Neuroendocrine Tumor with Metachronous Gastrointestinal Stromal Tumor in a Patient: A Case Report.

Neuroendocrine tumors (NETs) that arise from neuroendocrine cells can develop in most organs; however, it is rarely found in the duodenal papilla. Conversely, gastrointestinal stromal tumors (GISTs), which are mostly asymptomatic and detected incidentally, are usually found in the stomach and very rarely occur metachronously with NETs. A 42-year-old female with no specific underlying disease underwent gastroscopy due to epigastric pain. Biopsy of enlarged major and minor duodenal papilla confirmed the diagnosis of a NET. Endoscopic papillectomy of the major and minor papillae was performed. Multiple duodenal and jejunal submucosal nodules were seen on biliary CT performed at the 30 months follow-up. Pylorus-preserving pancreaticoduodenectomy was performed due to the suspicion of multiple recurrent NETs and muscularis propria involvement on endoscopic ultrasound. Surgical specimen biopsy confirmed the diagnosis of multiple duodenal and jejunal GIST lesions and a metastatic NET in the duodenal lymph node. We report a rare case of a GIST detected in the duodenum during follow-up after the diagnosis and papillectomy of duodenal papilla NET.

Benzyl Isothiocyanate Attenuates Inflammasome Activation in Pseudomonas aeruginosa LPS-Stimulated THP-1 Cells and Exerts Regulation through the MAPKs/NF-κB Pathway.

Inflammasomes are a group of intracellular multiprotein platforms that play important roles in immune systems. Benzyl isothiocyanate (BITC) is a constituent of cruciferous plants and has been confirmed to exhibit various biological activities. The modulatory effects of BITC on inflammasome-mediated interleukin (IL)-1ß expression and its regulatory mechanisms in Pseudomonas aeruginosa (P. aeruginosa) LPS/ATP-stimulated THP-1 cells was investigated. Monocytic THP-1 cells were treated with phorbol myristate acetate (PMA) to induce differentiation into macrophages. Enzyme-linked immunosorbent assays (ELISA) were performed to measure the levels of IL-1ß produced in P. aeruginosa LPS/ATP-exposed THP-1 cells. Western blotting was performed to examine the BITC modulatory mechanisms in inflammasome-mediated signaling pathways. BITC inhibited IL-1ß production in P. aeruginosa LPS/ATP-induced THP-1 cells. BITC also inhibited activation of leucine-rich repeat protein-3 (NLRP3) and caspase-1 in P. aeruginosa LPS/ATP-induced THP-1 cells. Furthermore, we show that mitogen-activated protein kinase (MAPK) and nuclear factor-κB (NF-κB) activation in P. aeruginosa LPS was attenuated by BITC. These BITC-mediated modulatory effects on IL-1ß production may have therapeutic potential for inflammasome-mediated disorders such as a nasal polyp.

Pancreatic Acinar Cell Cystadenoma Mimicking Pancreatic Serous Cystadenoma.

Acinar cell cystadenoma, also known as an acinar cystic transformation of the pancreas, is an exceedingly rare but benign pancreatic lesion. A 51-year-old woman was transferred to Inje University Busan Paik Hospital because of an 8 cm-sized calcified, multiseptated, and multilocular cystic mass in the pancreatic tail observed during abdominal CT performed at another hospital. The patient did not complain of abdominal pain or other symptoms, and her laboratory findings were normal. MRI showed that the cyst was not connected to the main pancreatic duct. A pancreatic serous cystadenoma was suspected, and a laparoscopic distal pancreatectomy was performed. The resected mass was composed of variable sized multilocular cysts with incomplete septa and focally lined by epithelium with acinar differentiation. The patient was diagnosed with acinar cell cystadenoma and is currently being followed up regularly. No complications or recurrences have been observed.

A comparative study of pre- or subpectoral expander position with the fenestrated Acellular dermal matrix anterior coverage, on drainage volume and Seroma Formation after Non-Nipple-Sparing Mastectomy.

