Clinical Outcomes of Secondary Duodenal Self-Expandable Metallic Stenting for Duodenal Stent Dysfunction in Patients with Malignant Duodenal Obstruction: A Retrospective Multicenter Study.

Background/Aims: Malignant duodenal obstruction has become more common with the development of palliative therapies.The outcomes of endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) are comparable to those of surgical gastrojejunostomy or duodenal stenting. However, EUS-GJ is technically challenging. Duodenal self-expandable metallic stent (SEMS) placement is popular; however, obstructions are common. Duodenal SEMS obstruction can be managed with the insertion of a second SEMS in a stent-in-stent manner. Therefore, we aimed to analyze the clinical outcomes of secondary duodenal SEMS placement in patients with malignant duodenal obstruction. Methods: We retrospectively analyzed the data of patients who underwent secondary duodenal stent insertion for duodenal stent dysfunction between January 2016 and December 2021. The primary outcome was stent patency. The secondary outcomes were clinical success, factors associated with dysfunction, patient survival, and adverse events. Results: A total of 109 patients were included. The mean age was 64.4±11.2 years, and 63 patients (57.8%) were male. Ninety-two patients (84.4%) had pancreaticobiliary cancer. Clinical success was achieved in 94 cases (86.2%). Twenty-three patients experienced stent dysfunction with 231 days of median stent patency (95% confidence interval [CI], 169 to not available). After a multivariable Cox hazard analysis of stent patency, the Eastern Cooperative Oncology Group performance status (hazard ratio [HR], 2.13; 95% CI, 1.20 to 3.81; p=0.010) and the first stent patency ≥6 months (HR, 0.33; 95% CI, 0.11 to 0.95; p=0.050) remained significant associated factors. Adverse events occurred in five patients (4.6%). Conclusions: Secondary duodenal stent insertion is a viable option for first duodenal stent obstruction. Further comparative studies involving surgery or EUS-GJ for obstructed duodenal stents are warranted.

Angiotensin Receptor Blockers and the Risk of Suspected Drug-Induced Liver Injury: A Retrospective Cohort Study Using Electronic Health Record-Based Common Data Model in South Korea.

INTRODUCTION: Angiotensin receptor blockers are widely used antihypertensive drugs in South Korea. In 2021, the Korea Ministry of Food and Drug Safety acknowledged the need for national compensation for a drug-induced liver injury (DILI) after azilsartan use. However, little is known regarding the association between angiotensin receptor blockers and DILI. OBJECTIVE: We conducted a retrospective cohort study in incident users of angiotensin receptor blockers from a common data model database (1 January, 2017-31 December, 2021) to compare the risk of DILI among specific angiotensin receptor blockers against valsartan. METHODS: Patients were assigned to treatment groups at cohort entry based on prescribed angiotensin receptor blockers. Drug-induced liver injury was operationally defined using the International DILI Expert Working Group criteria. Cox regression analyses were conducted to derive hazard ratios and the inverse probability of treatment weighting method was applied. All analyses were performed using R. RESULTS: In total, 229,881 angiotensin receptor blocker users from 20 university hospitals were included. Crude DILI incidence ranged from 15.6 to 82.8 per 1000 person-years in treatment groups, most were cholestatic and of mild severity. Overall, the risk of DILI was significantly lower in olmesartan users than in valsartan users (hazard ratio: 0.73 [95% confidence interval 0.55-0.96]). In monotherapy patients, the risk was significantly higher in azilsartan users than in valsartan users (hazard ratio: 6.55 [95% confidence interval 5.28-8.12]). CONCLUSIONS: We found a significantly higher risk of suspected DILI in patients receiving azilsartan monotherapy compared with valsartan monotherapy. Our findings emphasize the utility of real-world evidence in advancing our understanding of adverse drug reactions in clinical practice.

Characteristics of Early Pancreatic Cancer: Comparison between Stage 1A and Stage 1B Pancreatic Cancer in Multicenter Clinical Data Warehouse Study.

