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Purpose: Mesenteric panniculitis (MP) represents the uncommon, benign and chronic inflammatory disorder affecting the mesenteric adipose tissues. Its etiology, diagnosis and treatment remain unnoticed. Our report focused on shedding more lights on this condition. Patients and methods: Seventeen MP patients were identified by searching the electronic medical record system in the Zhengzhou Ninth People's Hospital using the search terms "Mesenteric panniculitis" from October 2015 to March 2023. All cases were diagnosed with MP through computed tomography (CT). Their clinical features and treatments were analyzed. Results: There were altogether 17 cases enrolled for this analysis. The male to female ratio was 8:9, and the median age at diagnosis was 64 (range: 37–96) years. There were 15 patients (88.2%) showing abdominal pain to varying degrees. The proportions of symptoms of nausea, vomiting and fever were 23.5%, 23.5% and 41.2%, respectively. Neoplastic disease was present in 3 patients (17.6%). Meanwhile, 9 patients (52.9%) had gallstones, 3 (17.6%) had cholecystitis and 1 (5.9%) had gallbladder polyps. Six patients (35.3%) received antibiotics treatment only and 1 (5.9%) received oral antibiotics and prednisone. One patient (5.9%) received antibiotics followed by prednisone treatment, because the symptoms were significantly relieved after antibiotic treatment, while the disease recurred soon after, and the symptoms improved again after prednisone treatment. The abdominal pain in 9 patients (52.9%) was relieved spontaneously. Two patients (11.8%) died, including one due to respiratory failure caused by pneumonia and the other one because of pancreatic cancer with lung and liver metastases. Conclusion: MP is a poorly understood chronic inflammatory disease. Patients often have abdominal pain as the main symptom, accompanied by comorbidities in the gallbladder, and the prognosis is usually good after correct diagnosis and treatment, Therefore, the present report aims to promote the awareness among clinicians of patients with non-classic abdominal symptoms, so as to avoid misdiagnosis or missed diagnosis. [ABSTRACT FROM AUTHOR]

Background: The relationship between adenomyomatous hyperplasia of the Vaterian system(AV) and cancer is unclear, some reports suggest that AV is often combined with mucosal glandular dysplasia, but it is not clear whether mucosal glandular dysplasia is a risk factor for carcinogenesis of AV. The aim of this study was to retrospective analysis of role of ductal glandular dysplasia as a risk factor in the development of carcinoma in AV. Methods: A total of 328 cases who underwent surgery with a final pathological diagnosis of adenomyomatous hyperplasia (AH) in the Chinese PLA General Hospital in BeiJing, China, between January 2005 and December 2021 were retrospectively collected. There were Seventeen cases(5%) in which the lesions were located in the common bile duct as well as the ampulla of Vater, and their clinical (age, sex, etc.), imaging (cholelithiasis, etc.) and pathological data (mucosal glandular dysplasia, etc.) were collected. Clinical data and pathological features of AV with or without mucosal glandular dysplasia were analyzed. Results: There were 17 out of 328 cases of AH occurring in the Vaterian system (5%). Three of seventeen AV cases were associated with carcinoma (18%). Of three cases, two (12%) with the tumor lesions in the mucosal glands adjacent to the AH (biliary tract cancer and ampullary cancer), and one (6%) with carcinoma developed from AH itself in the ampulla of Vater. All carcinomas had adenomyomatous hyperplasia with nearby mucosal glandular dysplasia (MGD). The percentage of BTC or AC was higher in patients with concurrent AH and MGD compared to AH patients without MGD. The results show tendency toward statistical significance (P = 0.082). This difference was more obvious among AH with severe dysplasia compared to adenomyomatous hyperplasia with mild-moderate dysplasia (P = 0.018). Conclusion: This study is the first to find that AV is associated with biliary tract cancer and ampullary cancer. In AV, the mucosal glandular dysplasia may be a risk factor for the development of malignancy. The underlying mechanism for carcinogenesis of AV could be AH itself or its secretions stimulating mucosal glands hyperplasia, then mucosal glands dysplasia. AV may be a precancerous lesion. [ABSTRACT FROM AUTHOR]

Purposes: The current study was performed to comparatively evaluate the similarities and differences between cases with radically re-resected incidental gallbladder carcinoma (RRIGBC) and those with primary radically resected gallbladder carcinoma (PRGBC). Methods: Comparative analysis between patients with RRIGBC and those with PRGBC were performed in terms of clinic-pathological features and long-terms survival. Results: A total of 330 surgically treated GBC patients with 110 patients with IGBC were identified. PRGBCs were generally in a more advanced tumor stage, sharing more aggressive tumor biological features and worse prognosis than those with RRIGBC. Subgroup analyses indicated a comparable prognosis among T1-2 patients between RRIGBC and PRGBC groups. However, among T3-4 patients, patients in the PRGBC group shared a much worse prognosis. Moreover, IGBC itself can be regarded as a prognostic factor but cannot be regarded as an independent prognostic factor. It is the tumor stage which really determined the overall prognosis. Conclusion: Patients with RRIGBC were generally in a much earlier tumor stage and shared a much better prognosis than those with PRGBC. IGBC itself can be regarded as a prognostic factor but cannot be regarded as the independent prognostic factors. It is the tumor stage which really determine the overall prognosis. [ABSTRACT FROM AUTHOR]

Background: Gallbladder cancer (GC) is a uncommon and highly malignant tumor. This study compared the effects of simple cholecystectomy (SC) and extended cholecystectomy (EC) on the long-term survival of stage I GC. Methods: Patients with stage I GC between 2004 and 2015 in the SEER database were selected. Meanwhile, this study collected the clinical information of patients with stage I GC admitted to five medical centers in China between 2012 and 2022. Using clinical data from patients in the SEER database as a training set to construct a nomogram, which was validated in Chinese multicenter patients. Long-term survival between SC and EC were distinguished using propensity score matching (PSM). Results: A total of 956 patients from the SEER database and 82 patients from five Chinese hospitals were included in this study. The independent prognostic factors were age, sex, histology, tumor size, T stage, grade, chemotherapy and surgical approach by multivariate Cox regression analysis. We developed a nomogram based on these variables. The nomogram has been proved to have good accuracy and discrimination in internal and external validation. The cancer-specific survival (CSS) and overall survival of patients receiving EC were better than those of SC before and after the propensity score match. The interaction test showed that EC was associated with better survival in patients aged ≥ 67 years (P = 0.015) and in patients with T1b and T1NOS (P < 0.001). Conclusion: A novel nomogram to predict CSS in patients with stage I GC after SC or EC. Compared with SC, EC for stage I GC had higher OS and CSS, especially in specific subgroups (T1b, T1NOS, and age ≥ 67 years). [ABSTRACT FROM AUTHOR]

