Endobiliary Radiofrequency Ablation Using a Short-Type Balloon Enteroscope in Patients with Surgically Altered Anatomy.

BACKGROUND: Endoscopic radiofrequency ablation (RFA) is expected to prolong stent patency for malignant biliary obstruction (MBO). However, its feasibility when used in conjunction with a balloon enteroscope (BE) in patients with surgically altered anatomy (SAA) remains unknown. AIMS: This study aimed to investigate the feasibility of RFA combined with metal stent insertion under BE guidance for MBO in patients with SAA. METHODS: Thirty-seven patients who underwent treatment between October 2016 and January 2021 and met the eligibility criteria were investigated retrospectively. Study outcomes included technical and clinical success, recurrent biliary obstruction (RBO), and other adverse events besides RBO associated with RFA with metal stent placement using BE. RESULTS: Technical and clinical success rates were 100% (37/37) each. The rates of early and late adverse events were 8.1% (3/37) and 8.1% (3/37), respectively. RBO occurred in 32.4% (12/37) of the patients, and the median time to RBO was 296 days. The cause of RBO was ingrowth in eight patients, overgrowth in three patients, and indeterminate in one patient. All reinterventions for RBO were successful using the BE approach; all ingrowths, except one, were recanalized using additional RFA without additional stent placement. The frequency of reintervention-related adverse events was 9.1% (1/11). The median time to RBO after reintervention was 166 days. CONCLUSIONS: This study demonstrated the technical safety and feasibility as well as good long-term outcomes of endobiliary RFA combined with metal stent placement under BE guidance. This approach may be a useful option for treating MBO in patients with SAA.

Safety and Efficacy of Gemcitabine Plus Nab-Paclitaxel for Metastatic Pancreatic Cancer Patients Undergoing Biliary Stent Placement.

BACKGROUND: Gemcitabine plus nab-paclitaxel (GnP) is the first-line chemotherapeutic regimen for metastatic pancreatic cancer (MPC); however, there are concerns regarding its safety in patients undergoing biliary stent placement. This study aimed to examine the tolerability and efficacy of GnP in MPC patients who underwent biliary stent placement. METHODS: A total of 105 MPC patients who had received GnP treatment between 2015 and 2020 were included and investigated. The patients were divided into two groups: those undergoing biliary stent placement for symptomatic biliary obstruction (BO) (With-BO group) and those without biliary stent placement (Without-BO group). The best tumor response, overall survival (OS), and adverse events in each group were compared. RESULTS: The partial response, stable disease, and progressive disease rates were 22%, 61%, and 14.6% in the With-BO group, and 26.6%, 46.9%, and 21.9% in the Without-BO group, respectively, with no significant differences. The median OS was 12.2 months and 14.6 months in the With-BO and Without-BO groups, respectively (P = 0.483). Grade 3 or higher biliary tract-related events were significantly more common in the With-BO group (41.5%) than in the Without-BO group (1.6%) (P < 0.001), but all events were managed successfully by urgent intervention. The rates of any treatment-related toxicities, including febrile neutropenia, were not significantly different, and there were no chemotherapy-related deaths in either group. CONCLUSIONS: GnP can be as tolerable and effective in MPC patients with biliary stents as in those without biliary stents. However, careful management and appropriate reintervention to treat biliary tract-related adverse events are required.

Safety and Efficacy of Endoscopic Retrograde Cholangiopancreatography in Patients with Performance Status 4.

