation rate in patients with no surrounding pancreas + overdilation was 16.7% (2/12). Patients with perforation underwent conservative therapy, which improved their conditions. CONCLUSIONS: EPLBD + stone removal should be avoided in patients with no surrounding pancreas. Overdilation is not a risk factor for adverse procedural events; however, it should be limited in patients with surrounding pancreas.

Diagnostic efficacy of white core cutoff lengths obtained by EUS-guided fine-needle biopsy using a novel 22G franseen biopsy needle and sample isolation processing by stereomicroscopy for subepithelial lesions.

OBJECTIVES: The aim of this study is to estimate the cutoff length for stereomicroscopically visible white core (SVWC) required for the pathological diagnosis of subepithelial lesions (SELs) from samples obtained using a novel 22-G Franseen biopsy needle and determine the sensitivity using the SVWC cutoff length. PATIENTS AND METHODS: Thirty patients with SELs requiring pathological diagnoses were included. EUS-guided fine-needle biopsies (EUS-FNBs) were performed using a novel 22G Franseen biopsy needle. SVWC cutoff lengths were measured using sample isolation processing by stereomicroscopy (SIPS). The utility of the calculated SVWC cutoff lengths was measured. RESULTS: The procedural success and SVWC sampling rates were both 100%. The median SVWC length was 14.5 mm. Pathological examinations identified 16 patients with gastrointestinal stromal tumors, 7 with schwannomas, 6 with leiomyomas, and 1 with an ectopic pancreas. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for diagnosing malignancy using EUS-FNB were all 100%. The final diagnostic accuracy was 100%. Regarding the final diagnosis, based on the receiver operating characteristic curves calculated using the SVWC length, the area under the curve was 0.958 (95% confidence interval: 0.897-1.020, P < 0.001) and the cutoff length was 4 mm. The sensitivity of the new SVWC cutoff length was 98.7%. CONCLUSIONS: Diagnostic results of EUS-FNBs using a novel 22-G Franseen biopsy needle were significantly better with SVWC cutoff lengths ≥4 mm. Performing the SIPS procedure with a cutoff value of 4 mm as an index may be especially useful for successful pathological diagnosis of SELs at institutions where rapid on-site evaluation cannot be performed.

On-site stereomicroscope quality evaluations to estimate white core cutoff lengths using EUS-FNA biopsy sampling with 22-gauge needles.

BACKGROUND AND AIMS: Although rapid on-site cytologic evaluation (ROSE) during EUS-guided FNA biopsy (EUS-FNAB) sampling may improve accuracy of pathologic analyses, cytopathologists are not widely available. We calculated the cutoff lengths required for accurate pathologic diagnoses from stereomicroscopically visible white cores (SVWCs) sampled using 22-gauge needles. METHODS: Overall, 118 patients with mediastinal or upper abdominal solid masses requiring pathologic diagnoses were included. EUS-FNAB sampling was performed using 22-gauge needles. SVWCs were isolated and measured using stereomicroscopy, and the utility of calculated cutoff lengths in diagnosis was investigated. RESULTS: The procedure success and SVWC sampling rates were both 100%, and the median SVWC length was 10 mm. Pathologic examination identified 75, 31, and 12 patients with pancreatic neoplasms (PNs), subepithelial lesions (SELs), and other lesions, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for diagnosing malignancy using EUS-FNAB sampling were 93.1%, 100%, 100%, 69.6%, and 94%, respectively. The final diagnostic accuracy in the entire cohort, PNs, and SELs was 92.4%, 90.7%, and 93.5%, respectively. Receiver operating characteristic curves demonstrated the overall SVWC cutoff length to be 11 mm (11 mm for PNs, 3.5 mm for SELs). The overall sensitivity according to SVWC cutoff length was 91.4% (87.6% for PNs, 98.8% for SELs). Compared with cutoff length, multivariate analysis confirmed SVWC length to be a stronger independent factor for tissue diagnosis in both groups. CONCLUSIONS: Diagnosis improved significantly with SVWC cutoff lengths ≥11 mm. This may be a useful index for endoscopists, particularly where ROSE is unavailable. (Clinical trial registration number: UMIN000023013.).