BACKGROUND: It has been reported that the use of the acellular dermal matrix (ADM) in expander-based breast reconstruction is related to an increase in seroma-related complications. The aim of this study is to compare the actual drainage volume, time to drain removal, and seroma formation rate in patients with prepectoral expander placement with anterior coverage of a fenestrated ADM to those patients with partial subpectoral expander placement with inferior coverage of a fenestrated ADM. METHODS: This is a single-surgeon retrospective review of patients who underwent prepectoral expander-based breast reconstruction following non-nipple-sparing mastectomy. Patient demographics, operative data, and complications were analyzed and multivariate linear regression analyses were conducted to evaluate the significance of factors that influences total volume of fluid formation. RESULTS: A total of 89 breasts from 87 patients were included in the study. Twenty-seven breasts had prepectoral expander reconstruction and 62 breasts had partial subpectoral expander reconstruction. Mean total volumes of fluid formation (total drainage volume + additional aspirated volume) were not significantly different (p = 0.190) in the two groups. In the subpectoral group only, high body mass index (BMI) was correlated with the total volume of fluid formation among the independent factors. (p = 0.017) CONCLUSIONS: Although total drainage volume was not significantly different between prepectoral and subpectoral groups, prepectoral positioning of the expander can be a protective factor against seroma formation in high BMI patients. Further definitive studies with larger patient numbers are warranted to corroborate these data and draw definitive conclusions.

Percutaneous Trans-splenic Obliteration for Duodenal Variceal bleeding: A Case Report.

Duodenal varices are a serious complication of portal hypertension. Bleeding from duodenal varices is rare, but when bleeding does occur, it is massive and can be fatal. Unfortunately, the optimal therapeutic modality for duodenal variceal bleeding is unclear. This paper presents a patient with duodenal variceal bleeding that was managed successfully using percutaneous trans-splenic variceal obliteration (PTVO). A 56-year-old man with a history of alcoholic cirrhosis presented with a 6-day history of melena. Emergency esophagogastroduodenoscopy revealed a large, bluish mass with a nipple sign in the second portion of the duodenum. Coil embolization of the duodenal varix was performed via a trans-splenic approach (i.e., PTVO). The patient no longer complained of melena after treatment. The duodenal varix was no longer visible at the follow-up esophagogastroduodenoscopy performed three months after PTVO. The use of PTVO might be a viable option for the treatment of duodenal variceal bleeding.

Intraosseous Hemangioma of Nasal Bone: Unusual Cause of Epiphora.

Intraosseous hemangioma is very rare, accounting for <1% of bone tumors. Nasal bone origin of it is even rarer. A 63-year-old female patient visited our clinic with a complaint of epiphora. On physical examination, about 2-cm-sized nontender and fixed mass was palpated along the left nasomaxillary suture area. Preoperative magnetic resonance imaging findings were consistent with intraosseous hemangioma originating from the nasal bone. Epiphora was thought to be developed due to the mass effect and a marginal resection of the mass was performed. The defect was reconstructed with a septal cartilage and porous polyethylene implant (Synpor). Postoperatively, epiphora subsided and there has been no sign of recurrence or facial deformity during 6 months of follow-up.

Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study.

BACKGROUNDS: The placement of a self-expandable metal stent (SEMS) is widely used in patients with unresectable malignant biliary obstructions, but SEMSs are susceptible to occlusion by tumor ingrowth or overgrowth. The efficacy and safety of a novel paclitaxel-eluting biliary metal stent incorporating sodium caprate (MSCPM-III) were compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions. METHODS: Patients with unresectable distal malignant biliary obstructions (n = 106) were prospectively enrolled in this study at multiple treatment centers. Stents were placed endoscopically: MSCPM-III in 54 patients and CMS in 51 patients. The patients received systemic chemotherapy regimens according to their disease characteristics. RESULTS: The two groups did not differ significantly in basic characteristics or mean follow-up period. Stent occlusion occurred in 14 patients who received MSCPM-III and in 11 patients who received CMS. Time to recurrent biliary obstruction (RBO) and survival time did not differ significantly between the two groups (P  = 0.84 and P = 0.29, respectively). However, tumor size at 2 months after stent insertion was significantly decreased in patients in the MSCPM-III group with bile duct cancers or those who experienced stent migration compared with the CMS group. Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. CONCLUSIONS: Although compared with a CMS the MSCPM-III did not significantly influence time to RBO or survival duration in patients with malignant biliary obstructions, MSCPM-III reduced tumor volume and was used safely in humans.

Endoscopic Papillectomy for Synchronous Major and Minor Duodenal Papilla Neuroendocrine Tumors.

