Predicting lymph node metastasis using preoperative parameters in patients with T1 ampulla of vater cancer.

BACKGROUND: Lymph node (LN) metastasis is an established prognostic factor for patients with surgically resected ampulla of Vater (AoV) cancer. The standard procedure for radical resection, including removal of regional LNs, is pancreaticoduodenectomy (PD); however, local excision has been considered as an alternative option for patients in the early stage cancer with significant comorbidities. In the present study, we elucidated the preoperative factors associated with LN metastasis to determine the appropriate surgical extent for T1 AoV cancer. METHODS: We included patients who underwent surgery for T1 AoV cancer at Samsung Medical Center and Severance Hospital between 2000 and 2019. Risk factors were analyzed to identify the preoperative parameters associated with LN metastasis or regional LN recurrence during follow-up. Finally, using the identified risk factors, a prediction model was constructed. RESULTS: Among 342 patients, 311 patients underwent PD, whereas 31 patients underwent transduodenal ampullectomy. Fourty-eight patients had LN metastasis according to pathology report, and two patients presented with regional LN recurrence. Age, carbohydrate antigen 19 - 9 (CA 19 - 9), and tumor differentiation were identified as factors associated with the increased risk of LN metastasis or regional LN recurrence. The area under the curve of the prediction model with these three factors was 0.728. CONCLUSION: Our newly developed prediction model using age, CA 19 - 9, and tumor differentiation can help select patients who require PD over local excision. Nevertheless, additional in-depth analysis is warranted to select appropriate surgical extent for patients with presumed T1 AoV cancer.

Surgical Outcomes of Pancreatectomy with Resection of the Portal Vein and/or Superior Mesenteric Vein and Jejunal Vein for Pancreatic Head Cancer: A Multicenter Study.

OBJECTIVE: The aim of this study was to investigate the safety and survival benefits of portal vein and/or superior mesenteric vein (PV/SMV) resection with jejunal vein resection (JVR) for pancreatic ductal adenocarcinoma (PDAC). SUMMARY BACKGROUND DATA: Few studies have shown the surgical outcome and survival of pancreatic resection with JVR, and treatment strategies for patients with PDAC suspected of jejunal vein (JV) infiltration remain unclear. METHODS: In total, 1260 patients who underwent pancreatectomy with PV/ SMV resection between 2013 and 2016 at 50 facilities were included; treatment outcomes were compared between the PV/SMV group (PV/ SMV resection without JVR; n = 824), PV/SMV-J1 V group (PV/SMV resection with first jejunal vein resection; n = 394), and PV/SMV-J2,3 V group (PV/SMV resection with second jejunal vein or later branch resection; n = 42). RESULTS: Postoperative complications and mortality did not differ between the three groups. The postoperative complication rate associated with PV/ SMV reconstruction was 11.9% in PV/SMV group, 8.6% in PV/SMV-J1 V group, and 7.1% in PV/SMV-J2,3V group; there were no significant differences among the three groups. Overall survival did not differ between PV/SMV and PV/SMV-J1 V groups (median survival; 29.2 vs 30.9 months, P = 0.60). Although PV/SMV-J2,3 V group had significantly shorter survival than PV/SMV group who underwent upfront surgery ( P = 0.05), no significant differences in overall survival of patients who received preoperative therapy. Multivariate survival analysis revealed that adjuvant therapy and R0 resection were independent prognostic factors in all groups. CONCLUSION: PV/SMV resection with JVR can be safely performed and may provide satisfactory overall survival with the pre-and postoperative adjuvant therapy.

Use of individualized 3D-printed models of pancreatic cancer to improve surgeons' anatomic understanding and surgical planning.