BACKGROUND: Little is known about the characteristics of early pancreatic cancer. We aimed to identify the characteristics, clues for early detection, and prognostic factors for early pancreatic cancer by analyzing a large number of patients with stage 1 pancreatic cancer. METHODS: A clinical data warehouse that includes databases of all the medical records of eight academic institutions was used to select and analyze patients with pancreatic cancer that had been diagnosed from January 2010 to May 2023. RESULTS: In total, 257 stage 1 pancreatic cancer patients were included. There were 134 men (52%), and the average age was 67.2 ± 9.9 years. Compared to patients with stage 1B pancreatic cancer (2-4 cm), patients with stage 1A pancreatic cancer (≤2 cm) had more tumors in the body and tail than in the head (p = 0.028), more new-onset diabetes and less old diabetes (p = 0.010), less jaundice (p = 0.020), more follow-up of IPMN (intraductal papillary mucinous neoplasm, p = 0.029), and more histories of acute pancreatitis (p = 0.013). The pathological findings showed that stage 1A pancreatic cancer involved more IPMNs (p < 0.001) and lower pancreatic intraepithelial neoplasia (p = 0.004). IPMN was present in all 13 pancreatic tumors that were smaller than 1 cm. In multivariate analysis, positive resection margin (odds ratio [OR] 1.536, p = 0.040), venous invasion (OR 1.710, p = 0.010), and perineural invasion (OR 1.968, p = 0.002) were found to be risk factors affecting disease-free survival, while old diabetes (odds ratio [OS] 1.981, p = 0.003) and perineural invasion (OR 2.270, p = 0.003) were found to be risk factors affecting overall survival. CONCLUSIONS: IPMN is closely associated with early pancreatic cancer and may provide an opportunity for early detection. The presence of perineural invasion was a crucial prognostic factor for both overall and disease-free survival in patients with stage 1 pancreatic cancer.

Impact of the Supra-papilla Method on Patency in Distal Malignant Biliary Obstruction: A Multicenter Randomized Controlled Trial.

BACKGROUND: /aims: Placement of a self-expandable metal stent (SEMS) across the duodenal major papilla carries a risk of duodenobiliary reflux (DBR). The supra-papilla method of stenting may reduce DBR and improve stent patency compared to the trans-papilla method. This study aimed to compare the clinical outcomes between the supra-papilla and trans-papilla methods for distal malignant biliary obstruction (DMBO). METHODS: Between January 2021 and January 2023, consecutive patients with DMBO from six centers in Korea were randomly assigned to either the supra-papilla or trans-papilla method arm in a 1:1 ratio. The primary outcome was the duration of stent patency, and secondary outcomes included the cause of stent dysfunction, adverse events, and overall survival rate. RESULTS: A total of 84 patients were equally assigned to each group. The most common cause of DMBO was pancreatic cancer (n=50, 59.5%), followed by bile duct (n=20, 23.8%), gallbladder (n=11, 13.1%), and other cancers (n=3, 3.6%). Stent patency was significantly longer in the supra-papilla group (median [95% confidence interval], 369 [289-497] vs. 154 [78-361] days; P < 0.01). Development of DBR was significantly lower in the supra-papilla group (9.4% vs 40.8%, P < 0.01). Adverse events and overall survival rate were not significantly different between the two groups. CONCLUSIONS: The placement of SEMS using the supra-papilla method resulted in a significantly longer duration of stent patency. It is advisable to place the SEMS using the supra-papilla method in DMBO. Further studies with a larger number of patients are required to validate the benefits of the supra-papilla method.

Clinical implications and perspectives of portal venous circulating tumor cells in pancreatic cancer.

Despite recent improvements in the diagnosis and treatment of pancreatic cancer (PC), clinical outcomes remain dismal. Moreover, there are no effective prognostic or predictive biomarkers or options beyond carbohydrate antigen 19-9 for personalized and precise treatment. Circulating tumor cells (CTCs), as a member of the liquid biopsy family, could be a promising biomarker; however, the rarity of CTCs in peripheral venous blood limits their clinical use. Because the first venous drainage of PC is portal circulation, the portal vein can be a more suitable location for the detection of CTCs. Endoscopic ultrasound-guided portal venous sampling of CTCs is both feasible and safe. Several studies have suggested that the detection rate and number of CTCs may be higher in the portal blood than in the peripheral blood. CTC counts in the portal blood are highly associated with hepatic metastasis, recurrence after surgery, and survival. The phenotypic and genotypic properties measured in the captured portal CTCs can help us to understand tumor heterogeneity and predict the prognosis of PC. Small sample sizes and heterogeneous CTC detection methods limit the studies to date. Therefore, a large number of prospective studies are needed to corroborate portal CTCs as a valid biomarker in PC.