Background: Biliary tract cancer (BTC) is a malignancy associated with unfavorable outcomes. Advanced BTC patients have a propensity to experience compromised immune and nutritional status as a result of obstructive jaundice and biliary inflammation. Currently, there is a lack of consensus on the impact of the Controlling Nutritional Status (CONUT) score in the context of BTC prognosis. The purpose of this study is to conduct a meta-analysis on the association between CONUT and the prognosis of patients suffering from BTC. Methods: A defined search strategy was implemented to search the PubMed, Embase, and Web of Science databases for eligible studies published until March 2023, with a focus on overall survival (OS), relapse-free survival/recurrence-free survival(RFS), and relevant clinical characteristics. The prognostic potential of the CONUT score was evaluated using hazard ratios (HRs) or odds ratios (ORs) with 95% confidence intervals (CIs). Results: In this meta-analysis, a total of 1409 patients from China and Japan were involved in 9 studies. The results indicated that the CONUT score was significantly correlated with worse OS (HR=2.13, 95% CI 1.61-2.82, P<0.0001) and RFS (HR=1.83, 95% CI 1.44–2.31, P<0.0001) in patients with BTC. And, the analysis showed that a high CONUT score was significantly associated with clinical characteristics such as jaundice (OR=1.60, 95% CI=1.14–2.25, P=0.006), poorly differentiated tumor (OR=1.43, 95% CI=1.03–1.99, P=0.03), pT3 and 4 stage of the tumor (OR=1.87, 95% CI=1.30–2.68, P=0.0007), and complications of Clavien-Dindo classification grade IIIa or higher (OR=1.79, 95% CI=1.03–3.12, P=0.04). Conclusion: This meta-analysis indicates that a high CONUT score can serve as a significant prognostic indicator for survival outcomes among patients diagnosed with BTC. [ABSTRACT FROM AUTHOR]

Background: Biliary tract cancer (BTC) is a relatively rare but highly aggressive malignancy. However, there is currently no satisfactory second-line regimen for patients without specific genetic mutations. Nanoparticle albumin–bound paclitaxel, also known as nab-paclitaxel (Abraxane, Bristol Myers Squibb), has shown activity in patients with BTC. Studies investigating the immunogenic features of BTC suggested that checkpoint inhibition may lead to antitumor immune responses. In recent years, improved survival has been observed in patients treated with chemotherapy combined with immunotherapy across multiple cancer types, including BTC. This clinical trial aims to evaluate the efficacy and safety of second-line sintilimab in combination with nab-paclitaxel in advanced BTC patients. Methods: The NapaSinti trial is a prospective, nonrandomized, open-label, phase 2 study conducted at a tertiary hospital in Chengdu, China. Eligible patients are those with histologically or cytologically confirmed locally advanced non-resectable or metastatic adenocarcinoma in the biliary tract (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer), aged between 18 and 75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, who have experienced disease progression after prior gemcitabine- or fluorouracil-based chemotherapy and have not received taxane or immune checkpoint inhibitor treatment. Enrolled patients will receive intravenous administration of sintilimab 200 mg on day 1 and nab-paclitaxel 125 mg/m2 on days 1 and 8, every three weeks. The primary endpoint is the objective response rate (ORR), while the secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety. Exploratory objectives aim to identify biomarkers and molecular signatures for predicting response or prognosis. Using Simon's two-stage design, a total of 63 participants will be enrolled in the study. This trial was initiated in March 2022 in China. Discussion: The NapaSinti trial evaluates the efficacy and safety of second-line sintilimab plus nab-paclitaxel for advanced biliary tract cancer. Additionally, the trial provides an opportunity for translational research. Trial registration: Chinese Clinical Trial Registry ChiCTR2100052118. Registered October 19, 2021. [ABSTRACT FROM AUTHOR]

Introduction: IgG4-related disease (IgG4-RD) mimics a variety of disorders, the final diagnosis is heavily dependent on the doctor's familiarity with the disease, most patients are expected to get a good prognosis by early diagnosis and timely treatment. Methods: Retrospective analysis was carried out on 147 patients tested for serum IgG4 because of suspected IgG4-RD. These cases were grouped as the IgG4-RD group and non-IgG4-RD group according to the diagnostic criteria proposed by the Japanese IgG4-RD research group and the American College of Rheumatology and the European Union of Rheumatology. Characteristics of these patients were investigated and analyzed. Results: The onset age of IgG4-RD was 57.29 ± 14.03 years old, male to female ratio of IgG4-RD was 1.31:1. The most commonly affected organs were the pancreas (48.6%), lymph nodes (40.5%) and biliary tract (35.1%), the proportion of patients with simultaneous involvement of multiple organs is as high as 83.2%. A history of allergy is more common in IgG4-RD patients (32.4% vs 14.5%), the optimal critical value of serum IgG4/IgG ratio for diagnosis of IgG4-RD was 0.09 (sensitivity 94.7%, specificity 91.7%) and the optimal threshold for IgG diagnosis of IgG4-RD was 15.25g/L (sensitivity 73.7%, specificity 77.8%) in this study. Conclusion: IgG4-RD is often manifested as multiple organ involvement, and is most likely to involve the pancreas, biliary tract and lymph nodes. Most patients were diagnosed in other departments instead of rheumatology. Serum IgG4 level, especially IgG4/IgG ratio has a higher predictive value for IgG4-RD. Early diagnosis is the key point to improve the prognosis. [ABSTRACT FROM AUTHOR]

Background: Currently, no second-line systemic treatment regimen has been recommended in advanced biliary tract cancer (BTC). Cumulative clinical evidence showed that systemic treatment with tyrosine kinase inhibitors (TKIs) in combination with immunotherapy may shed light on the dim clinical outcome in advanced BTC. Objective: The aim of this study is to evaluate the anticancer efficacy of lenvatinib plus programmed cell death protein-1 (PD-1) antibody in patients with BTC who progressed after first-line cisplatin/gemcitabine (CisGem) chemotherapy. Methods: Patients with advanced BTCs who progressed after CisGem were recruited. A combination regimen of lenvatinib (8/12 mg daily) plus PD-1 antibody (200/240 mg injection every 3 weeks) was prescribed. Clinicopathological information and therapeutic outcome, including tumor subtypes, biomarkers, treatment duration, adverse events (AE), progression-free survival (PFS), and overall survival (OS), were recorded and estimated. Results: A total of 351 patients with BTCs were reviewed and 74 were recruited eventually: 35 had intrahepatic cholangiocarcinoma (47.3%), 4 had extrahepatic cholangiocarcinoma (5.4%), and 35 had gallbladder cancer (47.3%). The median administered cycles of PD-1 antibody were 6.43 (95% CI: 5.83-7.04) cycles, and the median duration of lenvatinib medication was 21.0 weeks (95% CI: 18.04-23.93). Twenty-eight patients (37.83%) experienced detectable objective response per RECIST1.1 within a median follow-up duration of 15.0 months. The objective response rate (ORR) was 20.27% (95% CI: 10.89%-29.65%), and the disease control rate (DCR) was 71.62% (95% CI: 61.11%-82.14%). The median PFS and OS were 4.0 months (95% CI: 3.5-5.0) and 9.50 months (95% CI: 9.0-11.0), respectively. Seventy-three patients (98.64%) reported AEs and 39 (52.70%) experienced =grade 3 AEs. In subgroup analyses, tumoral PD-L1 expression =50% and tumor mutation burden (TMB) =2.5 Muts/Mb were associated with prolonged PFS. Conclusion: Lenvatinib plus PD-1 antibody treatment shows an active trend towards improving survival in patients with advanced BTCs after failure with CisGem chemotherapy. The treatment-related AEs are worthy of attention and are manageable. [ABSTRACT FROM AUTHOR]