OBJECTIVES: Three-dimensional (3D) printing has been increasingly used to create accurate patient-specific 3D-printed models from medical imaging data. We aimed to evaluate the utility of 3D-printed models in the localization and understanding of pancreatic cancer for surgeons before pancreatic surgery. METHODS: Between March and September 2021, we prospectively enrolled 10 patients with suspected pancreatic cancer who were scheduled for surgery. We created an individualized 3D-printed model from preoperative CT images. Six surgeons (three staff and three residents) evaluated the CT images before and after the presentation of the 3D-printed model using a 7-item questionnaire (understanding of anatomy and pancreatic cancer [Q1-4], preoperative planning [Q5], and education for trainees or patients [Q6-7]) on a 5-point scale. Survey scores on Q1-5 before and after the presentation of the 3D-printed model were compared. Q6-7 assessed the 3D-printed model's effects on education compared to CT. Subgroup analysis was performed between staff and residents. RESULTS: After the 3D-printed model presentation, survey scores improved in all five questions (before 3.90 vs. after 4.56, p < 0.001), with a mean improvement of 0.57‒0.93. Staff and resident scores improved after a 3D-printed model presentation (p < 0.05), except for Q4 in the resident group. The mean difference was higher among the staff than among the residents (staff: 0.50‒0.97 vs. residents: 0.27‒0.90). The scores of the 3D-printed model for education were high (trainees: 4.47 vs. patients: 4.60) compared to CT. CONCLUSION: The 3D-printed model of pancreatic cancer improved surgeons' understanding of individual patients' pancreatic cancer and surgical planning. CLINICAL RELEVANCE STATEMENT: The 3D-printed model of pancreatic cancer can be created using a preoperative CT image, which not only assists surgeons in surgical planning but also serves as a valuable educational resource for patients and students. KEY POINTS: • A personalized 3D-printed pancreatic cancer model provides more intuitive information than CT, allowing surgeons to better visualize the tumor's location and relationship to neighboring organs. • In particular, the survey score was higher among staff who performed the surgery than among residents. • Individual patient pancreatic cancer models have the potential to be used for personalized patient education as well as resident education.

Propensity score matching analysis of perioperative outcomes including quality of life after multi-port vs. single port laparoscopic cholecystectomy: a nationwide prospective multicenter study in Korea.

INTRODUCTION: The usefulness of single-port laparoscopic cholecystectomy (SPLC) as compared to multi-port laparoscopic cholecystectomy (MPLC) remains controversial. Between SPLC and MPLC, we compared outcomes, especially subjective aspects, such as quality of life (QoL). MATERIAL AND METHODS: This multi-center study, involving 20 institutions from 2016 to 2017, enrolled 2507 patients who underwent laparoscopic cholecystectomy. Various perioperative outcomes, pain assessed by the numeric rating scale (NRS) score, and QoL evaluated by the gastrointestinal QoL index (GIQLI) questionnaire, were compared between the two procedures. We generated balanced groups after propensity score matching (PSM) using preoperative factors that influence the decision to perform MPLC or SPLC. RESULTS: MPLC and SPLC were performed in 2176 and 331 patients, respectively. Nine hundred and twelve and 329 patients, respectively, were selected from the two groups by PSM. Operation time was longer and surgical difficulty was lower in SPLC. There were no significant differences in most outcomes, including biliary complications. Significant superiority of SPLC over MPLC was shorter hospitalization, lower NRS score, and favorable GIQLI. CONCLUSIONS: From nationwide prospective data, SPLC showed outcomes comparable to MPLC. In SPLC, morbidity was not high and postoperative QoL was favorable. In the future, more implementations and studies are needed to ensure the safety and feasibility of SPLC.

Surgical outcomes and prognostic factors of distal common bile duct adenocarcinoma: chronological analysis in a single high-volume institutional experience.

BACKGROUND: Distal common bile duct (dCBD) cancer is typical indication for pancreaticoduodenectomy (PD). We aimed to retrospectively evaluate surgical outcomes and investigate prognostic factors of dCBD adenocarcinoma for which PD was performed at a single institution. METHODS: We searched consecutive cases of dCBD adenocarcinoma undergone PD at Samsung Medical Center from 1995 to 2018. Cases with distant metastasis or palliative intent were excluded. The year in which the survival rate was dramatically improved was identified and entire years were divided into two periods for comparison. To balance between the two periods, we conducted propensity score matching (PSM) analysis using age, sex, body mass index (BMI), and American Society of Anesthesiologist score. RESULTS: Total of 804 cases were enrolled in this study. The entire period was divided into early period of 18 years and recent period of 6 years. The early and late period included 466 and 338 patients, respectively. As a result of PSM, balanced 316 patients were selected from each of the two periods. Significant improvements in surgical outcomes were identified, including shorter operation time, fewer blood loss, shorter hospitalization, and favorable overall survival. As results of multivariable analysis of independent risk factors for overall survival, older age and advanced N stage were identified, as expected. It was distinct that aggressive surgery and advanced tumor state in the early period and a lower BMI in the late period negatively affected the survival, respectively. CONCLUSIONS: Surgical outcomes of dCBD cancer underwent PD was improved. There were few modifiable factors to improve survival and continuous further study is needed to detect dCBD cancer in the early stages.