BACKGROUND: The risk related to endoscopic retrograde cholangiopancreatography (ERCP) in patients with Eastern Cooperative Oncology Group performance status (PS) 4 is uncertain and remains a concern. AIMS: We aimed to examine the safety and efficacy of ERCP in patients with PS4 compared to those in patients with PS0-3. METHODS: A total of 1845 patients met the eligibility criteria for study inclusion between 2014 and 2018. The patients were divided into two groups: PS0-3 and PS4 groups. The adverse event and therapeutic success rates in each group were compared. Propensity score matching was performed to adjust for differences between the groups. RESULTS: The therapeutic success rate was 96% in both groups. The overall adverse event rate was 6% and 10% in the PS0-3 and PS4 groups, respectively, showing no significant difference (P = 0.272). Although the rates of pancreatitis, bleeding, perforation, and cholangitis were equivalent in both groups, the pulmonary adverse event rate was significantly higher in the PS4 group (5% vs. 0.4%; P = 0.006). Severe adverse events were also significantly more frequent in the PS4 group (8% vs. 2%; P = 0.012). Multivariate analyses showed that long procedure time was a significant risk factor for adverse events in patients with PS4 (odds ratio, 10.70; 95% CI 1.30-87.70; P = 0.028). CONCLUSIONS: Although ERCP can be performed effectively in patients with PS4, the risk of pulmonary and severe adverse events is high. Prolonged procedures should be avoided in patients with PS4.

Effect of Central Corticotropin-Releasing Factor on Hepatic Lipid Metabolism and Inflammation-Related Gene Expression in Rats.

Corticotropin-releasing factor (CRF) in the brain acts on physiological and pathophysiological modulation of the hepatobiliary system. Central CRF administration aggravates experimental acute liver injury by decreasing hepatic blood flow. Conversely, minimal evidence is available regarding the effect of centrally acting CRF on hepatic lipid metabolism and inflammation. We examined whether central CRF affects hepatic lipid metabolism and inflammation-related gene expression in rats. Male Long Evans rats were intracisternally injected with CRF (10 µg) or saline. Rats were sacrificed 2 h, 6 h, and 24 h after the CRF injection, the liver was isolated, and mRNA was extracted. Next, hepatic lipid metabolism and inflammation-related gene expression were examined. Hepatic SREBF1 (sterol regulatory element-binding transcription factor 1) mRNA levels were significantly increased 6 h and 24 h after intracisternal CRF administration when compared with those in the control group. Hepatic TNFα and IL1ß mRNA levels increased significantly 6 h after intracisternal CRF administration. Hepatic sympathectomy or guanethidine treatment, not hepatic branch vagotomy or atropine treatment, inhibited central CRF-induced increase in hepatic SREBF1, TNFα and IL1ß mRNA levels. These results indicated that central CRF affects hepatic de novo lipogenesis and inflammation-related gene expression through the sympathetic-noradrenergic nervous system in rats.

Endobiliary radiofrequency ablation combined with bilateral metal stent placement for malignant hilar biliary obstruction.

BACKGROUND: The effectiveness of endobiliary radiofrequency ablation (RFA) is still uncertain, especially in patients with malignant hilar biliary obstruction (MHBO). We examined the efficacy of endobiliary RFA followed by bilateral self-expandable metal stent (SEMS) placement for unresectable MHBO. METHODS: 41 patients met the eligibility criteria for study inclusion. We evaluated the technical success, functional success, and recurrent biliary obstruction (RBO) associated with RFA with bilateral SEMS placement. RESULTS: The technical and functional success rates were both 95.1 % (39/41). The RBO rate was 38.5 % (15/39), and the median time to RBO was 230 days. Stricture length was positively correlated with time to RBO in the multivariate analysis (P = 0.03). The median time to RBO was significantly longer in patients with strictures > 15 mm in length than in those with strictures ≤ 15 mm (314 vs. 156 days; P = 0.02). CONCLUSIONS: The present study showed that endobiliary RFA with bilateral SEMS placement achieved good results, but selection of patients with an appropriate stricture length may be needed to obtain a sufficient ablative effect.

Early Covered Self-Expandable Metal Stent Placement Is Effective for Massive Post-endoscopic Sphincterotomy Bleeding.