Gallbladder cancer (GBC) is one of the lethal cancers with an extremely poor prognosis. In the recent 20 years, research on GBC has developed rapidly. Here we aim to perform a systematical bibliometric analysis on the current foci and status of GBC research. This study analyzes trends in GBC research and compares contributions from different countries and regions, institutions, and authors. All publications in GBC research from 2001 to 2021 in the Web of Science Core Collection (WoSCC) database were collected. Microsoft Excel 2010 and GraphPad Prism 9 were used to analyze publication data and publication trends. VOSviewer 1.6.17 was adapted to generate a visual network of keywords in surgical training research. A total of 3,323 publications were included. China was the most productive country, with the highest number of publications (n = 900, 27.08%). Shanghai Jiaotong University and Roa JC were the most productive institution and authors, contributing 215 and 89 publications, respectively. Keywords were classified into five clusters, each representing a key topic. The main clusters of GBC are related to surgery therapy, mechanism research-related study, and non-surgery therapy, while migration is the current hotspot of GBC research. The scientific progression of GBC research over the past two decades was comprehensively analyzed by this bibliometric study. Finding deeper mechanisms in the migration of GBC cells, new biomarkers, and highly effective nomograms will be the major problems and directions in the future. [ABSTRACT FROM AUTHOR]

Background: The association between marital status and gallbladder cancer (GBC) remains uncertain. This study aimed to verify the relationship between marital status and GBC and construct a prognostic nomogram to predict the impact of marital status on GBC patients., Method: GBC patients were divided into married and unmarried groups using data from the Surveillance, Epidemiology, and End Results (SEER) database. We employed competing risk analyses, propensity score matching (PSM), and Kaplan-Meier survival analyses. The relationship between marital status and GBC was then verified, and the predicted nomogram was constructed., Results: A total of 3913 GBC patients were obtained from the SEER database, and an additional 76 GBC patients from Hangzhou Traditional Chinese Medicine Hospital were selected as the external validation group. The competing risk analysis revealed a significant disparity in the 5-year cumulative incidence of cancer-specific death (CSD) between the two cohorts (59.1% vs. 65.2%, p = 0.003). Furthermore, the multivariate competing hazards regression analysis identified a significant association (HR, 1.17; 95% CI, 1.04-1.31; p = 0.007) between marital status and CSD. To assess the 1-, 3-, and 5-year risks of CSD, a comprehensive competing event nomogram was constructed using factors derived from the multivariate analysis. The area under the receiver operating characteristic curve (AUC) values for the 1-, 3-, and 5-year training cohorts were 0.806, 0.785, and 0.776, respectively. In the internal validation cohort, these values were 0.798, 0.790, and 0.790, while the external validation cohort exhibited AUC values of 0.748, 0.835, and 0.883 for the corresponding time intervals. Furthermore, calibration curves demonstrated a commendable level of concordance between the observed and predicted probabilities of CSD., Conclusion: Marriage was a protective factor for GBC patients after taking competing risk into consideration. The proposed nomogram demonstrated exceptional predictive power., (© 2024. The Author(s).)

Our study aims to explore the relationship between chronic hepatitis B virus (HBV) infection and the risk of gastrointestinal (GI) cancers including liver, gastric, gallbladder or extrahepatic bile duct, pancreatic, small intestine, esophageal and colorectal cancer in the Kailuan Cohort study. We prospectively examined the relationship between HBV infection and new‐onset GI cancers among 93 402 participants. Cox proportional hazards regression models, subgroup analyses and competing risk analyses were used to evaluate the association between HBV infection and the risk of new‐onset GI cancers. During a median follow‐up of 13.02 years, 1791 incident GI cancer cases were diagnosed. Compared to HBsAg seronegative participants, a significant positive association between HBV infection and GI cancers was observed in the multivariate‐adjusted models (HR 5.59, 95% CI: 4.84‐6.45). In the site‐specific analyses, participants with HBsAg seropositive exhibited an increased risk of liver cancer (HR = 21.56, 95% CI: 17.32‐26.85), gallbladder or extrahepatic bile duct cancer (HR = 14.89, 95% CI: 10.36‐21.41), colorectal cancer (HR = 1.75, 95% CI: 1.15‐2.96) and pancreatic cancer (HR = 1.86, 95% CI: 1.10‐3.99). After taking death as the competing risk event, the associations of HBV infection with the risk of these cancers were attenuated but remained significant both in the cause‐specific hazards models, the subdistribution proportional hazards models and sensitivity analyses. Our study suggests that HBV infection is associated with the elevated risk of liver cancer and extrahepatic cancer including gallbladder or extrahepatic bile duct, pancreatic and colorectal cancer among adults in Northern China. [ABSTRACT FROM AUTHOR]

There is a lack of comprehensive analysis of recent gallbladder cancer (GBC) mortality trends in China. This study aims to analyse trends in GBC mortality in China, with a specific focus on urban and rural area differences, and to determine possible risk factors. This was a cross-sectional study. Data were accessed through the Chinese Health Statistics Annual Report for 31 provinces from 2013 to 2019. Age-standardised mortality rate (ASMR) stratified by regions, gender and the years of diagnoses were analysed by Joinpoint regression analysis. The GBC ASMR was higher in females than in males and higher in urban areas than in rural areas. Mortality was primarily observed in individuals aged ≥65 years (in both sexes). A non-significant downward trend of GBC mortality was identified in urban areas from 2013 to 2019 (average annual percent change [AAPC] −1.50%; 95% confidence interval [CI]: −3.49, 0.53). However, in rural areas, the ASMR significantly increased with an AAPC of 2.64% (95% CI: 1.15, 4.15) in males and 3.85% (95% CI: 2.17, 5.56) in females. The GBC mortality rate was positively related to red meat consumption. The burden of GBC mortality in rural China cannot be ignored, as results from this study show significantly increasing trends in both females and males from 2013 to 2019. In addition, red meat consumption may play a vital role in the increasing GBC mortality rate. [ABSTRACT FROM AUTHOR]

HER2 amplification/overexpression is a common driver in a variety of cancers including gallbladder cancer (GBC). For patients with metastatic GBC, chemotherapy remains the standard of care with limited efficacy. The combination of HER2 antibody trastuzumab plus chemotherapy is the frontline treatment option for patients with HER2-positive breast cancer and gastric cancer. Recently, this regime also showed antitumor activity in HER2-positive GBC. However, resistance to this regime represents a clinical challenge. Camrelizumab is a novel PD-1 antibody approved for Hodgkin lymphoma and hepatocellular carcinoma in China. In this study, we presented a HER2-positive metastatic GBC patient who was refractory to trastuzumab plus chemotherapy but experienced significant clinical benefit after the addition of camrelizumab. Our case highlights the potential of immunotherapy in combination with HER2-targeted therapy in HER2-positive GBC. We also demonstrated that two immune-related adverse events (irAEs) associated with camrelizumab can be managed with an anti-VEGF agent apatinib. This case not only highlights the importance of irAE management in patients treated with camrelizumab, but also demonstrates the potential of PD-1 antibody plus trastuzumab in HER2-positive GBC patients who have developed resistance to chemotherapy and trastuzumab-based targeted therapy. [ABSTRACT FROM AUTHOR]