Comparison of oncologic outcomes between open and laparoscopic distal pancreatectomy for pancreatic ductal adenocarcinoma using data from the KOTUS-BP national database: overcoming selection bias and the necessity of definite indications.

BACKGROUND: Despite the lack of high-level evidence, laparoscopic distal pancreatectomy (LDP) is frequently performed in patients with pancreatic ductal adenocarcinoma (PDAC) owing to advancements in surgical techniques. The aim of this study was to investigate the long-term oncologic outcomes of LDP in patients with PDAC via propensity score matching (PSM) analysis using data from a large-scale national database. METHODS: A total of 1202 patients who were treated for PDAC via distal pancreatectomy across 16 hospitals were included in the Korean Tumor Registry System-Biliary Pancreas. The 5-year overall (5YOSR) and disease-free (5YDFSR) survival rates were compared between LDP and open DP (ODP). RESULTS: ODP and LDP were performed in 846 and 356 patients, respectively. The ODP group included more aggressive surgeries with higher pathologic stage, R0 resection rate, and number of retrieved lymph nodes. After PSM, the 5YOSRs for ODP and LDP were 37.3% and 41.4% (p = 0.150), while the 5YDFSRs were 23.4% and 27.2% (p = 0.332), respectively. Prognostic factors for 5YOSR included R status, T stage, N stage, differentiation, and lymphovascular invasion. CONCLUSION: LDP was performed in a selected group of patients with PDAC. Within this group, long-term oncologic outcomes were comparable to those observed following ODP.

Minimally Invasive Versus Open Pancreatectomy for Right-Sided and Left-Sided G1/G2 Nonfunctioning Pancreatic Neuroendocrine Tumors: A Multicenter Matched Analysis with an Inverse Probability of Treatment-Weighting Method.

BACKGROUND: Limited evidence exists for the safety and oncologic efficacy of minimally invasive surgery (MIS) for nonfunctioning pancreatic neuroendocrine tumors (NF-PNETs) according to tumor location. This study aimed to compare the surgical outcomes of MIS and open surgery (OS) for right- or left-sided NF-PNETs. METHODS: The study collected data on patients who underwent surgical resection (pancreatoduodenectomy, distal/total/central pancreatectomy, duodenum-preserving pancreas head resection, or enucleation) of a localized NF-PNET between January 2000 and July 2017 at 14 institutions. The inverse probability of treatment-weighting method with propensity scores was used for analysis. RESULTS: The study enrolled 859 patients: 478 OS and 381 MIS patients. A matched analysis by tumor location showed no differences in resection margin, intraoperative blood loss, or complications between MIS and OS. However, MIS was associated with a longer operation time for right-sided tumors (393.3 vs 316.7 min; P < 0.001) and a shorter postoperative hospital stay for left-sided tumors (8.9 vs 12.9 days; P < 0.01). The MIS group was associated with significantly higher survival rates than the OS group for right- and left-sided tumors, but survival did not differ for the patients divided by tumor grade and location. Multivariable analysis showed that MIS did not affect survival for any tumor location. CONCLUSION: The short-term outcomes offered by MIS were comparable with those of OS except for a longer operation time for right-sided NF-PNETs. The oncologic outcomes were not compromised by MIS regardless of tumor location or grade. These findings suggest that MIS can be performed safely for selected patients with localized NF-PNETs.

Risk Factors for Recurrence in Pancreatic Neuroendocrine Tumor and Size as a Surrogate in Determining the Treatment Strategy: A Korean Nationwide Study.