BACKGROUND: Placement of covered self-expandable metallic stent (CSEMS) for post-endoscopic sphincterotomy (ES) bleeding achieves excellent hemostasis results. Although CSEMS placement is typically performed after failure of conventional endoscopic combination therapy, its excellent outcomes may justify earlier placement. AIMS: We aimed to examine the efficacy of "early" CSEMS placement for massive post-ES bleeding. METHODS: The medical records of 2750 patients who underwent ES between 2005 and 2019 were reviewed retrospectively, and 61 patients who developed massive post-ES bleeding were enrolled. These patients were divided into those who underwent early CSEMS placement (E-CSEMS group) and those who underwent conventional endoscopic combination therapy (Conventional group). The outcomes of hemostasis procedures were compared between the groups. RESULTS: The primary success rates of endoscopic hemostasis were 100% (21/21) and 98% (39/40) in the E-CSEMS group and Conventional group, respectively, without significant differences (P = 1.000). However, in the E-CSEMS group, re-bleeding was significantly less frequent (5% vs. 31%; P = 0.023), the median hemostasis procedure time was significantly shorter (14 min vs. 26 min; P < 0.001), and transfusion after initial hemostasis treatment was less commonly required (10% vs. 38%; P = 0.034). Multivariate analyses showed that hemodialysis was associated with a significantly higher re-bleeding rate (P = 0.029), while CSEMS placement was associated with a significantly lower re-bleeding rate (P = 0.039). CONCLUSIONS: Early CSEMS placement may be effective for improving the clinical outcomes of massive post-ES bleeding by decreasing re-bleeding and the extent of bleeding.

Effect of Adrenergic Agonists on High-Fat Diet-Induced Hepatic Steatosis in Mice.

The autonomic nervous system, consisting of sympathetic and parasympathetic branches, plays an important role in regulating metabolic homeostasis. The sympathetic nervous system (SNS) regulates hepatic lipid metabolism by regulating adrenergic receptor activation, resulting in the stimulation of hepatic very-low-density lipoprotein-triglyceride (TG) production in vivo. However, only a few studies on the relationship between SNS and hepatic steatosis have been reported. Here, we investigate the effect of adrenergic receptor agonists on hepatic steatosis in mice fed a high-fat diet (HFD). The α-adrenergic receptor agonist phenylephrine (10 mg/kg/d) or the ß-adrenergic receptor agonist isoproterenol (30 mg/kg/d) was coadministered with HFD to male mice. After five weeks, hepatic steatosis, TG levels, and hepatic fat metabolism-related biomarkers were examined. HFD treatment induced hepatic steatosis, and cotreatment with phenylephrine, but not isoproterenol, attenuated this effect. Phenylephrine administration upregulated the mRNA levels of hepatic peroxisome proliferator-activated receptor alpha and its target genes (such as carnitine palmitoyltransferase 1) and increased hepatic ß-hydroxybutyrate levels. Additionally, phenylephrine treatment increased the expression of the autophagosomal marker LC3-II but decreased that of p62, which is selectively degraded during autophagy. These results indicate that phenylephrine inhibits hepatic steatosis through stimulation of ß-oxidation and autophagy in the liver.

Δ40p53α suppresses tumor cell proliferation and induces cellular senescence in hepatocellular carcinoma cells.

Splice variants of certain genes impact on genetic biodiversity in mammals. The tumor suppressor TP53 gene (encoding p53) plays an important role in the regulation of tumorigenesis in hepatocellular carcinoma (HCC). Δ40p53α is a naturally occurring p53 isoform that lacks the N-terminal transactivation domain, yet little is known about the role of Δ40p53α in the development of HCC. Here, we first report on the role of Δ40p53α in HCC cell lines. In the TP53+/Δ40 cell clones, clonogenic activity and cell survival dramatically decreased, whereas the percentage of senescence-associated ß-galactosidase (SA-ß-gal)-positive cells and p21 (also known as WAF1, CIP1 and CDKN1A) expression significantly increased. These observations were clearly attenuated in the TP53+/Δ40 cell clones after Δ40p53α knockdown. In addition, exogenous Δ40p53 expression significantly suppressed cell growth in HCC cells with wild-type TP53, and in those that were mutant or null for TP53 Notably, Δ40p53α-induced tumor suppressor activity was markedly attenuated in cells expressing the hot-spot mutant Δ40p53α-R175H, which lacks the transcription factor activity of p53. Moreover, Δ40p53α expression was associated with increased full-length p53 protein expression. These findings enhance the understanding of the molecular pathogenesis of HCC and show that Δ40p53α acts as an important tumor suppressor in HCC cells.

