Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomised, Phase 3 trial.

BACKGROUND: The TeloVac study indicated GV1001 did not improve the survival of advanced pancreatic ductal adenocarcinoma (PDAC). However, the cytokine examinations suggested that high serum eotaxin levels may predict responses to GV1001. This Phase III trial assessed the efficacy of GV1001 with gemcitabine/capecitabine for eotaxin-high patients with untreated advanced PDAC. METHODS: Patients recruited from 16 hospitals received gemcitabine (1000 mg/m2, D 1, 8, and 15)/capecitabine (830 mg/m2 BID for 21 days) per month either with (GV1001 group) or without (control group) GV1001 (0.56 mg; D 1, 3, and 5, once on week 2-4, 6, then monthly thereafter) at random in a 1:1 ratio. The primary endpoint was overall survival (OS) and secondary end points included time to progression (TTP), objective response rate, and safety. RESULTS: Total 148 patients were randomly assigned to the GV1001 (n = 75) and control groups (n = 73). The GV1001 group showed improved median OS (11.3 vs. 7.5 months, P = 0.021) and TTP (7.3 vs. 4.5 months, P = 0.021) compared to the control group. Grade >3 adverse events were reported in 77.3% and 73.1% in the GV1001 and control groups (P = 0.562), respectively. CONCLUSIONS: GV1001 plus gemcitabine/capecitabine improved OS and TTP compared to gemcitabine/capecitabine alone in eotaxin-high patients with advanced PDAC. CLINICAL TRIAL REGISTRATION: NCT02854072.

Natural Course of Early Detected Acute Peripancreatic Fluid Collection in Moderately Severe or Severe Acute Pancreatitis.

Background and Objectives: Acute peripancreatic fluid collection (APFC) is an acute local complication of acute pancreatitis (AP) according to the revised Atlanta classification. Sometimes APFC resolves completely, sometimes it changes into a pseudocyst or walled-off necrosis (WON), so called late complications. The aim of this study is to investigate the natural course of APFC detected on early computed tomography (CT) in moderately severe (MSAP) or severe AP (SAP). Materials and Methods: From October 2014 to September 2015, patients with MSAP or SAP were enrolled if there was APFC within 48 h of onset on imaging studies at six medical centers. The status of fluid collection was followed 4-8 weeks after onset. Initial laboratory findings, CT findings and clinical scoring systems were analyzed. Results: A total of 68 patients were enrolled and APFC was completely resolved in 32 (66.7%) patients in the MSAP group and 9 (34.6%) in the SAP group. Patients with a high bedside index for severity in acute pancreatitis (BISAP) score (≥3 points) were common in the SAP group. C-reactive protein (CRP) after 48 h from admission and BUN level were also high in the SAP group. In multivariate analysis, BISAP score (≥3 points), elevation of CRP after 48 h (≥150 mg/L) and nasojejunal feeding after 48 h were risk factors for the development of late complications. Conclusions: Spontaneous resolution of APFC was more common in MSAP group and APFC can be changed to pseudocyst or WON in patients with elevated BISAP score, CRP level after 48 h, and non-improved abdominal pain.

Comparison of different types of covered self-expandable metal stents for malignant colorectal obstruction.

BACKGROUND: Stent migration is one of the main drawbacks of covered self-expandable metal stent (SEMSs), occurring in up to 40% of malignant colorectal obstruction management cases. Various types of covered SEMSs have been developed to reduce this risk. We aimed to compare the effectiveness and complication rates of the flare-type covered SEMS (Flare) with those of the double-layered covered SEMS (ComVi). METHODS: We performed a prospective, randomized study in four tertiary referral centers between July 2016 and April 2018. Patients with malignant colorectal obstruction were eligible for the study. The primary outcome was migration rate as observed within the first month. Rates of technical success, clinical success, and complications within the first month were also assessed. RESULTS: A total of 60 patients were included (mean age, 70.5 ± 12.5 years; male, 31 [51.7%]). Flare and ComVi stents were applied in 30 patients each. The Flare and ComVi groups showed comparable technical success rates (90% [27/30] vs. 96.7% [29/30], p = 0.605) and clinical success rates (85.2% [23/27] vs. 75.9% [22/29], p = 0.589). Migration occurred in three (11.1%) and four (13.8%) cases in the Flare and ComVi groups, respectively, without significant difference (p = 0.99), and the risk of other complications, including perforation and re-obstruction, did not differ between the two groups. CONCLUSIONS: Our study indicates that both flare-shape and double-layered covered SEMSs are equally effective options for the management of malignant colorectal obstruction with low migration rates when compared with previously reported migration risk of covered SEMS.