INTRODUCTION: The prognostic factors of pancreatic neuroendocrine tumor (PNET) are unclear, and the treatment guidelines are insufficient. This study aimed to suggest a treatment algorithm for PNET based on risk factors for recurrence in a large cohort. METHODS: Data of 918 patients who underwent curative intent surgery for PNET were collected from 14 tertiary centers. Risk factors for recurrence and survival analyses were performed. RESULTS: The 5-year disease-free survival (DFS) rate was 86.5%. Risk factors for recurrence included margin status (R1, hazard ratio [HR] 2.438; R2, HR 3.721), 2010 WHO grade (G2, HR 3.864; G3, HR 7.352), and N category (N1, HR 2.273). A size of 2 cm was significant in the univariate analysis (HR 8.511) but not in the multivariate analysis (p = 0.407). Tumor size was not a risk factor for recurrence, but strongly reflected 2010 WHO grade and lymph node (LN) status. Tumors ≤2 cm had lower 2010 WHO grade, less LN metastasis (p < 0.001), and significantly longer 5-year DFS (77.9 vs. 98.2%, p < 0.001) than tumors >2 cm. The clinicopathologic features of tumors <1 and 1-2 cm were similar. However, the LN metastasis rate was 10.3% in 1-2-cm sized tumors and recurrence occurred in 3.0%. Tumors <1 cm in size did not have any LN metastasis or recurrence. DISCUSSION/CONCLUSION: Radical surgery is needed in suspected LN metastasis or G3 PNET or tumors >2 cm. Surveillance for <1-cm PNETs should be sufficient. Tumors sized 1-2 cm require limited surgery with LN resection, but should be converted to radical surgery in cases of doubtful margins or LN metastasis.

Optimal stapler cartridge selection to reduce post-operative pancreatic fistula according to the pancreatic characteristics in stapler closure distal pancreatectomy.

BACKGROUND: Postoperative pancreatic fistula (POPF) is associated with potentially fatal complications, but there is lack of data on relationship between pancreas thickness, and stapler size and the POPF rate. This study aimed to suggest optimal stapler that reduces POPF rate according to the pancreas thickness. METHODS: This retrospective cohort study was conducted in two tertiary high-volume pancreas centers. 599 patients who underwent distal pancreatectomy were assessed for stump reinforcement methods, pathology findings, pancreas thickness, and cartridge used. The cartridges were grouped as I, II, III according to the closed height ≤1.5 mm, 1.8 mm, and ≥2.0 mm, respectively. RESULTS: The POPF rate increased according to the thickness. The stapler Groups I, II, and III had an overall POPF rate of 66.4% vs. 61.7% vs. 57.8%, but Group II stapler cartridge showed a significant reduction in the POPF rate than other cartridges in pancreas with thickness <13 mm (53.5% vs. 21.7% vs. 36.0%, p = 0.031). There was no significant difference between the POPF rate according to stapler groups when the pancreas was thicker than 13 mm. CONCLUSION: Thickness is the strongest risk factor in predicting POPF. Use of Group II stapler cartridge for pancreas with a thickness of <13 mm can help reduce POPF.

Propensity score-matched analysis of internal stent vs external stent for pancreatojejunostomy during pancreaticoduodenectomy: Japanese-Korean cooperative project.

BACKGROUND: Several studies comparing internal and external stents have been conducted with the aim of reducing pancreatic fistula after PD. There is still no consensus, however, on the appropriate use of pancreatic stents for prevention of pancreatic fistula. This multicenter large cohort study aims to evaluate whether internal or external pancreatic stents are more effective in reduction of clinically relevant pancreatic fistula after pancreaticoduodenectomy (PD). METHODS: We reviewed 3149 patients (internal stent n = 1,311, external stent n = 1838) who underwent PD at 20 institutions in Japan and Korea between 2007 and 2013. Propensity score matched analysis was used to minimize bias from nonrandomized treatment assignment. The primary endpoint was the incidence of clinically relevant pancreatic fistula. This study was registered on the UMIN Clinical Trials Registry (UMIN000032402). RESULTS: After propensity score matched analysis, clinically relevant pancreatic fistula occurred in more patients in the external stents group (280 patients, 28.7%) than in patients in the internal stents group (126 patients, 12.9%) (OR 2.713 [95% CI, 2.139-3.455]; P < 0.001). In subset analysis of a high-risk group with soft pancreas and no dilatation of the pancreatic duct, clinically relevant pancreatic fistula occurred in 90 patients (18.8%) in internal stents group and 183 patients (35.4%) in external stents group. External stents were significantly associated with increased risk for clinically relevant pancreatic fistula (OR 2.366 [95% CI, 1.753-3.209]; P < 0.001). CONCLUSION: Propensity score matched analysis showed that, regarding clinically relevant pancreatic fistula after PD, internal stents are safer than external stents for pancreaticojejunostomy.