Long-term clinical outcomes of a fully covered self-expandable metal stent for refractory pancreatic strictures in symptomatic chronic pancreatitis: An 11-year follow-up study.

BACKGROUND AND AIMS: A fully covered self-expandable metal stent (FCSEMS) has recently been applied in the management of chronic pancreatitis patients with pancreatic strictures. However, related long-term effects remain unclear. This study aimed to evaluate the long-term outcomes of FCSEMS placement in chronic pancreatitis patients with refractory strictures. METHOD: We retrospectively reviewed our database for patients undergoing FCSEMS placement for refractory pancreatic strictures between September 2008 and December 2010. The main outcomes were technical, radiological, and clinical success, as well as recurrence and adverse events. RESULTS: A total of 35 patients were included. Technical success was achieved in all patients. The median FCSEMS indwelling time was 3.2 months (interquartile range [IQR], 3.0-4.9 months). Radiological success was achieved in all patients (complete, n = 2; partial, n = 33). Clinical success was achieved in 29 patients (82.9%; complete analgesic cessation, n = 19; analgesic reduction >50%, n = 11). During the median follow-up of 136 months, (IQR, 85.8-145.5 months), eight patients (22.9%) experienced recurrence. The median interval from stent removal to recurrence was 24.9 months (IQR, 11.3-30.3 months). Biliary obstruction, an early adverse event, occurred in two patients (5.7%); the late adverse event stent-induced de novo stricture was observed in 17 patients (48.6%). CONCLUSIONS: Our findings suggest that an FCSEMS is effective for relieving refractory strictures in chronic pancreatitis. However, FCSEMSs were associated with stent-induced de novo strictures in nearly half of the patients. Prospective studies are required to further evaluate the long-term efficacy and safety of FCSEMSs in chronic pancreatitis.

Comparison of EUS-guided ablation and surgical resection for nonfunctioning small pancreatic neuroendocrine tumors: a propensity score-matching study.

BACKGROUND AND AIMS: Treatment strategies for small pancreatic neuroendocrine tumors (PNETs) <2 cm in size are still under debate. The feasibility and safety of EUS-guided ethanol ablation (EUS-EA) have been demonstrated. However, sample sizes in previous studies were small with no comparative studies on surgery. Therefore, we aimed to compare the safety and long-term outcomes of EUS-EA with those of surgery for the management of nonfunctioning small PNETs. METHODS: We retrospectively reviewed patients with PNETs who were managed by EUS-EA (from 2011 to 2018) and surgery (from 2000 to 2018) at Asan Medical Center. Propensity score matching (PSM) was performed to increase comparability. The primary outcome was early and late major adverse events (Clavien-Dindo grade ≥III) after treatment. Secondary outcomes were 10-year overall (OS) and disease-specific survival (DSS) rates, length of hospital stay, and development of endocrine pancreatic insufficiency. RESULTS: Of all patients, 97 and 188 patients were included in the EUS-EA and surgery groups, respectively. PSM created 89 matched pairs. EUS-EA was associated with a significantly lower rate of early major adverse events (0% vs 11.2%, P = .003). Late major adverse events occurred more frequently after surgery, with no significant difference between groups (3.4% vs 10.1%, P = .07). Both treatment modalities showed comparable 10-year OS and DSS rates. The length of hospital stay was significantly shorter in the EUS-EA group (4 days vs 14.1 days, P < .001), and endocrine pancreatic insufficiency was less common after EUS-EA than after surgery (33.3% vs 48.6%, P = .121). CONCLUSIONS: EUS-EA had fewer adverse events and a shorter hospital stay with similar OS and DSS rates compared with surgery, suggesting that EUS-EA may be a preferred alternative to surgical resection in selected patients with nonfunctioning small PNETs.

Gastric Perforation Encountered during Duodenal Stent Insertion.

Gastric outlet obstruction is a major symptom in patients with advanced pancreatic cancer. Endoscopic intervention is often challenging in severe strictures because the guidewire cannot pass beyond the stricture. Sometimes, the air itself cannot pass beyond the stricture, which can result in a severely distended stomach. Such a stomach is vulnerable to excessive air insertion or mechanical stress during endoscopic procedures, and endoscopists may encounter a higher rate of complications. Gastric perforation is rare but could be fatal. However, endoscopic management can show a favorable result if the perforation is noticed early. The authors report a case of the perforation of a gastric tear during duodenal stent insertion in a patient with a gastric outlet obstruction.