Curative resection stands as the sole potential cure for gallbladder cancer (GBC); nevertheless, a dearth of knowledge persists regarding long-term follow-up data and prognostic factors that hinder achieving a cure post-surgery. A retrospective cohort study was conducted by analyzing pathologically confirmed initial resections for GBC between 2000 and 2013 across three Chinese medical centers. The concept of observed cure refers to a 10-year survival period devoid of any disease recurrence. Employing a semiparametric proportional hazards mixture cure model enabled the identification of clinicopathological factors impeding a cure for GBC post-surgery. In our current study, a total of 331 patients were included, with a follow-up period exceeding a decade. The median overall survival (OS) was recorded at 31.6 months, with 39 patients (11.78%) achieving a 10-year OS, classified as 10-year survivors. Within this subset, 36 patients reached a 10-year relapse-free survival, denoting cure, and yielding an observed cure rate of 10.88%. Notably, factors such as combined surgical resection involving invaded organs, positive lymph node metastasis, and R1 resection (below 1%) were identified as virtually precluding a cure. Additionally, patients with T3-4 stage, hepatic invasion, advanced AJCC stage or poor tumor differentiation exhibited a low likelihood of achieving cure (below 5%). The discovery of these prognostic factors holds significant value in tailoring individualized treatment strategies and enhancing clinical decision-making processes.

Biliary tract cancer (BTC) is a highly malignant tumor with limited treatment options and poor prognosis. Our study aimed to evaluate camrelizumab plus oxaliplatin‐based chemotherapy as first‐line therapy for advanced BTC. In this multicenter, open‐label, phase 2 trial conducted in China (ClinicalTrials.gov, NCT03092895), untreated patients with advanced BTC were given camrelizumab (3 mg/kg iv drip injection, every 2 weeks) plus typical FOLFOX4 (Cam‐FOLFOX4 group; infusional 5‐fluorouracil, leucovorin and oxaliplatin) or GEMOX (Cam‐GEMOX group; infusional gemcitabine and oxaliplatin). The primary endpoint was objective response rate (ORR). Ninety‐two patients were enrolled: 29 received Cam‐FOLFOX4 and 63 received Cam‐GEMOX. The confirmed ORR and disease control rate were 16.3% (95% confidence interval [CI] = 9.4‐25.5) and 75.0% (95% CI = 64.9‐83.4), respectively. Median duration of response was 8.7 months (95% CI = 5.1‐not reached). Median progression‐free survival and overall survival were 5.3 months (95% CI = 3.7‐5.7) and 12.4 months (95% CI = 8.9‐16.1), respectively. Grade ≥3 treatment‐related adverse events (TRAEs) occurred in 82.8% of patients receiving Cam‐FOLFOX4 and in 68.3% receiving Cam‐GEMOX, with no unexpected effects observed. Six (6.5%) patients discontinued treatment due to TRAE. Camrelizumab plus FOLFOX4 or GEMOX as first‐line treatment was effective and tolerable for Chinese patients with advanced BTC, warranting phase 3 trials. What's new? Biliary tract cancer is a highly malignant tumour with limited treatment options and poor prognosis. In this prospective clinical trial in Chinese patients with the intra‐hepatic cholangiocarcinoma subtype predominantly, the authors evaluated the novel PD‐1 inhibitor camrelizumab plus oxaliplatin‐based chemotherapy as first‐line treatment for advanced biliary tract cancer. Preliminary efficacy results were encouraging, with an objective response rate of 16.3%, disease control rate of 75.0%, median progression‐free survival of 5.3 months, and overall survival of 12.4 months, despite the poor baseline status of the patients. Adverse events were manageable. The combined treatment was effective and tolerable, warranting phase 3 trials. [ABSTRACT FROM AUTHOR]

Background: Several clinical studies of vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) therapy as a second‐line treatment for biliary tract cancer (BTC) have shown modest efficacy. In this study, surufatinib was evaluated as a second‐line VEGFR therapy in patients with BTC. Methods: This was a single‐arm, multicenter, open‐label phase 2 study conducted in China. The study enrolled eligible patients with BTC, who had received surufatinib monotherapy as second‐line treatment, at a dose of 300 mg, once daily, in 28‐day cycles. Tumor assessments were performed every 8 weeks (±7 days) according to the Response Evaluation Criteria in Solid Tumors version 1.1. Results: As of November 30, 2018, 39 patients with BTC, including 29 (74.4%) with intrahepatic cholangiocarcinoma, 5 (12.8%) with extrahepatic cholangiocarcinoma, and 5 (12.8%) with gallbladder cancer, were enrolled and treated with surufatinib. The 16‐week progression‐free survival rate was 46.33% (95% CI, 24.38‐65.73), with median progression‐free survival of 3.7 months and median overall survival of 6.9 months. In addition, results from subgroup and post hoc analyses revealed that patients with the proper tumor locations or appropriate levels of serum biomarkers might receive greater clinical benefits. The top 3 treatment‐related adverse events with severity of grade ≥3 included blood bilirubin increased (20.5%), hypertension (17.9%), and proteinuria (12.8%). Conclusions: When applied in the treatment of patients with BTC, surufatinib monotherapy has offered moderate clinical efficacy and shown expected tolerability and safety profiles. When applied in the treatment of biliary tract cancer patients, surufatinib monotherapy has offered moderate clinical efficacy and has shown expected tolerability and safety profiles. [ABSTRACT FROM AUTHOR]

Objective: There is limited prospective evidence on the association of physical activity with hepatobiliary cancer subtypes and other major hepatobiliary diseases, especially in China. We aimed to quantify the associations with risk of these diseases.Methods: The study population involved 460 937 participants of the prospective China Kadoorie Biobank aged 30-79 years from 10 diverse areas in China without history of cancer or hepatobiliary disease at baseline. Cox regression was used to estimate adjusted hazard ratios (HRs) for each disease associated with self-reported total and domain-specific physical activity (occupational and non-occupational, ie, leisure time, household and commuting).Results: During ~10 years of follow-up, 22 012 incident cases of hepatobiliary diseases were recorded. The overall mean (SD) total physical activity was 21.2 (13.9) metabolic equivalent of task (MET)-hours/day, with 62% from occupational activity. Total physical activity was inversely associated with hospitalised non-alcoholic fatty liver disease (HR comparing top vs bottom quintile: 0.62, 95% confidence interval (CI) 0.53 to 0.72), viral hepatitis (0.73, 95% CI 0.62 to 0.87), cirrhosis (0.76, 95% CI 0.66 to 0.88) and liver cancer (0.81, 95% CI 0.71 to 0.93), as well as gallstone disease (0.86, 95% CI 0.81 to 0.90), gallbladder cancer (0.51, 95% CI 0.32 to 0.80) and biliary tract cancer (0.55, 95% CI 0.38 to 0.78). The associations for occupational physical activity were similar to those for total physical activity, but for non-occupational physical activity they differed by disease subtype. For leisure-time physical activity, there was an inverse association with liver cancer and an inverse trend for gallstone disease (HR comparing ≥7.5 MET-hours/day with none: 0.83, 95% CI 0.75 to 0.91 and 0.82, 95% CI 0.66 to 1.01).Conclusion: Among Chinese adults, high total physical activity, particularly occupational physical activity, was inversely associated with risk of major hepatobiliary cancers and diseases, including non-alcoholic fatty liver disease, cirrhosis and certain types of cancer. [ABSTRACT FROM AUTHOR]