Neuroendocrine tumor (NET) of the major duodenal papilla is a rare occurrence. However, that of the minor duodenal papilla is even rarer. To date, only a few cases have been reported. Herein, we present a rare case of NETs detected at the major and minor duodenal papilla synchronously, which were successfully treated with endoscopic papillectomy without procedure-related complication. To the best of our knowledge, this is the first report of this kind in the world. Photomicrograph of the biopsy specimen stained immunohistochemically for synaptophysin showed a positive reaction of tumor cells. All resection margins were negative. Further experience with more cases will be needed to establish the exact indication of endoscopic papillectomy for duodenal papillary NETs.

Preprocedural prediction of non-curative endoscopic submucosal dissection for early gastric cancer.

BACKGROUND AND AIM: Endoscopic submucosal dissection (ESD) has been accepted as the treatment of choice for early gastric cancer (EGC) without lymph node metastasis. However, additional surgical gastrectomy should be considered after non-curative endoscopic resection. We aimed to evaluate the predictive factors associated with non-curative endoscopic resection. METHODS: Between November 2008 and June 2015, a retrospective study was conducted in a single, tertiary, referral hospital. A total of 596 EGC lesions resected by ESD were analyzed. Non-curative endoscopic resection was defined as the occurrence of lesions associated with piecemeal resection, positive resection margins, lymphovascular invasion, or lesions that did not meet the expanded indications for ESD. RESULTS: The rate of non-curative endoscopic resection was 16.1%. The mean follow-up period was 35.3 ± 25.0 months. Associated predictive factors for non-curative endoscopic resection were female sex (OR, 2.470; p = 0.004), lesion size ≥ 20 mm (OR 3.714; p < 0.001), longer procedure time (OR 2.449, p = 0.002), ulceration (OR 3.538, p = 0.002), nodularity (OR 2.967, p<0.001), depression (OR 1.806, p = 0.038), undifferentiated carcinoma (OR 2.825, p = 0.031) and lesion located in the mid or upper third of stomach (OR 7.135 and OR 4.155, p<0.001, respectively). As the number of risk factors increased, the risk of non-curative ESD also increased. CONCLUSIONS: Prior to selection of ESD, the risks associated with non-curative ESD should be considered so that appropriate treatment modalities may be selected.

Characteristics of overlooked synchronous gastric epithelial neoplasia after endoscopic submucosal dissection.

Since endoscopic submucosal dissection (ESD) has been accepted as the treatment of choice for early gastric cancer (EGC) without risk of lymph node metastasis, synchronous gastric epithelial neoplasia is no longer rare in the clinical practice. Knowledge about the characteristics associated with synchronous gastric epithelial neoplasia is of great importance to prevent delayed diagnosis.Between November 2008 and December 2014, a retrospective study was conducted in a single tertiary referral hospital. Consecutive patients who underwent ESD due to EGC or high-grade dysplasia were analyzed to evaluate the incidence of synchronous gastric epithelial neoplasia and the factors associated with synchronous and overlooked synchronous lesions.A total of 488 patients were analyzed in this study. Synchronous lesions were found in 59 patients (12.1%) during the mean 37.7 months of follow-up. Among 77 synchronous lesions, 25 lesions (32.4%) were overlooked at the time of initial ESD. Age of ≥ 65 years, moderate to severe endoscopic atrophic gastritis, and elevated morphology of primary lesions were associated with synchronous gastric epithelial neoplasia. An important factor associated with overlooked lesions is the non-elevated morphology of lesions.Careful endoscopic examination of the whole stomach is necessary in patients who are older and who have moderate to severe atrophic gastritis and elevated morphology of lesions to prevent delayed diagnosis of synchronous gastric epithelial neoplasia, especially non-elevated lesions.

Fucoxanthin Inhibits Myofibroblast Differentiation and Extracellular Matrix Production in Nasal Polyp-Derived Fibroblasts via Modulation of Smad-Dependent and Smad-Independent Signaling Pathways.