YouTube as a source of information on endoscopic retrograde cholangiopancreatography.

Endoscopic retrograde cholangiopancreatography (ERCP) carries a higher risk of adverse events than standard endoscopy. Internet media platforms such as YouTube has emerged as a medical information source. Therefore, study aimed to identify whether YouTube videos provide appropriate information on ERCP to the general population. The YouTube search was performed using the terms "endoscopic retrograde cholangiopancreatography" and "ERCP". The top 50 results of both searches, sorted by relevance and view count, were collected. After filtering according to a set of inclusion and exclusion criteria, a total of 26 videos were eligible for the final analysis. For quality assessment, we created a scoring system called ERCP Data Quality score (E-DQS), based on a colonoscopy education video available on the American Society of Gastrointestinal Endoscopy website. Healthcare professionals uploaded 14 (53.8%) videos, and 10 (38.6%) uploaded by medical websites. Only one video was uploaded by a layperson and one by a TV channel. The overall median E-DQS score for enrolled videos was 6.5 out of 20. The majority of videos did not describe the unique features of ERCP. Only 50% of videos informed viewers that patients would be irradiated and only six videos described at least one adverse event related to ERCP. ERCP videos on YouTube provide inadequate information regarding ERCP. Considering the unique characteristics of this procedure, professionals and academic societies need to be vigilant and proactive in producing and promoting high-quality videos.

Gallstone Is Associated with Metabolic Factors and Exercise in Korea.

Gallstone is a common health problem. Cholesterol stone accounts for 90% of stones in the United States and Europe, but East Asia has a high proportion of pigment stone. The aim of this study was to determine the relationship between modifiable metabolic factors and gallstone in a region with a high prevalence of pigment stone. Among 3159 participants who underwent health screening at Ulsan University Hospital from March 2014 to June 2019, 178 patients were diagnosed with gallstone using abdominal ultrasonography; 2860 participants were selected as a control group. Demographic and laboratory data, and a medical questionnaire were obtained. Hypertension and diabetes mellitus were more prevalent in the gallstone group. Age, waist circumference, systolic blood pressure (SBP) ≥ 140 mmHg, fasting blood glucose, HbA1c ≥ 6.5%, visceral fat index, normal-attenuated muscle area index, and engaging in vigorous exercise for ≥2 days per week were associated with gallstone by univariate analysis. Through multivariate logistic regression analysis, HbA1c ≥ 6.5% (odds ratio (OR) 1.98, 95% confidence interval (CI) 1.31-2.98), and 2 or more days of vigorous exercise per week (OR 0.66, 95% CI 0.45-0.95) remained significant. The association persisted after adjusted analysis for age and sex. HbA1c ≥ 6.5% were positively associated with the gallstone. Vigorous exercise for at least 2 days weekly may be related to a lower risk of gallstone formation.

Impact of 5-Year Endoscopic Surveillance Intervals with Biopsy following Endoscopic Papillectomy for Ampullary Adenoma.

Background: Endoscopic snare papillectomy (ESP) has been established as a safe and effective treatment for ampullary adenomas. However, little is known about the optimal post-procedure follow-up period and the role of routine endoscopic surveillance biopsy following ESP. We aimed to evaluate patient adherence to a 5-year endoscopic surveillance and routine biopsy protocol after ESP of ampullary adenoma. Methods: We reviewed our prospectively collected database (n = 98), all members of which underwent ESP for ampullary lesions from January 2011 to December 2016, for the evaluation of long-term outcomes. The primary outcome was the rate of patient adherence to 5-year endoscopic surveillance following ESP. The secondary outcomes were the diagnostic yield of routine endoscopic biopsy, recurrence rate, and adverse events after endoscopic surveillance in the 5-year follow-up (3-month, 6-month, and every 1 year). Results: A total of 19 patients (19.4%) experienced recurrence during follow-up, all of these patients experienced recurrence within 3 years of the procedure (median 217 days, range 69-1083). The adherence rate for patients with sporadic ampullary adenoma were 100%, 93.5%, and 33.6% at 1, 3, and 5 years after ESP, respectively. The diagnostic yield of routine endoscopic biopsy without macroscopic abnormality was 0.54%. Pancreatitis occurred in four patients (4%, 3 mild, 1 moderate) after surveillance endoscopic biopsy without macroscopic abnormality. Conclusions: Given the low 5-year adherence rate and diagnostic yield of routine endoscopic biopsy with risk of pancreatitis, optimal surveillance intervals according to risk stratification (low grade vs. high grade adenoma/intramucosal adenocarcinoma) may be required to improve patient adherence, and routine biopsy without macroscopic abnormality may not be recommended.