Alcohol drinking is associated with increased risks of several site‐specific cancers, but its role in many other cancers remains inconclusive. Evidence is more limited from China, where cancer rates, drinking patterns and alcohol tolerability differ importantly from Western populations. The prospective China Kadoorie Biobank recruited >512 000 adults aged 30 to 79 years from 10 diverse areas during 2004 to 2008, recording alcohol consumption patterns by a standardised questionnaire. Self‐reported alcohol consumption was estimated as grams of pure alcohol per week based on beverage type, amount consumed per occasion and drinking frequency. After 10 years of follow‐up, 26 961 individuals developed cancer. Cox regression was used to estimate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) relating alcohol consumption to incidence of site‐specific cancers. Overall, 33% (n = 69 734) of men drank alcohol regularly (ie, ≥weekly) at baseline. Among male current regular drinkers, alcohol intake showed positive dose‐response associations with risks of cancers in the oesophagus (655 events; HR = 1.98 [95%CI 1.79‐2.18], per 280 g/wk), mouth and throat (236; 1.74 [1.48‐2.05]), liver (573; 1.52 [1.31‐1.76]), colon‐rectum (575; 1.19 [1.00‐1.43]), gallbladder (107; 1.60 [1.16‐2.22]) and lung (1017; 1.25 [1.10‐1.42]), similarly among never‐ and ever‐regular smokers. After adjustment for total alcohol intake, there were greater risks of oesophageal cancer in daily drinkers than nondaily drinkers and of liver cancer when drinking without meals. The risks of oesophageal cancer and lung cancer were greater in men reporting flushing after drinking than not. In this male population, alcohol drinking accounted for 7% of cancer cases. Among women, only 2% drank regularly, with no clear associations between alcohol consumption and cancer risk. Among Chinese men, alcohol drinking is associated with increased risks of cancer at multiple sites, with certain drinking patterns (eg, daily, drinking without meals) and low alcohol tolerance further exacerbating the risks. What's new? A comprehensive assessment of the role of alcohol in cancer aetiology is needed in China, where cancer rates, drinking patterns, and alcohol tolerability differ from those in the West. In this large prospective study, regular alcohol drinkers had increased risks of cancers in several sites previously considered to be alcohol‐related (i.e., oesophagus, mouth and throat, liver and colon‐rectum) as well as in the lung and gallbladder. Certain drinking patterns (e.g., drinking daily or without meals) and low alcohol tolerance further exacerbated the risks. The findings suggest that lowering population‐levels of alcohol consumption is an important strategy for cancer prevention. [ABSTRACT FROM AUTHOR]

Background: The incidence of gallbladder carcinoma (GBM) in China has increased in recent years. Here, the functional mechanism of lncRNA TTN-AS1 in GBC was preliminary elucidated. Methods: The expression levels of lncRNA TTN-AS1, miR-107, and HMGA1 in tissues and cell lines were assessed by RT-qPCR. Cell proliferation was measured by MTT assays. Cell invasion and migration abilities were evaluated by Transwell assays. The relationship between miR-107 and lncRNA TTN-AS1 or HMGA1 was confirmed by luciferase reporter assay. Results: Upregulation of lncRNA TTN-AS1 and downregulation of miR-107 were detected in GBC. Furthermore, the expressions between TTN-AS1 and miR-107 were mutually inhibited in GBC. Functionally, lncRNA TTN-AS1 promoted cell viability and motility in GBC by sponging miR-107. In addition, miR-107 directly targets HMGA1. And HMGA1 can be positively regulated by lncRNA TTN-AS1 in GBC. Furthermore, HMGA1 promoted GBC progression by interacting with lncRNA TTN-AS1/miR-107 axis. Conclusion: LncRNA TTN-AS1 acted as a tumor promoter in GBC by sponging miR-107 and upregulating HMGA1. [ABSTRACT FROM AUTHOR]

Background: Ascariasis is one of the common intestinal infections in developing countries, including China. Migration of Ascaris lumbricoides into the gallbladder is rare, unlike ascariasis of the bile duct and when it does occur, treatment is generally by endoscopic or surgical extraction.Case Presentation: A 4-year-old Uyghur boy with a history of ascariasis developed intermittent upper abdominal pain for 7 days, was being treated by a local practitioner, and when the pain worsened with yellow sclera for 3 days, he was admitted to our hospital. On physical examination, found out the patient with yellowish skin tone, pale yellow fur on tongue, mild yellow staining of the sclera and tenderness in epigastrium. Laboratory data plus liver function test showed damage of liver function. Abdominal Ultrasonography (USG) and Magnetic resonance cholangiopancreatography (MRCP) showed a long, linear, echogenic structure in the gallbladder neck near to the common bile duct. Once the ascariasis diagnosis was established, he was given conservative treatment of magnesium sulfate with herbal medicine. In 4 days, the patient discharged Ascaris through the stool.Conclusions: Conservative treatment of magnesium sulfate with Uyghur medicine treatment according to syndrome differentiation is proven to have curative effect. [ABSTRACT FROM AUTHOR]

We evaluated whether aflatoxin B 1 (AFB 1 ) exposure was associated with later risk of developing gallbladder cancer (GBC). We measured AFB 1 -lysine albumin adducts in baseline samples from the Shanghai Cohort Study of 18 244 men aged 45 to 64 years (recruited 1986-1989). We included 84 GBC cases with sufficient serum and 168 controls matched on age at sample collection, date of blood draw and residence. We calculated adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs) for detectable vs non-detectable AFB 1 -lysine albumin adducts and gallbladder cancer. AFB 1 -lysine albumin adducts were detected in 50.0% of GBC cases, and risk of GBC was twice as high in those with detectable vs undetectable levels (OR = 2.0, 95% CI = 1.0-3.9). ORs ranged from 1.8 (95% CI = 0.75-4.3) for 0.5 to <1.75 pg/mg vs undetectable adduct levels to 2.2 (95% CI = 0.91-5.6) for >3.36 pg/mg vs undetectable, suggesting a dose-response (P trend  = .05). When restricted to cases diagnosed before the median time to diagnosis after blood draw (18.4 years), results were similar (OR = 2.2, 95% CI = 0.80-5.8) to those for the entire follow-up duration. The OR was 9.4 (95% CI = 1.7-51.1) for individuals with detectable AFB 1 -lysine albumin adducts and self-reported gallstones compared to individuals with neither. Participants with detectable AFB 1 -lysine albumin adducts at baseline had increased risk of developing GBC, replicating the previously observed association between AFB 1 exposure and providing the first evidence of temporality., (© 2023 UICC. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Purpose The systemic inflammation response index (SIRI) has been reported to have prognostic ability in various solid tumors but has not been studied in gallbladder cancer (GBC). We aimed to determine its prognostic value in GBC. Materials and Methods From 2003 to 2017, patients with confirmed GBC were recruited. To determine the SIRI's optimal cutoff value, a time-dependent receiver operating characteristic curve was applied. Univariate and multivariate Cox analyses were performed for the recognition of significant factors. Then the cohort was randomly divided into the training and the validation set. A nomogram was constructed using the SIRI and other selected indicators in the training set, and compared with the TNM staging system. C-index, calibration plots, and decision curve analysis were performed to assess the nomogram's clinical utility. Results One hundred twenty-four patients were included. The SIRI's optimal cutoff value divided patients into high (≥ 0.89) and low SIRI (< 0.89) groups. Kaplan-Meier curves according to SIRI levels were significantly different (p < 0.001). The high SIRI group tended to stay longer in hospital and lost more blood during surgery. SIRI, body mass index, weight loss, carbohydrate antigen 19-9, radical surgery, and TNM stage were combined to generate a nomogram (C-index, 0.821 in the training cohort, 0.828 in the validation cohort) that was significantly superior to the TNM staging system both in the training (C-index, 0.655) and validation cohort (C-index, 0.649). Conclusion The SIRI is an independent predictor of prognosis in GBC. A nomogram based on the SIRI may help physicians to precisely stratify patients and implement individualized treatment. [ABSTRACT FROM AUTHOR]