Usefulness of serum lipase for early diagnosis of post-endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is new onset acute pancreatitis after ERCP. This complication is sometimes fatal. As such, PEP should be diagnosed early so that therapeutic interventions can be carried out. Serum lipase (s-Lip) is useful for diagnosing acute pancreatitis. However, its usefulness for diagnosing PEP has not been sufficiently investigated. AIM: This study aimed to retrospectively examine the usefulness of s-Lip for the early diagnosis of PEP. METHODS: We retrospectively examined 4192 patients who underwent ERCP at our two hospitals over the last 5 years. The primary outcomes were a comparison of the areas under the receiver operating characteristic (ROC) curves (AUCs) of s-Lip and serum amylase (s-Amy), s-Lip and s-Amy cutoff values based on the presence or absence of PEP in the early stage after ERCP via ROC curves, and the diagnostic properties [sensitivities, specificities, positive predictive values (PPV), and negative predictive value (NPV)] of these cutoff values for PEP diagnosis. RESULTS: Based on the eligibility and exclusion criteria, 804 cases were registered. Over the entire course, PEP occurred in 78 patients (9.7%). It occurred in the early stage after ERCP in 40 patients (51.3%) and in the late stage after ERCP in 38 patients (48.7%). The AUCs were 0.908 for s-Lip [95% confidence interval (CI): 0.880-0.940, P < 0.001] and 0.880 for s-Amy (95%CI: 0.846-0.915, P < 0.001), indicating both are useful for early diagnosis. By comparing the AUCs, s-Lip was found to be significantly more useful for the early diagnosis of PEP than s-Amy (P = 0.023). The optimal cutoff values calculated from the ROC curves were 342 U/L for s-Lip (sensitivity, 0.859; specificity, 0.867; PPV, 0.405; NPV, 0.981) and 171 U/L for s-Amy (sensitivity, 0.859; specificity, 0.763; PPV, 0.277; NPV, 0.979). CONCLUSION: S-Lip was significantly more useful for the early diagnosis of PEP. Measuring s-Lip after ERCP could help diagnose PEP earlier; hence, therapeutic interventions can be provided earlier.

Endoscopic Balloon Dilation for Benign Bilioenteric Stricture: Outcomes and Factors Affecting Recurrence.

BACKGROUND: Balloon dilation (BD) is a simple, effective procedure for postoperative benign bilioenteric strictures (BBESs). Factors associated with BBES recurrence after endoscopic BD have not been studied adequately. This study examined the outcomes and 1-year recurrence factors in patients with BBES who underwent endoscopic BD. METHODS: Patients who underwent endoscopic BD as an initial treatment between April 2008 and March 2017 were retrospectively assessed. The median time to recurrence of BBES (RBBES) and recurrence factors were evaluated. RESULTS: The study group comprised 55 patients (median age 72 years). The rate of RBBES was 52.7% (29/55), and the median time to RBBES was 2.78 years (95% confidence interval [CI] 1.17-4.40). RBBES was observed in 32.7% (18/55) within 1 year after endoscopic BD. The significant factors associated with recurrence within 1 year, revealed by multivariate analysis, were: postoperative bile leak (p = 0.001; hazard ratio [HR] 10.94; 95% CI 2.47-48.39); BBES onset within 6 months, postoperatively (p = 0.013; HR 6.18; 95% CI 1.46-26.21); no intrahepatic stones (p = 0.049; HR 3.05; 95% CI 1.01-9.22); and remaining balloon waist (p = 0.005; HR 5.71; 95% CI 1.69-19.31). The median time to RBBES was significantly shorter in patients with these recurrence factors (0.88 years vs. not reached, p = 0.004). Patients exhibiting at least two recurrence factors were significantly more likely to experience recurrence (p < 0.001). CONCLUSION: Endoscopic BD is effective for BBES, especially for patients with no recurrence factors. Consideration of endoscopic BD and additional treatment may be necessary for patients with recurrence factors.

A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer.

BACKGROUND: The efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-PTX) plus gemcitabine (GEM) in elderly Japanese patients with pancreatic cancer remain unclear. Therefore, we prospectively investigated the tolerability and efficacy of nab-PTX + GEM in Japanese patients aged ≥ 75 years with non-curatively resectable pancreatic cancer. METHODS: We treated eligible patients (n = 27) with nab-PTX + GEM until disease progression, appearance of adverse events, or withdrawal of consent. The primary endpoints included adverse events as well as dosing- and survival-related parameters. RESULTS: The rates of 2-cycle completion were 48.1% for nab-PTX and 55.6% for GEM; the relative dose intensities for the 7th (median) treatment cycle were 65.1% and 74.1%, respectively, whereas the dose-reduction rates were 81.5% and 48.1%, respectively. Grade 3 or higher hemotoxicity was observed in 14 of 27 subjects (51.9%); moreover, 22% experienced grade ≥ 3 peripheral nerve disorder and 1 patient (3.7%) died owing to chemotherapy-related interstitial pneumonia. The disease control rate was 92.6% (25/27), while the median progression-free and overall survival times were 7 and 10.3 months, respectively. CONCLUSION: The nab-PTX + GEM regimen is as efficacious in elderly patients who meet certain criteria as it is in previously reported non-elderly patients. The regimen is feasible with appropriate dose adjustments and attention to adverse events. TRIAL REGISTRATION: Clinical trial registration number: UMIN000018907.