Prognosis and Clinical Characteristics of Patients with Pancreatic Ductal Adenocarcinoma Diagnosed by Endoscopic Ultrasonography but Indeterminate on Computed Tomography.

Background/Aims: Endoscopic ultrasonography (EUS) provides high-resolution images and is superior to computed tomography (CT) scan in diagnosing small pancreatic ductal adenocarcinoma (PDAC). As a result, the use of EUS for early detection of PDAC has attracted attention. This study aimed to identify the clinical and radiological characteristics of patients with PDAC diagnosed by EUS but not found on CT scan. Methods: The medical records of patients diagnosed with PDAC at 12 tertiary referral centers in Korea from January 2003 to April 2019 were reviewed. This study included patients with pancreatic masses not clearly observed on CT scan but identified on EUS. The clinical characteristics and radiological features of the patients were analyzed, and survival analysis was performed. Results: A total of 83 patients were enrolled. The most common abnormal CT findings other than a definite mass was pancreatic duct dilatation, which was identified in 61 patients (73.5%). All but four patients underwent surgery. The final pathologic stages were as follows: IA (n=31, 39.2%), IB (n=8, 10.1%), IIA (n=20, 25.3%), IIB (n=17, 21.5%), III (n=2, 2.5%), and IV (n=1, 1.4%). The 5-year survival rate of these patients was 50.6% (95% confidence interval, 38.8% to 66.7%). Elevated liver function testing and R1 resection emerged as significant predictors of mortality in the multivariable Cox regression analysis. Conclusions: This multicenter study demonstrated favorable long-term prognosis in patients with PDAC diagnosed by EUS but indeterminate on CT scan. EUS should be considered for patients with suspected PDAC but indeterminate on CT scan.

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

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

Clinical utility of directional eFLOW compared with contrast-enhanced harmonic endoscopic ultrasound for assessing the vascularity of pancreatic and peripancreatic masses.

BACKGROUND: Contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) can be used for the differential diagnosis of pancreatic lesions by evaluating microvascular circulation and patterns of contrast enhancement. However, routine use of CEH-EUS is limited by its high cost, the lack of contrast agent availability and the absence of expertise with this technique. Directional eFLOW (D-eFLOW) (Aloka Co., Ltd., Tokyo, Japan) was introduced as a new high-definition modality that detects blood flow in microvessels. Because it uses built-in functions, it entails no additional cost and reduces time for examination. The present study compared the usefulness of D-eFLOW and CEH-EUS for differential diagnosis of pancreatic and peripancreatic lesions. METHODS: This retrospective study analyzed 130 patients who underwent EUS and D-eFLOW examinations from January 2016 to March 2020 to evaluate pancreatic and peripancreatic masses. RESULTS: All 130 patients underwent D-eFLOW and CEH-EUS examinations. Histological diagnoses were confirmed in 130 patients by EUS-FNA and/or surgery. D-eFLOW and CEH-EUS showed good correlation in evaluating the vascularity of pancreatic and peripancreatic tumors (Fisher's exact test, p < 0.05). CONCLUSIONS: In evaluating the characteristics of tumorous lesions, vascularity detected by D-eFLOW showed good correlation with enhancement patterns of CEH-EUS. D-eFLOW can be considered a good alternative to CEH-EUS in diagnosing pancreatic and peripancreatic masses.

Macroscopic on-site evaluation after EUS-guided fine needle biopsy may replace rapid on-site evaluation.