Child-Pugh, MELD, MELD-Na, and ALBI scores: which liver function models best predicts prognosis for HCC patient with ascites?

OBJECTIVE: It remains controversial whether certain treatments should apply to HCC patients with ascites due to concerns about worsening liver function. The objective of the present study is to compare the prognostic performance of 4 liver function models currently in use for HCC patients with ascites. METHODS: A total of 437 treatment-naïve, newly diagnosed HCC patients were analyzed. The predictive performance of Child-Pugh, MELD, MELD-Na, and ALBI scores were examined using ROC curve analysis. RESULTS: MELD-Na score showed good performance in predicting 1-, 2-, and 3-year mortality, particularly 1-year mortality. MELD-Na score significantly increased at 30 days after treatment in cases initially receiving best supportive care (14-17, p < .001), TACE (9-11, p < .001), and other treatment (radiotherapy, sorafenib, or systemic chemotherapy) (9-11, p = .021). For patients with advanced tumor stage and MELD-Na score ≥12, HCC-specific treatment did not offer significantly better prognosis compared with only the best supportive care (median survival: 2.2 vs. 1.8 months for HCC-specific treatment vs. best supportive care, p = .15). CONCLUSION: MELD-Na can effectively identify liver functional reserve and prognosis in HCC patients with ascites. MELD-Na, together with the tumor stage, may help establish a therapeutic strategy for them.

Clinicopathologic analysis of intraductal papillary neoplasm of bile duct: Korean multicenter cohort study.

BACKGROUND: IPNB is very rare disease and most previous studies on IPNB were case series with a small number due to low incidence. The aim of this study is to validate previously known clinicopathologic features of intraductal papillary neoplasm of bile duct (IPNB) based on the first largest multicenter cohort. METHODS: Among 587 patients previously diagnosed with IPNB and similar diseases from each center in Korea, 387 were included in this study after central pathologic review. We also reviewed all preoperative image data. RESULTS: Of 387 patients, 176 (45.5%) had invasive carcinoma and 21 (6.0%) lymph node metastasis. The 5-year overall survival was 80.9% for all patients, 88.8% for IPNB with mucosal dysplasia, and 70.5% for IPNB with invasive carcinoma. According to the "Jang & Kim's modified anatomical classification," 265 (68.5%) were intrahepatic, 103 (26.6%) extrahepatic, and 16 (4.1%) diffuse type. Multivariate analysis revealed that tumor invasiveness was a unique predictor for survival analysis. (p = 0.047 [hazard ratio = 2.116, 95% confidence interval 1.010-4.433]). CONCLUSIONS: This is the first Korean multicenter study on IPNB through central pathologic and radiologic review process. Although IPNB showed good long-term prognosis, relatively aggressive features were also found in invasive carcinoma and extrahepatic/diffuse type.

Risk factor of bleeding after endoscopic sphincterotomy in average risk patients.

BACKGROUND: For therapeutic endoscopic retrograde cholangiopancreatography (ERCP), endoscopic sphincterotomy (ES) is necessary but it can lead to complications such as bleeding. Thus, we investigated the risk factors of post-ES bleeding in average risk patients. METHODS: We retrospectively reviewed the medical records of patients who had been treated for ERCP between April 2006 and March 2013. The length of the ES incision was defined as minimal (up to proximal hooding fold), medium (between minimal and full length), and full (up to superior margin of sphincter opening). Exclusion criteria were as follows: if performed precut sphincterotomy or balloon dilatation, patients having altered anatomy or anticoagulant medications. RESULTS: A total of 3620 patients underwent ERCP and 1121 patients who underwent biliary ES were enrolled. Post-ES bleeding occurred in 108 of 1121 patients (9.6%) and mostly minor bleeding (94 patients, 87%). Length of ES was the only risk factor for post-ES bleeding in multivariate analysis. Complete hemostasis was achieved by endoscopic modalities and no serious complication developed after hemostasis. CONCLUSIONS: In average risk patients, length of ES was independent risk factor for post-ES bleeding and endoscopic hemostasis was safe and effective.