A case of extrahepatic bile duct cancer with distant metastases showing pathological complete response to treatment combining gemcitabine and cisplatin.

The patient was a 69-year-old female with a chief complaint of yellow staining of her urine. A detailed physical examination and laboratory tests were carried out, and as a result, her condition was diagnosed as unresectable advanced extrahepatic cholangiocarcinoma with liver metastases. Chemotherapy using gemcitabine + cisplatin was initiated, and computed tomography after six cycles revealed that the liver metastases had disappeared, and that a partial response was achieved in the primary tumor. After tan cycles, a pylorus-preserving pancreaticoduodenectomy was performed as conversion surgery, and as a result, a pathological complete response was achieved in the primary tumor. After the primary lesion was resected, we were able to start an adjuvant chemotherapy immediately. Approximately 19 months have passed since the surgery, and the patient is currently alive and recurrence-free. If an improvement of the outcomes of chemotherapy in unresectable advanced biliary tract carcinomas is achieved in the future, there could be an increase in the number of treatment-responsive cases like the one reported in this study. Accumulating a large number of cases successfully treated by conversion surgery, and conducting a detailed analysis of the postoperative course, may help design adequate treatment strategies.

Transpapillary Biliary Cannulation is Difficult in Cases with Large Oral Protrusion of the Duodenal Papilla.

BACKGROUND: Biliary cannulation failure is a major problem during endoscopic retrograde cholangiopancreatography. It remains unclear how duodenal papilla morphology affects biliary cannulation. Therefore, we proposed a new classification system for the duodenal papilla based on oral protrusion pattern (ratio of the length of the oral protrusion to the transverse diameter of the papilla) and papilla pattern. AIMS: To retrospectively compare biliary cannulation results with regard to classification and operator experience. METHODS: We analyzed 589 naïve major duodenal papillae. Our classification system comprised oral protrusion pattern, classified as small (Protrusion-S), regular (Protrusion-R), or large (Protrusion-L), and the papilla pattern, classified as annular (Papilla-A), unstructured (Papilla-U), longitudinal (Papilla-LO), isolated (Papilla-I), or gyrus (Papilla-G). Intra-evaluator concordance and the results of biliary cannulation were analyzed. RESULTS: The following oral protrusion pattern classifications were observed: Protrusion-S, 11.7%; Protrusion-R, 77.9%; and Protrusion-L, 10.4%. The following papilla patterns were observed: Papilla-A, 67.1%; Papilla-U, 7.0%; Papilla-LO, 7.5%; Papilla-I, 1.2%; Papilla-G, 15.6%; and unclassified, 1.7%. Intra-evaluator concordance value (Fleiss kappa) was 0.788 for oral protrusion pattern and 0.750 for papilla pattern. A logistic regression analysis of cannulations performed by an experienced endoscopist identified Protrusion-L as a significant risk factor for difficult cannulation (odds ratio 2.956; 95% confidence interval 1.115-7.84; p = 0.029). Multivariate analysis confirmed Protrusion-L as an independent risk factor for difficult biliary cannulation (odds ratio 3.772; 95% confidence interval 1.359-10.464; p = 0.011). CONCLUSIONS: We propose a new general classification system for the duodenal papilla. Protrusion-L is a significant risk factor for difficult biliary duct cannulation.

Analysis of the diagnostic yield of endoscopic ultrasonography-guided fine-needle aspiration in patients with a suspected pancreatic malignanc