[Display omitted] • A nationwide spatial analysis on surface water pollutants and cancers integrating datasets was conducted. • Geographically weighted random forest addressed spatial heterogeneity for surface water pollutants. • Multiple pollutants of surface water spatially associated with digestive cancer incidence in China. Surface water pollution and digestive cancers are concerning environmental health issues. Multiple pollutants of surface water coexist within unique geospatial heterogeneous contexts of surface water flow, which can lead to complex patterns of impact on cancer incidence. This complexity has posed challenges to comprehensive assessment. In this study, we integrated nationwide surface water data of 21 pollutants collected from 3632 sections of nine large river basins and cancer incidence data for six digestive cancers covering 381.6 million people in China. Local Moran's I method was used to assess the patterns of spatial aggregation of each surface water pollutant separately to observe the local spatial nonstationarity and heterogeneity of the pollutant concentrations in different spatial areas. A geographically weighted random forest (GWRF) model, a spatial machine learning approach, was applied to address the spatial heterogeneity of the pollutants and assess their association with cancer incidence. Goodness-of-fit and overall performance of the GWRF model were assessed by the local statistics in the out-of-bag set, such as the mean local pseudo-R2, increase in mean squared error, and local residuals in each local model. Compared with the aspatial random forest model, the GWRF model had better performance (mean local pseudo-R2 ranged from 0.16 (gallbladder cancer) to 0.60 (pancreatic cancer)). Surface water pollution was associated with digestive cancer incidence mainly in the Songhua and Liaohe, Haihe, and Huaihe River Basins. By focusing on these areas, we identified key pollutants specific to different cancer types. Incidence of oesophageal, stomach, colorectal, gallbladder, and pancreatic cancer was associated with common pollutants such as fluoride and arsenic. Our assessment provides targets for the government and environmental health specialists to take tailored actions to control pollution and effectively prevent cancer incidence. [ABSTRACT FROM AUTHOR]

Immunotherapy and antiangiogenic therapy have shown promising clinical activity in patients with advanced biliary tract cancer (BTC) in clinical trials. As the combination of these two treatments for BTC is not well studied in the real world, the present study retrospectively analyzed the clinical outcomes of patients with unresectable BTC who received immunotherapy-antiangiogenesis combination therapy in a real-world setting. A three-center, retrospective study was performed on patients with unresectable BTC who received a combination of programmed death 1 inhibitor and antiangiogenic agent between March 26, 2019 and November 1, 2021 in China. In total, 68 patients were enrolled in the cohort. The objective response rate and disease control rate were 13.2 and 75.0%, respectively. The median time to progression, progression-free survival and overall survival were 8.2, 5.5 and 10.7 months, respectively. Adverse events of all grades occurred in 58 patients (85.3%). In conclusion, the present study demonstrated that immunotherapy-antiangiogenesis combination therapy may be considered a therapeutic option for patients with unresectable BTC. Further prospective investigations are needed. [ABSTRACT FROM AUTHOR]

Background: Gallbladder cancer is the sixth most common malignant gastrointestinal tumor. Radical surgery is currently the only effective treatment, but patient prognosis is poor, with a 5-year survival rate of only 5-10%. Establishing an effective survival prediction model for gallbladder cancer patients is crucial for disease status assessment, early intervention, and individualized treatment approaches. The existing gallbladder cancer survival prediction model uses clinical data-radiotherapy and chemotherapy, pathology, and surgical scope-but fails to utilize laboratory examination and imaging data, limiting its prediction accuracy and preventing sufficient treatment plan guidance., Aims: The aim of this work is to propose an accurate survival prediction model, based on the deep learning 3D-DenseNet network, integrated with multimodal medical data (enhanced CT imaging, laboratory test results, and data regarding systemic treatments)., Methods: Data were collected from 195 gallbladder cancer patients at two large tertiary hospitals in Shanghai. The 3D-DenseNet network extracted deep imaging features and constructed prognostic factors, from which a multimodal survival prediction model was established, based on the Cox regression model and incorporating patients' laboratory test and systemic treatment data., Results: The model had a C-index of 0.787 in predicting patients' survival rate. Moreover, the area under the curve (AUC) of predicting patients' 1-, 3-, and 5-year survival rates reached 0.827, 0.865, and 0.926, respectively., Conclusions: Compared with the monomodal model based on deep imaging features and the tumor-node-metastasis (TNM) staging system-widely used in clinical practice-our model's prediction accuracy was greatly improved, aiding the prognostic assessment of gallbladder cancer patients., (© 2022. The Author(s).)

Background: Gallbladder cancer is associated with late diagnosis and poor prognosis. Current study aims to develop a prognostic nomogram for predicting survival of gallbladder cancer patients after surgery., Methods: Two large cohorts were included in this analysis. One consisted of 1753 gallbladder cancer patients from the Surveillance, Epidemiology, and End Results (SEER) database, and the other consisted of 239 patients from Shanghai Renji hospital. Significant prognostic factors were identified and integrated to develop the nomogram. Then the model was subjected to bootstrap internal validation and external validation., Results: Univariate and multivariate analysis indicated that age, tumor histology, T-stage, N-stage and M-stage were significant prognostic factors, which were all included to build the nomogram. The model showed good discrimination, with a concordance index (C-index) of 0.724 (95% CI, 0.708-0.740), and good calibration. Application of the nomogram in the validation cohort still presented good discrimination (C-index, 0.715 [95% CI 0.672-0.758]) and good calibration. In the primary cohort, the C-index of the nomogram was 0.724, which was significantly higher than the Nevin staging system (C-index = 0.671; P < 0.001) and the 8th TNM staging system (C-index = 0.682; P < 0.001). In the validation cohort, the C-index of the nomogram was 0.715, which was also higher than the Nevin staging system (C-index = 0.692; P < 0.05) and the 8th TNM staging system (C-index = 0.688; P = 0.06)., Conclusions: The proposed nomogram resulted in more-accurate prognostic prediction for patients with gallbladder cancer after surgery., (© 2022. The Author(s).)