BACKGROUND AND OBJECTIVES: Rapid on-site cytologic evaluation (ROSE) increases the diagnostic yield of EUS-FNA. However, ROSE requires the presence of a cytopathologist and additional cost and time for slide staining and interpretation. Macroscopic on-site examination (MOSE) was recently introduced as an alternative to ROSE and showed high accuracy for the use in pathologic diagnosis. We evaluated the efficacy of MOSE in terms of tissue acquisition and diagnostic accuracy for abdominal lesions. METHODS: We analyzed consecutive patients included who underwent EUS-guided fine needle biopsy (FNB) between January 2019 and November 2019. All procedures were done by dry suction using a 22G needle. Obtained specimens were expelled onto filter papers and evaluated by MOSE. Needle pass was done until the acquisition of satisfactory whitish macroscopic visible core or bloody tissue granules. The primary outcomes were successful tissue acquisition and accuracy for pathologic diagnosis. RESULTS: In 75 patients (male, 52%; median age: 62 years), the pancreas was the most commonly targeted organ (81.4%) and the median target diameter was 25 mm. The median number of needle passes was 2.0 (range, 2-5). Successful targeting of the lesion was achieved in 75 patients (100%) and overall accuracy was 97.3%. There were no procedure-related adverse events. CONCLUSIONS: MOSE was effective for complementing EUS-FNB by ensuring the adequate acquisition of biopsy specimens with a minimal number of needle passes while providing a critically high diagnostic accuracy. MOSE seems to be a viable alternative to ROSE in select clinical situations.

Feasibility and Safety of Endoluminal Radiofrequency Ablation as a Rescue Treatment for Bilateral Metal Stent Obstruction Due to Tumor Ingrowth in the Hilum: A Pilot Study.

Background. Radiofrequency ablation (RFA) is a palliative method known for its application in the endoscopic treatment of malignant bile duct obstruction. It may be a useful rescue method for metal stent malfunction caused by tumor ingrowth. This study aimed to examine the feasibility and safety of endoluminal RFA for occluded bilateral hilar metal stents due to tumor ingrowth in patients with malignant hilar bile duct obstruction. Methods: From March 2016 to June 2018, 11 patients with unresectable malignant hilar bile duct stricture with occluded bilateral hilar metal stents due to tumor ingrowth were enrolled. Endoluminal RFA was performed through a novel temperature-controlled catheter at a setting of 7 W power for 120 s with a target temperature of 80 °C via endoscopic retrograde cholangiopancreatography (ERCP). The patients' demographics, clinical outcomes, and adverse events were investigated. Results: The median age was 64 (interquartile range, 54-72) years. All RFA procedures were successful. Clinical success was achieved in eight patients (72.7%). During the follow-up, eight patients (72.7%) showed stent dysfunction, and the median patency after RFA was 50 days (95% confidence interval (CI): 34-not available (NA)). All stent dysfunctions were successfully managed with ERCP. Ten patients died, and the median overall survival was 289 days (95% CI, 107-NA) from RFA to death. There was one case of mild abdominal pain after the procedure without serious adverse events. Conclusions: As a rescue therapy for occluded bilateral hilar metal stents due to tumor ingrowth, endoluminal RFA seemed to be safe and useful in selected patients.

A comparison between 25-gauge and 22-gauge Franseen needles for endoscopic ultrasound-guided sampling of pancreatic and peripancreatic masses: a randomized non-inferiority study.

BACKGROUND: Endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) and fine-needle biopsy (FNB) are the current standard of care for sampling pancreatic and peripancreatic masses. Recently, a 22G EUS-FNB needle with Franseen geometry was developed, and this device was also introduced in a 25G platform. We compared the performance of the 25G and 22G Franseen needles for EUS-guided sampling of pancreatic and peripancreatic solid masses. METHODS: We conducted a parallel-group randomized non-inferiority trial at a tertiary-care center from November 2018 to May 2019. The primary outcome was the quality of the histologic core assessed using the Gerke score. The optimal histologic core is indicated by a Gerke score of 4 or 5, which enables optimal histologic interpretation. The overall diagnostic accuracy and adverse event rate were also evaluated. RESULTS: 140 patients were enrolled and randomized (1:1) to the 25G and 22G groups. Tissue acquisition by EUS-FNB was successful in all patients. The optimal histologic core procurement rate was 87.1 % (61/70) for the 25G needle vs. 97.1 % (68/70) for the 22G; difference -10 % (95 % confidence interval -17.35 % to -2.65 %). High quality specimens were more frequently obtained in the 22G group than in the 25G group (70.0 % [49/70] vs. 28.6 % [20 /70], respectively; P < 0.001). The overall diagnostic accuracy did not differ between the groups (97.4 % for 25G vs. 100 % for 22G). CONCLUSIONS: The 25G Franseen needle was inferior to the 22G needle in histologic core procurement. Therefore, for cases in which tissue architecture is pivotal for diagnosis, a 22G needle, which procures relatively higher quality specimens than the 25G needle, should be used.