Balloon enteroscopy-assisted radial incision and cutting method for refractory hepaticojejunostomy anastomotic strictures.

BACKGROUND: Balloon enteroscopy-assisted balloon dilation and temporary biliary stent placement are effective for hepaticojejunostomy anastomotic strictures (HJAS), but the re-stenosis rates are relatively high. We examined the feasibility and efficacy of a novel treatment technique for refractory HJAS, called balloon enteroscopy-assisted radial incision and cutting (BE-RIC). METHODS: Between January 2016 and June 2018, 11 patients with refractory HJAS that recurred after balloon dilation and/or stent placement, underwent BE-RIC. We evaluated the technical success, clinical success, adverse events, and re-stenosis rates associated with BE-RIC. RESULTS: The technical success rate of BE-RIC was 91 % (10/11). Clinical success was achieved in all patients who underwent technically successful procedures. The procedure-related adverse event rate was 9 % (1/11). No re-stenosis was observed during the follow-up period; 9 patients were followed up for more than 6 months, and of these, 5, 4, and 2 patients were followed up for more than 12, 18, and 24 months, respectively, without re-stenosis. CONCLUSIONS: BE-RIC for refractory HJAS showed favorable results. BE-RIC might be a useful option for treating refractory HJAS.

Combined side-by-side and stent-in-stent method for triple metal stenting in patients with malignant hilar biliary obstruction.

BACKGROUND AND AIM: Endoscopic placement of three branched self-expandable metallic stents (SEMS) for high-grade malignant hilar biliary obstruction (MHBO) is technically challenging. We examined the feasibility and efficacy of a novel stenting method combining side-by-side and stent-in-stent (SBSIS) placement for MHBO. METHODS: Between January 2015 and December 2018, 27 consecutive patients with high-grade MHBO underwent SBSIS placement. We evaluated the technical success, functional success, recurrent biliary obstruction (RBO), adverse events other than RBO, and reintervention success rates associated with SBSIS placement. RESULTS: Technical success rate was 85% (23/27). Insertion of the third SEMS failed in four patients, and median diameter of the common bile duct (CBD) was significantly smaller in patients in whom technical failure occurred (5 mm vs 8 mm; P = 0.004). Functional success was achieved in all patients in whom the procedure was a technical success. Rate of adverse events other than RBO was 15% (4/27). RBO rate was 43% (10/23), and median time to RBO was 157 days. Success rate of endoscopic reintervention for RBO was 89% (8/9). CONCLUSION: SBSIS placement showed favorable results and is a promising option in patients with high-grade MHBO requiring triple metal stenting. However, it might be preferable to avoid SBSIS in patients with a narrow CBD. Clinical Trial Registry: UMIN000035721.

Assessing the diagnostic yield of controllable biopsy-forceps for biliary strictures.