Therapeutic outcomes of endoscopic papillectomy for ampullary neoplasms: retrospective analysis of a multicenter study.

BACKGROUND: Endoscopic papillectomy (EP) is reported to be a relatively safe and reliable procedure for complete resection of ampullary neoplasms. The aim of this study was to evaluate the therapeutic outcomes and complications of EP for ampullary neoplasms. METHODS: A retrospective multicenter study was conducted with 5 participating centers from January 2007 to July 2014. A total of 104 patients who underwent EP for ampullary neoplasms were reviewed retrospectively. EP was performed by snare resection with or without submucosal lifting of the lesion. RESULTS: The mean age of patients was 60.5 ± 12.1 years, and the male-to-female ratio was 2.0:1. En bloc resection was possible in 94 patients (90.3%). A biliary and a pancreatic stent were placed after EP in 42 patients and in 60 patients, respectively. A pathologically incomplete resection was noted in 11 cases (10.6%), and 5 of these patients were treated with additional endoscopic procedure. Histology of resected specimens was as follows: low grade adenoma (43.2%), high grade adenoma (14.4%), adenocarcinoma (16.3%), hyperplastic polyp (7.7%), and others (18.4%). Of the 75 cases with low grade adenoma on biopsy specimen, 21.3% turned out to have high grade adenoma (12%) or adenocarcinoma (9.3%). Procedure-related complications occurred in 33 patients (31.7%); bleeding (18 cases, 17.3%), pancreatitis (16 cases, 15.4%), and perforation (8 cases, 7.7%). Pre-EP ERCP, saline lifting, sphincterotomy, biliary stenting, pancreatic stenting, specimen size, and cauterization were not related to post EP complications. Surgery was performed in 6 cases with pathological incomplete resection and 2 cases with complications after EP, and there were 2 cases of mortality due to complications. During follow-up endoscopy after initial success of EP, remnant tumors were found in 7 patients, one of whom underwent surgery and the others were treated endoscopically. Consequently, the overall endoscopic success rate of EP was 89.4%. CONCLUSIONS: Endoscopic papillectomy appears to be an effective treatment for ampullary neoplasms, and can be considered as an alternative to surgery. However, relatively high risk of procedure related complications is a problem that must be considered.

Type 1 autoimmune pancreatitis with histologically proven granulocytic epithelial lesions.

There are two distinct subtypes of autoimmune pancreatitis (AIP): type 1 and type 2. Type 1 AIP is the pancreatic manifestation of systemic fibroinflammatory disease, which is named as IgG4-related disease. On the other hand, type 2 AIP is a pancreatic disorder that is not associated with IgG4. Type 1 and type 2 AIP have different clinical profiles and histologic findings. We present a 22-year-old man who has been diagnosed as type 1 AIP with histologically proven granulocytic epithelial lesion after surgical resection for pancreatic head mass. Since the patient had no pancreatic duct narrowing, elevation of serum IgG4, and other organ involvement, it was very difficult to diagnose preoperatively. This is a rare and interesting case in which histologic features of type 1 and type 2 AIP coexist.

Predictors of malignancy in pure branch duct type intraductal papillary mucinous neoplasm of the pancreas: A nationwide multicenter study.

BACKGROUND/OBJECTIVES: Prediction of malignancy in patients with BD-IPMNs is critical for the management. The aim of this study was to elucidate predictors of malignancy in patients with 'pure' BD-IPMNs who had a main pancreatic duct (MPD) diameter of ≤5 mm according to the most recent international consensus criteria and in whom MPD involvement was excluded on postoperative histology. METHODS: We identified 177 patients with 'pure' BD-IPMNs based on preoperative imaging and postoperative histology from 15 tertiary referral centers in Korea. BD-IPMNs with low-grade (n = 72) and moderate-grade (n = 66) dysplasia were grouped as benign and BD-IPMNs with high-grade dysplasia (n = 10) and invasive carcinoma (n = 29) were grouped as malignancy. RESULTS: On univariate analysis, particular symptoms (jaundice and clinical pancreatitis), CT findings (cyst size > 3 cm, the presence of enhancing mural nodules) and EUS features (the presence of mural nodules, the mural nodule size > 5 mm) were significant risk factors predicting malignant BD-IPMNs. Multivariate analysis revealed that the cyst size > 3 cm (odds ratio = 9.9), the presence of enhancing mural nodules on CT (odds ratio = 19.3) and the mural nodule size > 5 mm on EUS (odds ratio = 14.9) were the independent risk factors for the presence of malignancy in BD-IPMNs (p < 0.001). CONCLUSIONS: The cyst size > 3 cm, the presence of enhancing mural nodules on CT, the mural nodule size > 5 mm on EUS are three independent predictors of malignancy in patients with 'pure' BD-IPMNs.