Nasal polyps (NPs) are a multifactorial disorder associated with a chronic inflammatory state of the nasal mucosa. Fucoxanthin (Fx) is a characteristic orange carotenoid obtained from brown algae and has diverse immunological properties. The present study investigated whether Fx inhibits fibrosis-related effects in nasal polyp-derived fibroblasts (NPDFs) and elucidated the molecular signaling pathways involved. The production of collagen type I (Col-1) was investigated in NP tissue via immunohistochemistry and western blot analysis. NPDFs were treated with transforming growth factor (TGF)-ß1 (1 ng/mL) in the presence or absence of Fx (5⁻30 µM). The levels of α-smooth muscle actin (α-SMA), Col-1, and phosphorylated (p)-Smad 2/3, signal protein-1 (SP-1), MAPKs (mitogen-activated protein kinases), and Akt were measured by western blot analysis. The expression of Col-1 was detected in NP tissues. TGF-ß1 stimulated the production of α-SMA and Col-1, and stimulated the contraction of collagen gel. However, pretreatment with Fx attenuated these effects. Furthermore, these inhibitory effects were mediated through modulation of both Smad 2/3 and Akt/SP-1 signaling pathways in TGF-ß1-induced NPDFs. The results from the present study suggest that Fx may be a novel anti-fibrotic agent for the treatment of NP formation.

Post-ERCP Bleeding in the Era of Multiple Antiplatelet Agents.

Background/Aims: This study aimed to determine the risk of post-endoscopic retrograde cholangiopancreatography (post-ERCP) bleeding among patients taking antiplatelet agents (APAs), particularly in the era of multiple APAs. Methods: The primary outcomes were the frequency, type, and severity of ERCP-related bleeding according to the use of APAs. Results: The frequencies of post-ERCP bleeding among the four different groups were 16 of 2,083 (0.8%) in the no drug group, 12 of 256 (4.7%) in the aspirin group, 3 of 48 (6.3%) in the single APA group, and 4 of 48 (8.3%) in the multiple APA group (p＜0.001). In the univariate analysis, post-ERCP bleeding was associated with age, pull-type sphincterotomy, and APA and was inversely associated with balloon dilation of the biliary orifice. In the multivariate analysis, pull-type sphincterotomy (odds ratio [OR], 7.829; 95% confidence interval [CI], 1.411 to 43.453; p=0.019) and country (Korea: OR, 0.124; 95% CI, 0.042 to 0.361; p＜0.001) were associated with post-ERCP bleeding. Conclusions: The frequency of post-ERCP bleeding was statistically higher in patients on any APA within 6 days prior to ERCP. However, in the multivariate analysis, APA use was not associated with post-ERCP bleeding. Until a large, adequately powered study to detect differences is performed, caution is recommended when considering invasive procedures during ERCP in patients on APAs.

Usefulness of Percutaneous Puncture in Insertion of Totally Implantable Venous Access Devices in Pediatric Patients.

PURPOSE: Totally implantable venous access devices (TIVADs) are commonly used in pediatrics for the administration of chemotherapy, antibiotics, or parenteral nutrition. TIVADs can be implanted using various techniques, including surgical cutdown (SC) and percutaneous puncture (PP). Recently, percutaneous TIVAD became popular in adults, but studies comparing between PP and SC group in pediatric patients are rare. MATERIALS AND METHODS: Data were collected and analyzed retrospectively from 23 patients who underwent TIVAD at a single institution between January 2013 and December 2015. We examined the clinical characteristics, insertion techniques, and clinical outcome. We divided the patients into 2 groups and compared PP with ultrasonography and SC using the insertion technique. We compared success rate, procedural time, and the patency rate between the 2 groups. RESULTS: Eleven TIVADS were inserted using PP, and 12 TIVADs were inserted using SC. No statistically significant difference in characteristics was found between the 2 groups. The procedural time in the PP group was shorter than that in the SC group, but the difference was not statistically significant (P=0.685). During follow-up, 1 patient in the SC group had an occlusion, and 1 patient in the PP group had an infection. CONCLUSION: PP of the internal jugular vein with ultrasonography appears to be the method of choice for TIVAD insertion owing to its similar success rate in terms of implantation and complication rate to that in SC, with shorter procedural times in pediatric patients.

[A Case of Biliary Obstruction Caused by Liver Cyst].

Most cystic lesions of the liver are found incidentally in imaging studies because they are not symptomatic, and generally do not require treatment. Rarely, however, symptomatic hepatic cysts may develop complications and require treatment. Here, we describe a case of a 77-year-old woman who developed biliary obstruction with abdominal pain due to compression of the bile duct by a simple hepatic cyst. We confirmed the diagnosis based on symptoms and imaging studies. The patient'ssymptoms improved after simple cyst ablation by sclerotherapy.