Comparative study of laparoscopic versus open technique for simultaneous resection of colorectal cancer and liver metastases with propensity score analysis.

BACKGROUND: Laparoscopic liver resection for metastatic colorectal cancer (CRC) remains controversial. The objective of this study was to compare the short-term and mid-term outcomes of patients with CRC undergoing laparoscopic versus open colorectal resection with simultaneous resection for liver metastases. METHODS: A total of 126 patients underwent combined laparoscopic resection of CRC and synchronous colorectal liver metastases between 2008 and 2016. A total of 318 patients were treated by an open approach during the above period. By propensity score matching, 109 patients who underwent laparoscopic resection and 109 patients who had an open approach were compared. Analyzed variables included patient characteristics, tumor features, and short-term and mid-term outcomes. RESULTS: Demographic features and pathologic outcomes were similar in both groups after propensity score matching. Three (2.8%) patients undergoing laparoscopic liver resection experienced conversion to open procedure. There was no difference in hospital stay (p = 0.078), transfusion rate (p = 0.686), or time of bowel function return (p = 0.570) between the two groups. The laparoscopic group and the open approach group also showed similar 3-year overall survival rate (74.4% vs. 79.1%; p = 0.792) and 3-year disease-free survival rate (58.5% vs. 55.2%; p = 0.391). However, postoperative morbidity rate was significantly lower in the laparoscopic group (20.2% vs. 33.0%; p = 0.032). CONCLUSIONS: Laparoscopic colorectal resection with simultaneous resection of liver metastases showed satisfactory oncologic outcomes with some short-term advantages compared to the open approach. Thus, laparoscopic approach could be a good alternative of open approach for simultaneous liver and colon resection in patients with CRC.

Prognostic Impact of Intra-Ampullary Papillary-Tubular Neoplasm versus Flat Dysplasia as Precursor Lesions of Ampullary Adenocarcinoma.

BACKGROUND: The aim of this study is to compare the prognostic impact of 2 precursor lesions of ampullary adenocarcinoma, intra-ampullary papillary-tubular neoplasm (IAPN) and flat dysplasia (FD). METHODS: From December 1994 to December 2012, a total of 359 patients underwent curative surgery for ampullary adenocarcinoma. RESULTS: The precursor lesions were IAPNs in 134 (37.3%) patients and FD in the other 225 (62.7%) patients. The FD group had more aggressive tumor biology with advanced T stage (p = 0.002), nodal involvement (p < 0.001), poor differentiation (p < 0.001), perineural and lymphovascular invasion (p < 0.001), and pancreatobiliary or mixed subtype (p < 0.001). Five-year overall survival rates were 71.1% in the IAPN group and 51.4% in the FD group (p = 0.002), respectively. Five-year disease-free survival rates were 69.7% in the IAPN group and 49.6% in the FD group (p < 0.001), respectively. The recurrence rate was also higher in the FD group (49.8 vs. 30.6%; p < 0.001). On multivariate analysis, higher levels of tumor markers including CEA and CA19-9, lymph node metastasis, poorly differentiated histology, and perineural invasion were negative predictive factors for survival. Higher levels of CEA and CA19-9, lymphovascular invasion, and FD were independent prognostic factors for recurrence. CONCLUSION: FD was significantly associated with worse prognosis and a greater tendency toward advanced disease. Further studies are needed to clarify the impacts of these precursor lesions.

Oncological Benefits of Neoadjuvant Chemoradiation With Gemcitabine Versus Upfront Surgery in Patients With Borderline Resectable Pancreatic Cancer: A Prospective, Randomized, Open-label, Multicenter Phase 2/3 Trial.