Incidence, risk factors and clinical course of pancreatic fluid collections in acute pancreatitis.

BACKGROUND: Acute pancreatitis is an acute inflammatory process of the pancreas with variable involvement of other regional tissues or remote organ systems. Acute fluid collections and pseudocyst formation are the most frequent complications of acute pancreatitis. AIMS: The aims of this study were to evaluate the incidence, risk factors, and clinical course of pancreatic fluid collections and pseudocyst formation following acute pancreatitis. METHODS: A prospective multicenter study was conducted in five participating centers with 302 patients diagnosed with acute pancreatitis from January 2011 to July 2012. RESULTS: The incidence of pancreatic fluid collections and pseudocyst was 42.7 and 6.3 %, respectively. Patients with fluid collections were significantly younger, compared to those without fluid collections (51.5 ± 15.9 vs. 60.4 ± 16.5 years, P = 0.000). The proportion of alcoholic etiology (54.3 %) in patients with fluid collections was significantly higher compared to other etiologies (P = 0.000). C-reactive protein (CRP) (48 h) was significantly higher in patients with fluid collections, compared to patients without fluid collections (39.2 ± 77.4 vs. 15.1 ± 36.2 mg/dL, P = 0.016). LDH (48 h) was significantly higher in patients with pseudocyst formation, compared to patients with complete resolution (1,317.6 ± 706.4 vs. 478.7 ± 190.5 IU/L, P = 0.000). Pancreatic fluid collections showed spontaneous resolution in 69.8 % (90/129) and 84.2 % of the pseudocysts disappeared or decreased in size during follow up. CONCLUSIONS: Age, CRP (48 h), and alcohol etiology are risk factors for pancreatic fluid collections. LDH (48 h) appears to be a risk factor for pseudocyst formation. Most pseudocysts showed a decrease in size or spontaneous resolution with conservative management.

Efficacy and Toxicity of Palliative Chemotherapy in Elderly Patients With Advanced Pancreatic Cancer.

OBJECTIVES: We aimed to compare the efficacy and toxicity of palliative chemotherapy in elderly patients with pancreatic ductal adenocarcinoma (PDAC) with those in younger patients. METHODS: A total of 60 patients with locally advanced or metastatic PDAC who received FOLFIRINOX or nab-paclitaxel plus gemcitabine at our institution from January 2014 to December 2021 were analyzed. Patients 70 years or older were classified into an elderly group. RESULTS: The elderly group included 16 patients (26.7%). In the elderly group, nab-paclitaxel plus gemcitabine was used more than FOLFIRINOX compared with the young group (75.0% and 25.0% vs 34.1% and 64.9%, respectively; P = 0.008). The overall survival was not significantly different between the 2 groups (15.6 vs 13.4 months, P = 0.259). However, the elderly group showed better progression-free survival (11.4 vs 7.4 months, P = 0.034). The incidence of adverse events including neutropenia (75.0% vs 81.8%, P = 0.716), thrombocytopenia (25.0% vs 31.3%, P = 0.743), and anemia (50.0% vs 43.2%, P = 0.771) was not different between the 2 groups. Peripheral neuropathy was more common in the elderly group (18.3% vs 2.3%, P = 0.054), though not statistically significant. CONCLUSION: The efficacy and toxicity of chemotherapy in elderly patients with advanced PDAC were comparable with those in younger patients.

Double-guidewire technique for selective biliary cannulation does not increase the rate of post-endoscopic retrograde cholangiopancreatography pancreatitis in patients with naïve papilla.