Objectives: to determine the diagnostic yield of endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) for suspected pancreatic malignancy. As well as to identify factors that affect the incidence of false-negative cases and evaluate the value of repeated EUS-FNA in patients with inconclusive results. Methods: we retrospectively evaluated the data of patients who underwent EUS-FNA due to a suspected pancreatic malignancy in our hospital from January 2015 to December 2016. Results: a total of 194 EUS-FNA procedures performed and 175 cases were analyzed. The overall sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were 83.4% (151/181), 100% (13/13), 100% (151/151), 30.2% (13/43), and 84.5% (164/194), respectively. The combination of cytological and histological examination significantly increased the diagnostic performance compared to either method alone. The diagnostic sensitivity in metastatic tumors was significantly lower than that for adenocarcinoma. EUS-FNA performed using standard needles combined with the "slow-pull" technique had a lower sensitivity than other methods. According to the multivariate analysis, neither the combination of needle type and suction technique nor final diagnosis were independent factors that affected the diagnostic sensitivity. The sensitivity of repeated EUS-FNA was 50.0% (8/16). Definitive results after a repeated puncture were more likely for pancreatic body and tail masses, heterogeneous lesions and poorly demarcated lesions. However, the difference was not significant. Conclusions: EUS-FNA was accurate for the evaluation of a suspected pancreatic malignancy. Metastatic tumors and the use of a standard needle in combination with the slow-pull technique may increase the incidence of false-negative results. Repeated EUS-FNA has limited value but should be considered for selected cases where the suspicion of malignancy persists

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Analysis of the diagnostic yield of endoscopic ultrasonography-guided fine-needle aspiration in patients with a suspected pancreatic malignancy.

OBJECTIVES: to determine the diagnostic yield of endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) for suspected pancreatic malignancy. As well as to identify factors that affect the incidence of false-negative cases and evaluate the value of repeated EUS-FNA in patients with inconclusive results. METHODS: we retrospectively evaluated the data of patients who underwent EUS-FNA due to a suspected pancreatic malignancy in our hospital from January 2015 to December 2016. RESULTS: a total of 194 EUS-FNA procedures performed and 175 cases were analyzed. The overall sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were 83.4% (151/181), 100% (13/13), 100% (151/151), 30.2% (13/43), and 84.5% (164/194), respectively. The combination of cytological and histological examination significantly increased the diagnostic performance compared to either method alone. The diagnostic sensitivity in metastatic tumors was significantly lower than that for adenocarcinoma. EUS-FNA performed using standard needles combined with the "slow-pull" technique had a lower sensitivity than other methods. According to the multivariate analysis, neither the combination of needle type and suction technique nor final diagnosis were independent factors that affected the diagnostic sensitivity. The sensitivity of repeated EUS-FNA was 50.0% (8/16). Definitive results after a repeated puncture were more likely for pancreatic body and tail masses, heterogeneous lesions and poorly demarcated lesions. However, the difference was not significant. CONCLUSIONS: EUS-FNA was accurate for the evaluation of a suspected pancreatic malignancy. Metastatic tumors and the use of a standard needle in combination with the slow-pull technique may increase the incidence of false-negative results. Repeated EUS-FNA has limited value but should be considered for selected cases where the suspicion of malignancy persists.

Influence of cholangitis after preoperative endoscopic biliary drainage on postoperative pancreatic fistula in patients with middle and lower malignant biliary strictures.

BACKGROUND AND AIM: Preoperative cholangitis after preoperative drainage has been reported to increase postoperative complications, particularly pancreatic fistula. We therefore examined the effects of cholangitis after preoperative endoscopic biliary drainage (EBD) on postoperative pancreatic fistula in patients with middle and lower malignant biliary strictures. METHODS: The study group comprised 102 patients who underwent EBD among patients who underwent surgery. RESULTS: Of the 102 patients, 33 (32%) had postoperative pancreatic fistulas, and 56 (55%) had preoperative cholangitis after preoperative drainage. Analysis of risk factors for preoperative cholangitis showed that a total bilirubin level of 2.9 mg/dL or higher (hazard ratio [HR], 2.95; 95% confidence interval [CI], 1.223-7.130; P = 0.016) and a surgical waiting time of 29 days or longer (HR, 4.23; 95% CI, 1.681-10.637; P = 0.02) were independent risk factors for cholangitis. Patients with preoperative cholangitis had a significantly higher incidence of pancreatic fistula than did patients without preoperative cholangitis (78.8 vs 21.2%; P = 0.001). Patients with biliary cancer had a significantly higher incidence of pancreatic fistula than did those with pancreatic cancer (72.7 vs 27.2%; P = 0.005). Multivariate analysis showed that preoperative cholangitis (HR, 4.8; 95% CI, 1.785-12.992; P = 0.001) and biliary cancer (HR, 3.5; 95% CI, 1.335-8.942; P = 0.006) were significant independent risk factors for postoperative pancreatic fistula. CONCLUSION: Prevention of preoperative cholangitis, a risk factor for postoperative pancreatic fistula, is likely to decrease the incidence of postoperative pancreatic fistula.

Randomized crossover trial comparing EUS-guided fine-needle aspiration with EUS-guided fine-needle biopsy for gastric subepithelial tumors.