Background: Serum lipids, diabetes, and obesity, individual components of metabolic syndrome, are associated with biliary tract cancer and stone risk, but the associations of metabolic syndrome or insulin resistance with biliary tract cancers and stones are not well studied.Methods: In this population-based case-control study in Shanghai, China (627 biliary tract cancers, 1037 biliary stones, and 959 controls), metabolic syndrome was defined as the presence of any three of the five components, including high waist circumference, high triglycerides, low high-density lipoprotein cholesterol (HDL), high blood pressure, and diabetes. Insulin resistance and β-cell function were assessed, using homeostasis assessment models.Results: Metabolic syndrome was significantly associated with gallbladder cancer (odds ratio (OR)=2.75, 95% confidence interval (95% CI)=1.82-4.15) and biliary stones (OR=1.64, 95% CI=1.24-2.16), with a significant dose effect with increasing number of metabolic syndrome components (P trend <0.0001). The observed association persisted among subjects without a history of diabetes. The association between insulin resistance and gallbladder cancer was borderline (P trend=0.06). There was a significant inverse association between β-cell function and gallbladder cancer risk (P trend <0.001).Conclusion: Our findings suggest that metabolic syndrome and insulin resistance have a role in the aetiology of biliary tract cancers and biliary stones, and if confirmed, they imply that lifestyle control of these factors may lower the risk of biliary stones and biliary tract cancer. [ABSTRACT FROM AUTHOR]

Genetic variations in the gene XPC may be associated with increased risk for gallbladder cancer (GBC). In this study, we detected two non-synonymous polymorphisms in XPC (Ala499Val and Lys939Gln) in 334 cases of GBC and 329 subjects of hospital-based age- and sex frequency-matched controls in China using a polymerase chain reaction–restriction fragment length polymorphism assay. Allelic association analysis for the two single-nucleotide polymorphisms (SNPs) showed that the risk allele T of Ala499Val was significantly associated with GBC [odds ratio (OR) = 1.40, 95% confidence interval (CI): 1.11–1.76, P = 0.005), with a population attributive risk of 5.3%. Logistic regression analysis revealed that Ala499Val CT heterozygote (OR = 1.56, 95% CI: 1.13–2.14, P = 0.002) and TT homozygote (OR = 1.93, 95% CI: 1.04–3.55, P = 0.048) had a significantly increased risk compared with CC homozygotes. Genetic analysis suggested that either the SNPs directly exert an effect or the linked functional gene impact of the disease trait likely follows an additive or dominant model. Gene interaction analysis demonstrated that the effects of XPC diplotypes (defined as the number of risk genotypes at the two SNP loci) were highly dependent on gallstone. The data from this case–control study indicated that XPC exonic variants contributed to the risk of GBC in this Chinese population. [ABSTRACT FROM AUTHOR]

Background: Biliary tract cancers are rare but fatal malignancies. Diabetes has been related to biliary stones, but its association with biliary tract cancers is less conclusive.Methods: In a population-based case-control study of 627 cancers, 1037 stones, and 959 controls in Shanghai, China, we examined the association between diabetes and the risks of biliary tract cancer and stones, as well as the effect of potential mediating factors, including serum lipids and biliary stones (for cancer), contributing to the causal pathway from diabetes to biliary diseases.Results: Independent of body mass index (BMI), diabetes was significantly associated with gallbladder cancer and biliary stones ((odds ratio (OR) (95% confidence interval)=2.6 (1.5-4.7) and 2.0 (1.2-3.3), respectively). Biliary stones and low serum levels of high-density lipoprotein (HDL) were significant mediators of the diabetes effect on gallbladder cancer risk, accounting for 60 and 17% of the diabetes effect, respectively. High-density lipoprotein was also a significant mediator of the diabetes effect on biliary stones, accounting for 18% of the diabetes effect.Conclusions: Independent of BMI, diabetes is a risk factor for gallbladder cancer, but its effect is mediated in part by biliary stones and serum HDL levels, suggesting that gallbladder cancer risk may be reduced by controlling diabetes, stones, and HDL levels. [ABSTRACT FROM AUTHOR]

Objective: To investigate the clinical value of extended radical resection for stage pT3 gallbladder cancer (GBC). Methods: The clinical and pathological data of 323 patients with stage pT3 GBC who received regional radical resection or extended radical resection in 7 domestic hepatobiliary centers in China from January 2013 to December 2018 were retrospectively analyzed. The propensity score matching method was used to select 36 cases in each of the regional radical resection group (group A1) and the extended radical resection group (group B1). The surgical indicators and overall survival rates of the two groups were compared, and prognostic factors were analyzed. Results: The number of positive lymph nodes [2(0,3)] and the total number of lymph nodes removed [3(1,4)] in group B1 were both higher than those in group A1 [1(0,1), 4(2,7)] (all P< 0.05). There was no significant difference in other clinical and pathological factors between the two groups (all P> 0.05). The 1, 3, and 5-year survival rates of group A1 were 75%, 44%, and 29%, respectively, which were significantly higher than those of group B1 of 50%, 15%, and 11% (χ(2)=11.311, all P< 0.001). Extensive radical resection ( HR =2.161, 95 %CI : 1.222-3.821), hepatic parenchymal invasion ( HR =2.324, 95 %CI : 1.305-4.139), positive lymph node rate ≥1/3 ( HR =2.927, 95 %CI : 1.641-5.220), and ⅢB/ⅣB staging ( HR =3.325, 95 %CI : 1.750-6.320) are risk factors for the prognosis of GBC patients (all P< 0.05), of which extended radical resection ( HR =1.969, 95 %CI : 1.083-3.581) was an independent risk factor for prognosis ( P< 0.05). When the ratio of positive lymph nodes was<1/3 and the tumor invaded the hepatic parenchyma, the overall survival rate of group B1 was significantly lower than that of group A1 (all P< 0.05). Conclusions: The overall survival rate in patients with stage pT3 GBC whose lymph node positive rate<1/3 and/or hepatic parenchymal invaded cannot be improved by extended radical resection. Extended radical resection is an independent risk factor for patient prognosis.

Purpose: To describe and interpret secular time trends in gallbladder cancer (GBC) incidence, mortality, and diagnostic approach using 37 years of cancer registry data in urban Shanghai., Methods: Data on registration of GBC in urban Shanghai during 1973 and 2009 were collected by the Shanghai Cancer Registry. To describe time trends and to identify specific time points when significant changes occurred, we used joinpoint regression analysis., Results: The age-standardized rates (ASRs) of incidence increased from 1.1/100,000 (1973-1975) to 2.9/100,000 (2006-2009) in men and from 1.7/100,000 (1973-1975) to 3.9/100,000 (2006-2009) in women. ASRs of incidence increased significantly with estimated annual percent changes (EAPCs) of 2.8% in men and 2.5% in women. The mortality trends increased significantly, with EAPCs of 2.8% in men and 2.5% in women. The increasing incidence and mortality rates were primarily observed in men ⩾60 years of age and in women ⩾70 years of age. Notable downward trends in incidence and mortality were identified among women age 60-69 years over the last decade. The percentage of GBC diagnosed by pathology increased steadily over the years while the percentage of GBC diagnosed by imaging, surgery, and biochemistry sharply increased from 1987 onwards., Conclusions: Thirty-seven years of cancer registry data document a tremendous increase in incidence/mortality and a slight decline in incidence/mortality over the last decades for GBC, especially among women, in Shanghai. The development of diagnostic approaches and aging population may play important roles.