BACKGROUND/AIMS: This study aimed to compare the safety of the double-guidewire technique (DGT) with that of the conventional single-guidewire technique (SGT) in real-world situations. METHODS: A total of 240 patients with naïve papilla who underwent endoscopic retrograde cholangiopancreatography (ERCP) at Daegu Catholic University Medical Center between January 2021 and December 2021 were included. The primary outcome was the rate of post-ERCP pancreatitis (PEP) in the SGT and DGT groups. RESULTS: A total of 163 patients (67.9%) belonged to the SGT group, and 77 (32.1%) belonged to the DGT group. The rates of successful biliary cannulation were 95.7% and 83.1% in the SGT and DGT groups, respectively (p=0.002). In the study group, PEP occurred in 14 patients (5.8%). The PEP rates were not significantly different between the SGT and DGT groups (4.3% vs. 9.1%, p=0.150). In the multivariate analysis, the age of <50 years (odds ratio [OR], 9.305; 95% confidence interval [CI], 1.367-63.358; p=0.023) and hyperlipidemia (OR, 7.384; 95% CI, 1.103-49.424; p=0.039) were significant risk factors for PEP in the DGT group. CONCLUSION: DGT did not increase the PEP rate in patients with naïve papilla. In addition, the age of <50 years and hyperlipidemia were significant risk factors for PEP in the DGT group.

Clinical course and proposed treatment strategy for ERCP-related duodenal perforation: a multicenter analysis.

BACKGROUND AND STUDY AIMS: Endoscopic retrograde cholangiopancreatography (ERCP)-related duodenal perforation is rare but can cause high mortality. Our aim was to assess the clinical outcomes of these events. METHOD: A total of 59 patients who were diagnosed as having ERCP-related duodenal perforation at six institutions between 2000 and 2007 were enrolled in this multicenter retrospective study. We evaluated complications and mortality associated with ERCP-related duodenal perforation according to injury detection time (IDT), peritoneal irritation signs (PIS), systemic inflammation signs (SIS), and treatment modality in these patients. RESULTS: Of the 59 patients, 41 (69.5 %) and 18 (30.5 %) underwent medical and surgical treatment, respectively. Duodenal perforation-related death was observed in five patients, who had received medical therapy (n = 2) and surgical therapy (n = 3). Among medically treated patients, seven patients (17.1 %) underwent endoscopic clipping immediately after the injury; surgery was not required as a salvage therapy and there were no complications or deaths among these patients. The remaining 34 patients received antibiotics combined with therapeutic fasting and intravenous hydration. Duodenal perforation-related complications depended significantly on IDT (P = 0.0001), treatment modality (P = 0.008), PIS (P = 0.003), and SIS (P = 0.010). The duodenal perforation-related mortality was significantly related to IDT (P = 0.008) and PIS (P = 0.001). CONCLUSIONS: IDT, PIS, and SIS appear to be important prognostic factors following ERCP-related duodenal perforation. Medical therapy can be suggested as an initial treatment strategy for ERCP-related duodenal perforation, and if possible, endoscopic clipping is strongly recommended. However, surgical treatment should be considered if the perforation is not expected to seal spontaneously, or if the continuing leakage causes PIS or SIS.

Efficacy of a metallic stent covered with a paclitaxel-incorporated membrane versus a covered metal stent for malignant biliary obstruction: a prospective comparative study.

BACKGROUND: The placement of a self-expandable metallic stent (SEMS) is a widely used nonsurgical treatment method in patients with unresectable malignant biliary obstructions but SEMS is susceptible to occlusion by tumor ingrowth or overgrowth. AIM: The efficacy and safety of a metallic stent covered with a paclitaxel-incorporated membrane (MSCPM) in which paclitaxel provided an antitumoral effect was 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. A MSCPM was inserted endoscopically in 60 patients, and a CMS was inserted in 46 patients. Patients underwent systemic chemotherapy regimens alternatively according to disease characteristics. RESULTS: The two groups did not differ significantly in mean age, male to female ratio, or mean follow-up period. Stent occlusion due to tumor ingrowth occurred in 12 patients who received MSCPMs and in eight patients who received CMSs. Stent patency and survival time did not differ significantly between the two groups (p = 0.116, 0.981). Chemotherapy had no influence on stent patency, but gemcitabine-based chemotherapy was a significant prognostic factor for survival time (p = 0.012). Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. CONCLUSIONS: Although the use of a MSCPM produced no significant differences in stent patency or patient survival in patients with malignant biliary obstructions compared with the use of a CMS, this study demonstrated that MSCPM can be used safely in humans.