OBJECTIVE: This study was performed to determine whether neoadjuvant treatment increases survival in patients with BRPC. SUMMARY BACKGROUND DATA: Despite many promising retrospective data on the effect of neoadjuvant treatment for borderline resectable pancreatic cancer (BRPC), no high-level evidence exists to support the role of such treatment. METHODS: This phase 2/3 multicenter randomized controlled trial was designed to enroll 110 patients with BRPC who were randomly assigned to gemcitabine-based neoadjuvant chemoradiation treatment (54 Gray external beam radiation) followed by surgery or upfront surgery followed by chemoradiation treatment from four large-volume centers in Korea. The primary endpoint was the 2-year survival rate (2-YSR). Interim analysis was planned at the time of 50% case enrollment. RESULTS: After excluding the patients who withdrew consent (n = 8) from the 58 enrolled patients, 27 patients were allocated to neoadjuvant treatment and 23 to upfront surgery groups. The overall 2-YSR was 34.0% with a median survival of 16 months. In the intention-to-treat analysis, the 2-YSR and median survival were significantly better in the neoadjuvant chemoradiation than the upfront surgery group [40.7%, 21 months vs 26.1%, 12 months, hazard ratio 1.495 (95% confidence interval 0.66-3.36), P = 0.028]. R0 resection rate was also significantly higher in the neoadjuvant chemoradiation group than upfront surgery (n = 14, 51.8% vs n = 6, 26.1%, P = 0.004). The safety monitoring committee decided on early termination of the study on the basis of the statistical significance of neoadjuvant treatment efficacy. CONCLUSION: This is the first prospective randomized controlled trial on the oncological benefits of neoadjuvant treatment in BRPC. Compared to upfront surgery, neoadjuvant chemoradiation provides oncological benefits in patients with BRPC.

Laparoscopic versus open distal pancreatectomy for nonfunctioning pancreatic neuroendocrine tumors: a large single-center study.

BACKGROUND: Pancreatic neuroendocrine tumors (PNETs) account for 1-2% of all pancreatic neoplasms. Nonfunctioning PNETs (NF-PNETs) account for 60-90% of all PNETs. Laparoscopic distal pancreatectomy (LDP) is becoming the treatment of choice for benign lesions in the body and tail of the pancreas. However, LDP has not yet been widely accepted as the gold standard for NF-PNETs. The purpose of this study is to evaluate the clinical and oncologic outcomes after laparoscopic versus open distal pancreatectomy (ODP) for NF-PNETs. METHODS: Between April 1995 and September 2016, 94 patients with NF-PNETs underwent open or laparoscopic distal pancreatectomy at Samsung Medical Center. Patients were divided into two groups: those who underwent LDP and those who underwent ODP. Both groups were compared in terms of clinical and oncologic variables. RESULTS: LDP patients had a significantly shorter hospital stay compared with ODP patients, amounting to a mean difference of 2 days (p < 0.001). Overall complication rates did not differ significantly between the ODP and LDP groups (p = 0.379). The 3-year overall survival rates in the ODP and LDP groups were 93.7 and 100%, respectively (p = 0.069). CONCLUSIONS: In this study, LDP for NF-PNETs had similar oncologic outcomes compared with ODP. In addition, LDP was associated with a shorter hospital stay compared with ODP. Therefore, LDP is a safe and effective procedure for patients with NF-PNETs. A multicenter study and a randomized controlled trial are needed to better assess the clinical and oncologic outcomes.

Proposed Nomogram Predicting the Individual Risk of Malignancy in the Patients With Branch Duct Type Intraductal Papillary Mucinous Neoplasms of the Pancreas.

OBJECTIVES: This study evaluated individual risks of malignancy and proposed a nomogram for predicting malignancy of branch duct type intraductal papillary mucinous neoplasms (BD-IPMNs) using the large database for IPMN. BACKGROUND: Although consensus guidelines list several malignancy predicting factors in patients with BD-IPMN, those variables have different predictability and individual quantitative prediction of malignancy risk is limited. METHODS: Clinicopathological factors predictive of malignancy were retrospectively analyzed in 2525 patients with biopsy proven BD-IPMN at 22 tertiary hospitals in Korea and Japan. The patients with main duct dilatation >10 mm and inaccurate information were excluded. RESULTS: The study cohort consisted of 2258 patients. Malignant IPMNs were defined as those with high grade dysplasia and associated invasive carcinoma. Of 2258 patients, 986 (43.7%) had low, 443 (19.6%) had intermediate, 398 (17.6%) had high grade dysplasia, and 431 (19.1%) had invasive carcinoma. To construct and validate the nomogram, patients were randomly allocated into training and validation sets, with fixed ratios of benign and malignant lesions. Multiple logistic regression analysis resulted in five variables (cyst size, duct dilatation, mural nodule, serum CA19-9, and CEA) being selected to construct the nomogram. In the validation set, this nomogram showed excellent discrimination power through a 1000 times bootstrapped calibration test. CONCLUSION: A nomogram predicting malignancy in patients with BD-IPMN was constructed using a logistic regression model. This nomogram may be useful in identifying patients at risk of malignancy and for selecting optimal treatment methods. The nomogram is freely available at http://statgen.snu.ac.kr/software/nomogramIPMN.