AIM: The purpose of this study is to compare the diagnostic yield of endoscopic ultrasound (EUS)-guided fine-needle aspiration (EUS-FNA) and EUS-guided fine-needle biopsy (EUS-FNB) for gastric subepithelial tumors (SET). METHODS: Patients diagnosed SET derived from fourth layer of the stomach were prospectively enrolled and randomly assigned to undergo both EUS-FNA using standard needle and EUS-FNB using a core biopsy needle alternatively to the same lesion a total of four times per session. The specimen was carefully examined for the presence of a macroscopic visible core, appearing as threadlike yellowish or bloody pieces of tissue and blinded histocytologic analyses were conducted. For spindle cell lesions by hematoxylin and eosin staining (H&E) on histologic evaluation, immunohistochemical staining was performed in all cases to confirm the pathological diagnosis. RESULTS: A total of 23 patients were enrolled and underwent paired EUS-FNA and -FNB sampling. The diagnostic rate due to immunohistochemical staining was 73.9% and 91.3%, respectively (P = .120). The rate of obtaining specimens with a macroscopic yellowish core and only a bloody core among the tissue specimens were respectively 43.5% and 52.2% for EUS-FNA and 69.6% and 30.4% for EUS-FNB. The diagnostic rate for a yellowish core (84.6%) and a bloody core (84.2%, P = .971) did not differ significantly. CONCLUSION: Both techniques were equivalently safe and successful in terms of a high diagnostic yield for gastric SET. And the tissue that can be immunohistochemically stained is present even in the specimens that appear to be a macroscopically bloody core.

Therapeutic peroral direct cholangioscopy using a single balloon enteroscope in patients with Roux-en-Y anastomosis (with videos).

BACKGROUND: Peroral cholangioscopic lithotripsy is a useful procedure in patients with a normal gastrointestinal anatomy who have difficult-to-treat stones. We evaluated the usefulness of peroral direct cholangioscopy (PDCS) using single-balloon enteroscope (SBE) in patients with difficult-to-treat stones who had undergone Roux-en-Y reconstruction. METHODS: Among 118 patients (169 sessions) who underwent SBE-assisted endoscopic retrograde cholangiopancreatography to treat biliary stones after Roux-en-Y reconstruction, patients in whom it was difficult to remove biliary stones via a transpapillary or transanastomotic approach and difficult to switch to ultra-slim endoscope, were retrospectively enrolled. The biliary insertion success rate, procedure success rate, procedure time, and procedural complications were assessed. The SBE was inserted into the bile-duct, first using a free-hand technique, second using a guide wire, and third using the large balloon anchoring and deflation (LBAD) technique. RESULTS: A total of 11 patients (14 sessions) were enrolled in this study. The biliary insertion success rate was 100%. Bile-duct insertion was performed using a free-hand technique in 4 sessions, a guide wire in 3 sessions (rendezvous technique, 2 sessions), and the LBAD technique in 7 sessions. The procedure success rate was 86% in first session, and 100% in second session. The median procedure time was 81 min (range 49-137). The median procedure time in the bile-duct was 21.5 min (range 6-60). Mild pancreatitis occurred as a complication in one patient. The median follow-up was 528 days (range 282-764). No patient had stone recurrence. CONCLUSIONS: PDCS using SBE is a useful procedure in patients with Roux-en-Y reconstruction. The LBAD technique is an useful technique of inserting SBE into the bile-duct.

Endoscopic ultrasonography diagnosis of subepithelial lesions.

Using endoscopic ultrasonography (EUS), it is practicable to diagnose subepithelial lesions (SEL) with originating layer, echo level, and internal echo pattern etc. Lipoma, lymphangioma, and cyst have characteristic features; therefore, there is no need for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). Ectopic pancreas and glomus tumors, which originate from the third and fourth layers, are frequently seen in the antrum. However, ectopic pancreas located in the fundus or body is large and originates from the third and fourth layers (thickening of fourth layer). Each subepithelial lesion has characteristic findings. However, imaging differentiation of tumors originating from the fourth layer is very difficult, even if contrast echo is used. Therefore, EUS-FNA should be done in these tumors, but the diagnostic yield for small lesions is not sufficient for clinical demands. Generally, those tumors, including small ones, should be first followed up in 6 months, then yearly follow up in cases of no significant change in size and features. When those tumors become larger than 1-2 cm, EUS-FNA is recommended. Furthermore, unusual SEL and SEL with malignant findings such as nodular, heterogeneous, anechoic area, and ulceration indicate EUS-FNA. Cap-attached forward-viewing echoendoscope is very helpful for EUS-FNA of small SEL.