Factors predictive of adverse events following endoscopic papillary large balloon dilation: results from a multicenter series.

BACKGROUND: Lack of established guidelines for endoscopic papillary large balloon dilation (EPLBD) may be a reason for aversion of its use in removal of large common bile duct (CBD) stones. AIMS: We sought to identify factors predictive of adverse events (AEs) following EPLBD. METHODS: This multicenter retrospective study investigated 946 consecutive patients who underwent attempted removal of CBD stones ≥10 mm in size using EPLBD (balloon size 12-20 mm) with or without endoscopic sphincterotomy (EST) at 12 academic medical centers in Korea and Japan. RESULTS: Ninety-five (10.0 %) patients exhibited AEs including bleeding in 56, pancreatitis in 24, perforation in nine, and cholangitis in six; 90 (94.7 %) of these were classified as mild or moderate in severity. There were four deaths, three as a result of perforation and one due to delayed massive bleeding. Causative factors identified in fatal cases were full-EST and continued balloon inflation despite a persistent waist seen fluoroscopically. Multivariate analyses showed that cirrhosis (OR 8.03, p = 0.003), length of EST (full-EST: OR 6.22, p < 0.001) and stone size (≥16 mm: OR 4.00, p < 0.001) were associated with increased bleeding, and distal CBD stricture (OR 17.08, p < 0.001) was an independent predictor for perforation. On the other hand, balloon size was associated with deceased pancreatitis (≥14 mm: OR 0.27, p = 0.015). CONCLUSIONS: EPLBD appears to be a safe and effective therapeutic approach for retrieval of large stones in patients without distal CBD strictures and when performed without full-EST.

Management after endoscopic snare papillectomy for ampullary adenomas.

BACKGROUND/AIMS: This study was designed to investigate clinicopathological features of patients who underwent endoscopic snare papillectomy (ESP) and to suggest how to manage patients after the procedure according to the pathological findings. METHODOLOGY: Seventy-nine patients underwent ESP for ampullary tumors in 7 tertiary medical centers in Korea. We retrospectively reviewed the medical records of each patient and analyzed the data. RESULTS: Complete resection and complication rates of ESP were 76% and 21.7%, respectively; and pancreatitis rate was 11.5%. ESP-related mortality rate was 2.5% (n=2; 1 perforation and 1 pancreatitis). According to the pathological findings, endoscopic management was performed in 62/65 (95.4%) of low grade dysplasia (LGD) and 9/14 (64.3%) of high grade dysplasia (HGD)/cancer on pre-ESP; in 57/62 (92.0%) of LGD and 13/16 (81.3%) of HGD/cancer on ESP; and in 11/13(84.7%) of LGD and 0/6(0%) of HGD/cancer on follow-up biopsy. The rates of incomplete resection according to the pre-ESP pathological findings were 18.4% (12/65) in the LGD group and 50% (7/14) in the HGD/cancer group (p=0.033). CONCLUSIONS: HGD or cancer required surgical management. Moreover, pre-procedural HGD/cancer was associated with a high rate of incomplete resection after ESP. Therefore, if the pre-ESP pathological results revealed HGD/cancer, a careful endoscopic follow-up with imaging study or an early surgical intervention should be considered.

Venous Thromboembolism in Patients with Advanced Pancreatic Cancer Receiving Palliative Chemotherapy: Incidence and Effect on Prognosis.