Diagnostic accuracy of 22/25-gauge core needle in endoscopic ultrasound-guided sampling: systematic review and meta-analysis.

BACKGROUND/AIMS: To compare the diagnostic accuracy of endoscopic ultrasound-guided core needle aspiration with that of standard fine-needle aspiration by systematic review and meta-analysis. METHODS: Studies using 22/25-gauge core needles, irrespective of comparison with standard fine needles, were comprehensively reviewed. Pooled sensitivity, specificity, diagnostic odds ratio (DOR), and summary receiver operating characteristic curves for the diagnosis of malignancy were used to estimate the overall diagnostic efficiency. RESULTS: The pooled sensitivity, specificity, and DOR of the core needle for the diagnosis of malignancy were 0.88 (95% confidence interval [CI], 0.84 to 0.90), 0.99 (95% CI, 0.96 to 1), and 167.37 (95% CI, 65.77 to 425.91), respectively. The pooled sensitivity, specificity, and DOR of the standard needle were 0.84 (95% CI, 0.79 to 0.88), 1 (95% CI, 0.97 to 1), and 130.14 (95% CI, 34.00 to 495.35), respectively. The area under the curve of core and standard needle in the diagnosis of malignancy was 0.974 and 0.955, respectively. The core and standard needle were comparable in terms of pancreatic malignancy diagnosis. There was no significant difference in procurement of optimal histologic cores between core and standard needles (risk ratio [RR], 0.545; 95% CI, 0.187 to 1.589). The number of needle passes for diagnosis was significantly lower with the core needle (standardized mean difference, -0.72; 95% CI, -1.02 to -0.41). There were no significant differences in overall complications (RR, 1.26; 95% CI, 0.34 to 4.62) and technical failure (RR, 5.07; 95% CI, 0.68 to 37.64). CONCLUSIONS: Core and standard needles were comparable in terms of diagnostic accuracy, technical performance, and safety profile.

Benzyl isothiocyanate inhibits inflammasome activation in E. coli LPS-stimulated BV2 cells.

Inflammasomes are multi-protein complexes that play a crucial role in innate immune responses. Benzyl isothiocyanate (BITC) is a naturally occurring compound found in cruciferous vegetables, and BITC exhibits potential as a chemopreventive agent. However, whether BITC exerts inflammasome-mediated regulatory effects on neuroinflammation is unknown. In this study, we examined the effects of BITC on inflammasome-mediated interleukin-1ß (IL-1ß) production in E. coli lipopolysaccharide (LPS)-stimulated BV2 microglial cells. IL-1ß production is tightly regulated at the post-translational level through the inflammasoume. We measured the levels of IL-1ß produced from the LPS-exposed BV2 microglial cells using enzyme-linked immunosorbent assays (ELISAs). The BITC regulatory mechanisms in inflammasome-mediated cellular signaling pathways were examined by RT-PCR, western blot analysis and electrophoretic mobility shift assays. BITC inhibited the secretion of IL-1ß induced by LPS in the BV2 microglial cells. BITC inhibited inflammasome activation and NLR family, pyrin domain containing 3 (NLRP3)-mediated caspase-1 activation, and decreased the levels of inflammasome activation pro-inflammatory mediators, including mitochondrial reactive oxygen species (ROS) and adenosine triphosphate (ATP) secretion in the LPS-stimulated BV2 microglial cells. Furthermore, we demonstrated that nuclear factor-κB (NF-κB) activation induced by LPS was inhibited by BITC, which may contribute to the attenuated secretion of IL-1ß. These BITC-mediated inhibitory effects on IL-1ß expression may thus regulate neuroinflammation through the inflammasome-mediated signaling pathway.

Outcomes of ERCP in Billroth II gastrectomy patients.