OBJECTIVE: Biliary forceps biopsies are essential for differentially diagnosing biliary strictures and evaluating the preoperative superficial intraductal spread of bile duct cancers; however, these biopsies are technically demanding and time consuming. Using controllable biopsy-forceps (C-BF), which enable the tip's angle to be adjusted by up to 90°, may facilitate the procedure and improve the diagnostic yield for biliary biopsies. This study aimed to examine the efficacy of C-BF associated with the diagnosis of biliary strictures. MATERIALS AND METHOD: Between 2009 and 2015, 110 patients with biliary strictures underwent biliary biopsies using C-BF. We retrospectively evaluated the diagnostic yield of C-BF for biliary strictures and determined the success rate associated with obtaining adequate samples during mapping biopsies to evaluate the superficial intraductal tumor spread. RESULTS: The technical success rate for biliary biopsies using C-BF was 99% (109/110). The sensitivity, specificity and accuracy of the diagnoses of biliary strictures were 60% (46/77), 100% (33/33) and 72% (79/110), respectively. Regarding the mapping biopsy procedures, adequate samples were successfully obtained from 96% (22/23), 92% (11/12), 80% (12/15), 75% (9/12) and 31% (5/16) of the intrapancreatic common bile ducts, upper common bile ducts, confluences of the hepatic ducts, right intrahepatic bile ducts and left intrahepatic bile ducts, respectively. CONCLUSIONS: C-BF may facilitate biliary cannulation and mapping biopsies of the common bile duct and the right intrahepatic bile duct. However, given that the diagnostic sensitivity was 60%, further modifications are expected and necessary to maximize the utility of the controllable mechanism.

Ezetimibe for the treatment of non-alcoholic fatty liver disease: A meta-analysis.

AIM: Several studies on the efficacy of ezetimibe, a potent inhibitor of cholesterol absorption, in treating non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) have been published; however, the results are inconsistent. We undertook a meta-analysis to evaluate the efficacy of ezetimibe in treating NAFLD and NASH. METHODS: PubMed, Medline, and Cochrane Library Full Text Database were searched until June 2016. The main inclusion criteria included original studies investigating the use of ezetimibe for the treatment of NAFLD and NASH. Identification of published work and data extraction were carried out by two reviewers based on the inclusion and exclusion criteria. All analyses were carried out using Comprehensive Meta-Analysis version 3 software. RESULTS: An initial search identified 103 peer-reviewed articles and abstracts. Six studies (two randomized controlled and four single-arm trials) involving 273 participants with NAFLD and NASH were identified. Ezetimibe significantly reduced serum aspartate aminotransferase, alanine aminotransferase, and γ-glutamyl transpeptidase levels, and hepatic steatosis and hepatocyte ballooning. However, hepatic inflammation and fibrosis did not improve by ezetimibe treatment in patients with NAFLD and NASH. In randomized controlled trials, only hepatocyte ballooning improved with ezetimibe treatment. CONCLUSIONS: Although ezetimibe attenuated serum liver enzymes and hepatic steatosis and ballooning in six studies, it improved only hepatocyte ballooning in randomized controlled trials. Larger studies and more randomized placebo-controlled trials are necessary to determine the effects of ezetimibe on NAFLD and NASH.

Simultaneous Versus Sequential Side-by-Side Bilateral Metal Stent Placement for Malignant Hilar Biliary Obstructions.

BACKGROUND: Endoscopic bilateral self-expandable metallic stent (SEMS) placement for malignant hilar biliary obstructions (MHBOs) is technically demanding, and a second SEMS insertion is particularly challenging. A simultaneous side-by-side (SBS) placement technique using a thinner delivery system may mitigate these issues. AIMS: We aimed to examine the feasibility and efficacy of simultaneous SBS SEMS placement for treating MHBOs using a novel SEMS that has a 5.7-Fr ultra-thin delivery system. METHODS: Thirty-four patients with MHBOs underwent SBS SEMS placement between 2010 and 2016. We divided the patient cohort into those who underwent sequential (conventional) SBS placement between 2010 and 2014 (sequential group) and those who underwent simultaneous SBS placement between 2015 and 2016 (simultaneous group), and compared the groups with respect to the clinical outcomes. RESULTS: The technical success rates were 71% (12/17) and 100% (17/17) in the sequential and simultaneous groups, respectively, a difference that was significant (P = .045). The median procedure time was significantly shorter in the simultaneous group (22 min) than in the sequential group (52 min) (P = .017). There were no significant group differences in the time to recurrent biliary obstruction (sequential group: 113 days; simultaneous group: 140 days) or other adverse event rates (sequential group: 12%; simultaneous group: 12%). CONCLUSIONS: Simultaneous SBS placement using the novel 5.7-Fr SEMS delivery system may be more straightforward and have a higher success rate compared to that with sequential SBS placement. This new method may be useful for bilateral stenting to treat MHBOs.