Clinical Application of Targeted Deep Sequencing in Solid-Cancer Patients and Utility for Biomarker-Selected Clinical Trials.

Molecular profiling of actionable mutations in refractory cancer patients has the potential to enable "precision medicine," wherein individualized therapies are guided based on genomic profiling. The molecular-screening program was intended to route participants to different candidate drugs in trials based on clinical-sequencing reports. In this screening program, we used a custom target-enrichment panel consisting of cancer-related genes to interrogate single-nucleotide variants, insertions and deletions, copy number variants, and a subset of gene fusions. From August 2014 through April 2015, 654 patients consented to participate in the program at Samsung Medical Center. Of these patients, 588 passed the quality control process for the 381-gene cancer-panel test, and 418 patients were included in the final analysis as being eligible for any anticancer treatment (127 gastric cancer, 122 colorectal cancer, 62 pancreatic/biliary tract cancer, 67 sarcoma/other cancer, and 40 genitourinary cancer patients). Of the 418 patients, 55 (12%) harbored a biomarker that guided them to a biomarker-selected clinical trial, and 184 (44%) patients harbored at least one genomic alteration that was potentially targetable. This study demonstrated that the panel-based sequencing program resulted in an increased rate of trial enrollment of metastatic cancer patients into biomarker-selected clinical trials. Given the expanding list of biomarker-selected trials, the guidance percentage to matched trials is anticipated to increase. IMPLICATIONS FOR PRACTICE: This study demonstrated that the panel-based sequencing program resulted in an increased rate of trial enrollment of metastatic cancer patients into biomarker-selected clinical trials. Given the expanding list of biomarker-selected trials, the guidance percentage to matched trials is anticipated to increase.

Predictive factors of gastroduodenal bleeding after postoperative radiotherapy in biliary tract cancer.

OBJECTIVE: To identify predictive factors for gastroduodenal bleeding after postoperative radiation therapy in patients with biliary tract cancer. METHODS: We identified 186 patients with biliary tract cancer who completed scheduled postoperative radiation therapy from March 2000 to August 2013. To isolate the effects of radiation on gastroduodenal bleeding, patients with pylorus-preserving pancreaticoduodenectomy, pylorus-resecting pancreaticoduodenectomy or Whipple surgery (n = 67) were excluded from this analysis. Postoperative radiation therapy was started at a median 5 weeks (range: 4-12 weeks) after surgery with a median dose of 44 Gy (range: 44-54), and chemotherapy was also concurrently administered to 102 patients. RESULTS: The median age of the patients was 59 years (range: 36-76 years). Of the 119 patients, 26 had intrahepatic cholangiocarcinoma, 29 had hilar cholangiocarcinoma, while 64 had extrahepatic tumors (gallbladder cancer, n = 53; proximal bile duct cancer, n = 10; choledochal cyst cancer, n = 1). Of all, 11 patients (9%) developed gastroduodenal bleeding. In univariate analyses, hepatic artery resection and gastroduodenal wall thickening on postoperative radiation therapy simulation computed tomography were statistically significant factors for gastroduodenal bleeding. Multivariate analysis by a logistic regression model using those two variables revealed that both parameters were independent predictors for gastroduodenal bleeding. CONCLUSIONS: Concomitant hepatic artery resection and presence of gastroduodenal wall thickening on postoperative radiation therapy simulation computed tomography were predictive factors for gastroduodenal bleeding after postoperative radiation therapy in biliary tract cancer. In such cases, patients should be informed of the high risk of gastroduodenal bleeding, and should be closely observed during and after postoperative radiation therapy.

The impact of KRAS mutations on prognosis in surgically resected colorectal cancer patients with liver and lung metastases: a retrospective analysis.