Background/Aims: This study evaluated the incidence of venous thromboembolism (VTE) in patients with advanced pancreatic ductal adenocarcinoma (PDAC) at the authors' institution and analyzed the risk factors associated with VTE and the overall survival (OS). Methods: One hundred and seventy patients with locally advanced or metastatic PDAC who received palliative chemotherapy at Daegu Catholic University Medical Center from January 2011 to December 2020 were included. Results: During a median follow-up period of 341 days, 24 patients (14.1%) developed VTE. Cumulative incidence values of VTE were 4.7% (95% confidence interval [CI], 2.39-9.22) at 90 days, 9.9% (95% CI, 6.14-15.59) at 180 days, and 16.9% (95% CI, 11.50-24.36) at 360 days. Multivariate analysis showed that a carbohydrate antigen 19-9 (CA 19-9) level over 1,000 U/mL (hazard ratio [HR], 2.666; 95% CI, 1.112-6.389; p=0.028) and a history of alcohol consumption (HR, 0.327; 95% CI, 0.109-0.981; p=0.046) were significant factors associated with VTE. Patients with VTE showed a shorter median survival (347 days vs. 556 days; p=0.041) than those without VTE. Multivariate analysis revealed VTE (HR, 1.850; 95% CI, 1.049-3.263; p=0.033) and CA 19-9 level over 1,000 U/mL (HR, 1.843; 95% CI, 1.113-3.052; p=0.017) to be significant risk factors associated with OS. Conclusions: The cumulative incidence of VTE in patients with advanced PDAC was 16.9% at 360 days. While a history of alcohol consumption was a protective factor, a high CA19-9 level was a risk factor for VTE. In addition, the occurrence of VTE was associated with poor prognosis.

The effect and therapeutic compliance of adjuvant therapy in patients with cholangiocarcinoma after R0 resection: a retrospective study.

BACKGRUOUND: This study aimed to compare clinical outcomes between surveillance and adjuvant therapy (AT) groups after R0 resection for cholangiocarcinoma (CCA). METHODS: A total of 154 patients who underwent R0 resection for CCA at the Daegu Catholic University Medical Center between January 2010 and December 2019 were included. Overall survival (OS) and progression-free survival (PFS) were analyzed. RESULTS: The median follow-up duration was 899 days. There were 109 patients in the AT group and 45 patients in the surveillance group. The patients in the AT group were younger (67 years vs. 74 years, p<0.001) and included more males (64.2% vs. 46.7%, p=0.044). The proportion of patients with stage III CCA was larger in the AT group than in the surveillance group (13.8% vs. 2.2%, p=0.005). In addition, AT did not improve OS (5-year OS rate, 69.3% in the AT group vs. 64.2% in the surveillance group, p=0.806) or PFS (5-year PFS rate, 42.6% in the AT group vs. 48.9% in the surveillance group, p=0.113). In multivariate analysis using the Cox proportional hazards model, stage III CCA (hazard ratio [HR], 10.81; 95% confidence interval [CI], 2.92-40.00; p<0.001) was a significant predictor of OS. American Society of Anesthesiologists classification II (HR, 0.50; 95% CI, 0.31-0.81; p=0.005), and American Joint Committee on Cancer stages II (HR, 3.14; 95% CI, 1.25-7.89; p=0.015) and III (HR, 8.08; 95% CI, 2.80-23.32; p<0.001) were independent predictors of PFS. CONCLUSION: AT after R0 resection for CCA did not improve OS or PFS.

Outcome and safety of self-expandable metallic stents for malignant colon obstruction: a Korean multicenter randomized prospective study.

BACKGROUND: Newly developed uncovered stents are designed to have varied radial force and high conformability to improve clinical outcome and safety. This study aimed to determine and compare the clinical outcome and safety of the Taewoong D-type uncovered stent and the Boston Scientific Wallfex stent. METHODS: Patients with acute malignant colonic obstruction were treated with a colonic stent. For the purpose of palliation, patients were randomly allocated. For the purpose of bridging, the type of stent was determined by the discretion of the individual doctors. Technical and clinical success and complication occurrence were measured as primary outcomes. RESULTS: From 12 university hospitals, 123 patients with malignant colonic obstruction were enrolled. Of these 123 patients, 58 were treated with colonic stents for palliative purposes. The technical and clinical success rate was 100 % for both stents in the palliative group. Perforation occurred for one patient (3.6 %) in the Wallflex stent group (n = 28) on day 5 and for no patients in the D-type stent group (n = 30). Two cases of migration occurred: one with the Wallflex stent and one with the D-type stent. Stent restenosis occurred for one patient with the Wallflex stent. Preoperative bridging stents were placed in 65 patients. The median time to surgery was 10 days. The technical success rate was 93.4 %, and clinical success was achieved for 86.2 % of the patients. Perforation occurred for five patients: four with the Wallflex stent and one with the D-type stent. The efficacy and safety of the two stents did not differ statistically. CONCLUSIONS: The D-type colonic uncovered stent and the Wallflex colonic uncovered stent are effective and safe for both palliative and preoperative bridging therapy used to treat acute malignant colonic obstruction.