Diagnostic accuracy of real-time tissue elastography for the staging of liver fibrosis: a meta-analysis.

OBJECTIVE: To evaluate the overall accuracy of real-time tissue elastography (RTE) for the staging of liver fibrosis. METHODS: We systematically reviewed 15 studies (1,626 subjects) in which sensitivity and specificity of RTE for liver fibrosis are available. For each cut-off stage of fibrosis, i.e., F ≥ 1, F ≥ 2, F ≥ 3, and F ≥ 4, summary sensitivity and specificity were estimated using a bivariate random-effects model. Publication bias was assessed using funnel plots and Egger's test. RESULTS: Summary sensitivity and specificity were 0.79 and 0.76 for F ≥ 2, 0.82 and 0.81 for F ≥ 3, and 0.74 and 0.84 for F ≥ 4, respectively. Meta-regressions revealed scoring methods of RTE and liver diseases in the samples might not influence sensitivity and specificity of RTE. However, the estimated accuracy of RTE might be overestimated due to publication bias (p = 0.004 for F ≥ 2, p < 0.001 for F ≥ 3, and p = 0.002 for F ≥ 4). CONCLUSIONS: RTE is not highly accurate for any cut-off stage of fibrosis. Compared with findings of meta-analyses on Transient Elastography and Acoustic Radiation Force Impulse imaging, the overall accuracy of RTE seems to be nearly identical for the evaluation of significant liver fibrosis, but less accurate for the evaluation of cirrhosis. KEY POINTS: • Non-invasive methods for evaluating liver fibrosis are necessary to replace liver biopsy. • ARFI is as accurate as TE for evaluating liver fibrosis. • RTE may be as accurate as TE and ARFI for fibrosis. • RTE may be less accurate than TE and ARFI for cirrhosis. • The estimated accuracy of RTE may be overestimated by publication bias.

Case of cholangiocellular carcinoma in a patient with glycogen storage disease type Ia.

Glycogen storage disease (GSD) type Ia is caused by a deficiency in glucose-6-phosphatase. Long-term complications, including renal disease, gout, osteoporosis and pulmonary hypertension, develop in patients with GSD type Ia. In the second or third decade, 22-75% of GSD type Ia patients develop hepatocellular adenoma (HCA). In some of these patients, the HCA evolves into hepatocellular carcinoma. However, little is known about GSD type Ia patients with HCA who develop cholangiocellular carcinoma (CCC). Here, we report for the first time, a patient with GSD type Ia with HCA, in whom intrahepatic CCC was developed.

Characteristics of bile acid composition in high fat diet-induced nonalcoholic fatty liver disease in obese diabetic rats.

Bile acid has attracted attention as a signal transmission molecule in energy metabolism. Although a high-fat diet (HFD) or obesity is known to increase hepatic fat content and alter bile acid composition, the changes in bile acid composition due to HFD or obesity remain to be elucidated. We sought to examine the bile acid composition in high fat diet-induced non-alcoholic fatty liver disease (NAFLD) in obese diabetic rats. Eight-week-old male spontaneously diabetic Torii fatty (SDTF) rats or control rats were fed an HFD. Twelve weeks post the commencement of HFD, serum and hepatic bile acid compositions and serum GLP-1 levels, which is stimulated by the secondary bile acid deoxycholic acid (DCA), were measured. The correlation between the bile acid composition and serum GLP-1 levels was also examined. While serum and hepatic levels of cholic acid (CA), a primary bile acid, tended to decrease in HFD-fed control rats, they were significantly decreased in HFD-fed SDTF rats. Hepatic CYP8B1, which plays a role in CA synthesis, the mRNA levels were significantly decreased in HFD-fed control and SDTF rats. In contrast, while serum and hepatic DCA levels were not changed in HFD-fed control rats, they were decreased in HFD-fed SDTF rats. Hepatic DCA/CA did not change in HFD-fed SDTF rats, but significantly increased in HFD-fed control rats. While serum GLP-1 levels were not changed in SDTF rats, they were significantly increased in HFD-fed control rats. Hepatic DCA/CA tended to correlate with serum GLP-1 levels, which tended to negatively correlate with the hepatic triglyceride content in SDTF rats. These results indicate that relatively increased DCA might contribute to an increase in serum GLP-1 levels, which inhibits hepatic steatosis in NAFLD.