BACKGROUND: KRAS mutations are common in colorectal cancer (CRC). The role of KRAS mutation status as a prognostic factor remains controversial, and most large population-based cohorts usually consist of patients with non-metastatic CRC. We evaluated the impact of KRAS mutations on the time to recurrence (TTR) and overall survival (OS) in patients with metastatic CRC who underwent curative surgery with perioperative chemotherapy. METHODS: Patients who underwent curative resection for primary and synchronous metastases were retrospectively collected in a single institution during a 6 year period between January 2008 and June 2014. Patients with positive surgical margins, those with known BRAF mutation, or those with an unknown KRAS mutation status were excluded, and a total of 82 cases were identified. The pathological and clinical features were evaluated. Patients' outcome with KRAS mutation status for TTR and OS were investigated by univariate and multivariate analysis. RESULTS: KRAS mutations were identified in 37.8% of the patients and not associated with TTR or OS between KRAS wild type and KRAS mutation cohorts (log-rank p = 0.425 for TTR; log-rank p = 0.137 for OS). When patients were further subdivided into three groups according to mutation subtype (wild-type vs. KRAS codon 12 mutation vs. KRAS codon 13 mutation) or amino acid missense mutation type (G > A vs. G > T vs. G > C), there were no significant differences in TTR or OS. Mutational frequencies were significantly higher in patients with lung metastases compared with those with liver and ovary/bladder metastases (p = 0.039), however, KRAS mutation status was not associated with an increased risk of relapsed in the lung. CONCLUSIONS: KRAS mutation was not associated with TTR or OS in patients with metastatic CRC who underwent curative surgery with perioperative chemotherapy.

Transduodenal Ampullectomy for the Treatment of Early-Stage Ampulla of Vater Cancer.

BACKGROUND: Transduodenal ampullectomy (TDA) is a less invasive procedure than pancreaticoduodenectomy (PD). However, the outcomes of TDA and PD have been compared rarely in early ampullary cancer. METHODS: From September 1994 to June 2013, the patients who underwent curative surgery for Tis or T1 ampulla of Vater neoplasm were identified. The patients were divided into two groups according to the types of surgery; TDA group and PD group. The patient characteristics and survival outcomes were retrospectively investigated between the two groups. RESULTS: Total 137 patients were included in this study. The 18 patients underwent TDA and 119 patients underwent PD for Tis or T1 ampullary cancer. There was no lymph node metastasis in the patients with Tis tumor although 10 of 104 patients had lymph node metastasis in T1 cancer. After a median follow-up of 50 months (range, 6-148), there were no recurrence after TDA for Tis tumor. However, the TDA was associated with higher local recurrence rate than PD in the patients with T1 ampullary cancer on Kaplan-Meier survival analysis (p = 0.007). CONCLUSION: The TDA is feasible treatment for Tis ampulla of Vater neoplasm. However, TDA is unsuitable for the treatment of T1 ampulla of Vater cancer.

Prognostic factors after pulmonary metastasectomy of colorectal cancers: influence of liver metastasis.

BACKGROUND: Our objective was to evaluate the influence of liver metastasis on survival after pulmonary metastasectomy in patients with colorectal cancer (CRC). METHODS: We retrospectively reviewed a total of 524 patients and were classified into two groups based on the presence of liver metastasis. Group HM + PM (n = 106) included patients who previously received a hepatic metastasectomy and then received pulmonary metastasectomy. Group PM (n = 418) included patients who only received pulmonary metastasectomy with no liver metastasis. RESULTS: There were more male patients (70 vs. 57 %; P = 0.02) and more patients with colon cancer (60 vs. 42 %, P = 0.001) in group HM + PM than in group PM. Otherwise, there was no significant difference between the two groups in clinicopathologic characteristics and extent of surgery. The 5-year overall survival (OS) and disease-free survival (DFS) rates were 58 and 31 %, respectively. There was no significant difference in OS (group HM + PM, 54 % vs. group PM, 59 %; P = 0.085) and in DFS (group HM + PM, 28 % vs. group PM, 32 %; P = 0.12). For the entire patient cohort, a multivariate analysis revealed that the presence of liver metastasis, CRC T and N stages, disease-free interval, and number and size of lung metastases were significantly associated with OS and DFS. CONCLUSIONS: Our findings suggest that previous or present liver metastasis should not exclude a patient from pulmonary metastasectomy. When lung metastasis is detected in patients with a history of hepatic metastasectomy, pulmonary metastasectomy is still a viable treatment option especially in patients with a long disease-free interval and a small number of lung metastases.