Aim: To integrate clinically significant variables related to prognosis after curative resection for gallbladder carcinoma (GBC) into a predictive nomogram., Methods: One hundred and forty-two GBC patients who underwent curative intent surgical resection at Peking Union Medical College Hospital (PUMCH) were included. This retrospective case study was conducted at PUMCH of the Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC) in China from January 1, 2003 to January 1, 2018. The continuous variable carbohydrate antigen 19-9 (CA19-9) was converted into a categorical variable (cCA19-9) based on the normal reference range. Stages 0 to IIIA were merged into one category, while the remaining stages were grouped into another category. Pathological grade X (GX) was treated as a missing value. A multivariate Cox proportional hazards model was used to select variables to construct a nomogram. Discrimination and calibration of the nomogram were performed via the concordance index (C-index) and calibration plots. The performance of the nomogram was estimated using the calibration curve. Receiver operating characteristic (ROC) curve analysis and decision curve analysis (DCA) were performed to evaluate the predictive accuracy and net benefit of the nomogram, respectively., Results: Of these 142 GBC patients, 55 (38.7%) were male, and the median and mean age were 64 and 63.9 years, respectively. Forty-eight (33.8%) patients in this cohort were censored in the survival analysis. The median survival time was 20 months. A series of methods, including the likelihood ratio test and Akaike information criterion (AIC) as well as stepwise, forward, and backward analyses, were used to select the model, and all yielded identical results. Jaundice [hazard ratio (HR) = 2.9; 95% confidence interval (CI): 1.60-5.27], cCA19-9 (HR = 3.2; 95%CI: 1.91-5.39), stage (HR = 1.89; 95%CI: 1.16-3.09), and resection (R) (HR = 2.82; 95%CI: 1.54-5.16) were selected as significant predictors and combined into a survival time predictive nomogram (C-index = 0.803; 95%CI: 0.766-0.839). High prediction accuracy (adjusted C-index = 0.797) was further verified via bootstrap validation. The calibration plot demonstrated good performance of the nomogram. ROC curve analysis revealed a high sensitivity and specificity. A high net benefit was proven by DCA., Conclusion: A nomogram has been constructed to predict the overall survival of GBC patients who underwent radical surgery from a clinical database of GBC at PUMCH., Competing Interests: Conflict-of-interest statement: We declare that the authors have no conflict of interest.

Aim: To investigate the prognostic value of the combination of preoperative plasma fibrinogen and CA199 in patients with gallbladder carcinoma (GBC)., Methods: The clinicopathological data of 154 GBC patients were retrospectively reviewed after surgery. A receiver operating characteristic (ROC) curve was plotted to verify the optimum cut-off values for plasma fibrinogen and CA199. Univariate and multivariate survival analyses were performed to identify the factors associated with GBC prognosis. Based on the HRs calculated via multivariate survival analyses, patients with elevated plasma fibrinogen and CA199 levels were allocated a score of 2.1; those with an elevated plasma fibrinogen level only were allocated a score of 1, those with an elevated CA199 level only were allocated a score of 1.1, and those with neither of these abnormalities were allocated a score of 0., Results: ROC curve analysis showed that the optimum cut-off values for preoperative plasma fibrinogen and CA199 were 3.47 g/L and 25.45 U/mL, respectively. Multivariate analysis indicated that elevated preoperative plasma fibrinogen and CA199 levels were significantly correlated with worse overall survival (OS) (HR = 1.711, 95%CI: 1.114-2.627, P = 0.014, and HR = 1.842, 95%CI: 1.111-3.056, P = 0.018). When we combined these two parameters, the area under the ROC curve increased from 0.735 (for preoperative plasma fibrinogen only) and 0.729 (for preoperative CA199 only) to 0.765. When this combined variable was added to the multivariate analysis, the combination of plasma fibrinogen and CA199 ( P < 0.001), resection margin ( P < 0.001) and TNM stage ( P = 0.010) were independent prognostic factors for GBC., Conclusion: The combination of plasma fibrinogen and CA199 may serve as a more efficient independent prognostic biomarker for postoperative GBC patients than either parameter alone., Competing Interests: Conflict-of-interest statement: We declare that the authors have no conflict of interest.

Aim: To investigate the impact of surgical procedures on prognosis of gallbladder cancer patients classified with the latest tumor-node-metastasis (TNM) staging system., Methods: A retrospective study was performed by reviewing 152 patients with primary gallbladder carcinoma treated at Peking Union Medical College Hospital from January 2003 to June 2013. Postsurgical follow-up was performed by telephone and outpatient visits. Clinical records were reviewed and patients were grouped based on the new edition of TNM staging system (AJCC, seventh edition, 2010). Prognoses were analyzed and compared based on surgical operations including simple cholecystectomy, radical cholecystectomy (or extended radical cholecystectomy), and palliative surgery. Simple cholecystectomy is, by definition, resection of the gallbladder fossa. Radical cholecystectomy involves a wedge resection of the gallbladder fossa with 2 cm non-neoplastic liver tissue; resection of a suprapancreatic segment of the extrahepatic bile duct and extended portal lymph node dissection may also be considered based on the patient's circumstance. Palliative surgery refers to cholecystectomy with biliary drainage. Data analysis was performed with SPSS 19.0 software. Kaplan-Meier survival analysis and Logrank test were used for survival rate comparison. P < 0.05 was considered statistically significant., Results: Patients were grouped based on the new 7(th) edition of TNM staging system, including 8 cases of stage 0, 10 cases of stage I, 25 cases of stage II, 21 cases of stage IIIA, 21 cases of stage IIIB, 24 cases of stage IVA, 43 cases of stage IVB. Simple cholecystectomy was performed on 28 cases, radical cholecystectomy or expanded gallbladder radical resection on 57 cases, and palliative resection on 28 cases. Thirty-nine cases were not operated. Patients with stages 0 and I disease demonstrated no statistical significant difference in survival time between those receiving radical cholecystectomy and simple cholecystectomy (P = 0.826). The prognosis of stage II patients with radical cholecystectomy was better than that of simple cholecystectomy. For stage III patients, radical cholecystectomy was significantly superior to other surgical options (P < 0.05). For stage IVA patients, radical cholecystectomy was not better than palliative resection and non-surgical treatment. For stage IVB, patients who underwent palliative resection significantly outlived those with non-surgical treatment (P < 0.01) CONCLUSION: For stages 0 and I patients, simple cholecystectomy is the optimal surgical procedure, while radical cholecystectomy should be actively operated for stages II and III patients.