Gemcitabine plus nab-paclitaxel with initial dose reduction for older patients with advanced pancreatic cancer.

OBJECTIVES: For older patients with pancreatic cancer (PC), the benefits of gemcitabine plus nab-paclitaxel (GnP) are still uncertain, and the toxicity may be excessive. We aimed to examine the efficacy and safety of modified GnP (m-GnP), which is a nab-paclitaxel reduced regimen, for older patients (≥75 years) with advanced PC. MATERIALS AND METHODS: In total, 34 patients met the eligibility criteria for study inclusion between 2015 and 2020. We evaluated the overall survival (OS), progression-free survival (PFS), best response, and adverse events associated with m-GnP treatment. RESULTS: The median OS and PFS were 15.4 months and 5.9 months, respectively. The best response was partial response in 29% (10/34), stable disease in 53% (18/34), and progressive disease in 15% of patients (5/34); one patient was not evaluated. Among the grade 3 or higher hematological adverse events, neutropenia was the most frequent, occurring in 38% of patients (13/34), whereas febrile neutropenia occurred in 3% (1/34). Grade 3 or higher non-hematological adverse events occurred in 12% of patients (4/34). Early discontinuation owing to intolerable adverse events occurred in one patient, and there were no chemotherapy-related deaths. CONCLUSIONS: The present study demonstrated that m-GnP exhibited good efficacy with acceptable toxicity. To avoid early discontinuation and maintain dose intensities, initial dose reduction may be a good option for older patients with PC when receiving GnP.

Endoscopic Ultrasound-Guided Antegrade Radiofrequency Ablation and Metal Stenting With Hepaticoenterostomy for Malignant Biliary Obstruction: A Prospective Preliminary Study.

OBJECTIVES: Endobiliary radiofrequency ablation (RFA) for malignant biliary obstruction is a promising option for improving biliary stent patency, but its efficacy and safety with endoscopic ultrasound (EUS)-guided biliary drainage are uncertain. We examined the feasibility of EUS-guided hepaticoenterostomy with antegrade stenting (EUS-HEAS) and RFA in patients with unresectable malignant biliary obstruction. METHODS: This was a prospective, single-center, single-arm, preliminary study. Twenty patients who met the eligibility criteria for inclusion between August 2018 and January 2020 were enrolled. We evaluated the technical success, functional success, recurrent biliary obstruction (RBO), and adverse events other than RBO associated with EUS-HEAS with RFA. RESULTS: The technical and functional success rates were both 80% (16/20). The procedure was unsuccessful in a total of 4 patients due to failure to insert the RFA catheter through the fistula (2 patients) or failure to pass the RFA catheter through the stricture (2 patients). Early and late adverse events other than RBO occurred in 10% (2/20) and 13% (2/16) of subjects, respectively. The RBO rate was 25% (4/16), and the median time to RBO was 276 days. The success rate of endoscopic reintervention using hepaticoenterostomy was 100% (4/4). DISCUSSION: This preliminary study showed that EUS-HEAS with RFA achieves good results but RFA catheter insertion can be difficult. Further evaluation and device improvements are warranted.