BACKGROUND AND AIMS: ERCP is a difficult procedure to perform in Billroth II gastrectomy patients because of altered anatomy. We investigated the outcomes and risk factors for adverse events with ERCP using a cap-fitted forward-viewing endoscope with endoscopic papillary balloon dilation (EPBD) in Billroth II gastrectomy patients. METHODS: The records for Billroth II gastrectomy patients who underwent ERCP using a cap-fitted forward-viewing endoscope with EPBD at 5 institutions between August 2008 and April 2014 were retrospectively reviewed. The outcomes and risk factors for adverse events resulting from this treatment were analyzed. RESULTS: In total, 165 patients were identified. ERCP was technically successful in 144 patients (87.3%) and clinically successful in 141 patients (85.5%). Adverse events occurred in 38 patients (23.0%): perforation in 3 cases (1.8%), pancreatitis in 13 cases (7.9%), and asymptomatic hyperamylasemia in 22 patients (13.3%). In univariate analysis, ≥2 ERCP sessions, periampullary diverticulum, and common bile duct (CBD) stone size ≥ 12 mm were found to be associated with ERCP-related adverse events. In multivariate analysis, ≥2 ERCP sessions (odds ratio [OR], 4.762; 95% confidence interval [CI], 1.472-15.402; P = .009) and a CBD stone size ≥ 12 mm (OR, 3.213; 95% CI, 1.140-9.057; P = .027) were significant. CONCLUSIONS: ERCP using a cap-fitted forward-viewing endoscope with EPBD is feasible in Billroth II gastrectomy patients. In patients with ≥2 ERCP sessions or a CBD stone size ≥ 12 mm, special attention should be paid to the possible occurrence of significant adverse events.

Endoscopic wire-guided papillectomy versus conventional papillectomy for ampullary tumors: A prospective comparative pilot study.

BACKGROUND AND AIM: A major concern about endoscopic snare papillectomy (ESP) is the risk of procedure-related pancreatitis. To maintain pancreatic duct access for stent placement after ESP, wire-guided ESP (WP) was introduced. The aim of the study was to compare post-procedure pancreatitis rates, the success rate of pancreatic stent insertion, and complete resection rates between WP and conventional ESP (CP) procedures. METHODS: This was a multi-center, prospective, randomized pilot study. Forty-five patients with ampullary tumors were randomly assigned to a WP group (n = 22) or a CP group (n = 23). In the WP group, a guidewire was placed in the pancreatic duct prior to ESP. A 5-Fr pancreatic stent was passed over the guidewire and placed across the pancreatic duct orifice. RESULTS: Complete resection was achieved in 20 patients (91%) in the WP group and 18 patients (78%) in the CP group (P = 0.414). A pancreatic stent was placed successfully in all patients in the WP group but in only 15 patients (65%) in the CP group (P = 0.004). Post-papillectomy pancreatitis occurred in four (18%) patients in the WP and three (13%) patients in the CP groups (P = 0.960). In the CP group, three of eight (37.5%) patients without stents developed pancreatitis compared with zero of 15 patients with stents (P = 0.032). CONCLUSIONS: The WP method is a useful technique used to insert a pancreatic stent after ESP, compared with CP. However, there was no significant difference in the post-procedure pancreatitis or complete resection rates between the two methods.

Oral udenafil and aceclofenac for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: a randomized multicenter study.

BACKGROUND/AIMS: Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Combination therapy w ith ora l udenafil and aceclofenac may reduce the occurrence of post-ERCP pancreatitis by targeting different pathophysiological mechanisms. We investigated whether combining udenafil and aceclofenac reduced the rates of post-ERCP pancreatitis. METHODS: A prospective, randomized, double-blind, placebo-controlled, multicenter study was conducted in four academic medical centers. Between January 2012 and June 2013, a total of 216 patients who underwent ERCP were analyzed for the occurrence of post-ERCP pancreatitis. Patients were determined to be at high risk for pancreatitis based on validated patient and procedure-related risk factors. RESULTS: Demographic features, indications for ERCP, and therapeutic procedures were similar in each group. There were no significant differences in the rate (15.8% [17/107] vs. 16.5% [18/109], p = 0.901) and severity of post-ERCP pancreatitis between the udenafil/aceclofenac and placebo groups. One patient in each group developed severe pancreatitis. Multivariate analyses indicated that suspected dysfunction of the sphincter of Oddi and endoscopic papillary balloon dilation without sphincterotomy were associated with post-ERCP pancreatitis. CONCLUSIONS: Combination therapy with udenafil and aceclofenac is not effective for the prevention of post-ERCP pancreatitis.