Comparison of endoscopic ultrasound-guided hepaticogastrostomy and the antegrade technique: study protocol for a prospective, multicentre, randomised controlled trial

Abstract Background: Endoscopic ultrasound-guided biliary drainage (EUS-BD) is used after failed endoscopic retrograde cholangiopancreatography. Based on existing studies, intrahepatic (IH) approaches are suggested to be preferred in patients with a dilated IH bile duct. Both ultrasound-guided hepaticogastrostomy (EUS-HGS) and ultrasound-guided antegrade treatment (EUS-AG) are available IH approaches for patients with an unreachable papilla. However, a direct comparison between these two approaches is lacking. Therefore, we aim to evaluate and compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. Methods: This is a prospective, randomised, controlled, multicentre study. One-hundred forty-eight patients from three hospitals who met the inclusion criteria will be randomly assigned (1:1) to undergo either EUS-HGS or EUS-AG for relief of biliary obstruction. The final study follow-up is scheduled at 1 year postoperatively. The primary endpoint is to compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. The secondary endpoint is the overall survival rate of patients undergoing EUS-HGS and EUS-AG. The chi-square test, Kaplan-Meier methods, the log-rank test, and Cox regression analysis will be used to analyse the data. Discussion: To our knowledge, this is the first study to compare these two EUS-BD approaches directly using a multicentre, randomized, controlled trial design. The clinical economic indexes will also be compared, as they may also affect the patient’s choice. The result may contribute to establishing a strategic guideline for choosing IH EUS-BD approaches. Trial registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR1900020737; registered on 15 January 2019. http://www.chictr.org.cn/showproj.aspx?proj=33672

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Comparison of endoscopic ultrasound-guided hepaticogastrostomy and the antegrade technique in the management of unresectable malignant biliary obstruction: study protocol for a prospective, multicentre, randomised controlled trial

Trials ◽

10.1186/s13063-020-04758-5 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Ye Liao ◽

Marc Giovannini ◽

Ning Zhong ◽

Tingyue Xiao ◽

Shiyun Sheng ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Endoscopic Ultrasound ◽

Biliary Obstruction ◽

Cox Regression ◽

Controlled Trial ◽

Malignant Biliary Obstruction ◽

Complication Rates ◽

Ultrasound Guided ◽

Cox Regression Analysis ◽

Randomised Controlled

Abstract Background Endoscopic ultrasound-guided biliary drainage (EUS-BD) is used after failed endoscopic retrograde cholangiopancreatography. Based on existing studies, intrahepatic (IH) approaches are preferred in patients with dilated IH bile ducts. Both ultrasound-guided hepaticogastrostomy (EUS-HGS) and ultrasound-guided antegrade treatment (EUS-AG) are appropriate for patients with unreachable papillae. Nevertheless, there have been no direct comparisons between these two approaches. Therefore, we aim to evaluate and compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. Methods This is a prospective, randomised, controlled, multicentre study with two parallel groups without masking. One hundred forty-eight patients from three hospitals who met the inclusion criteria will be randomly assigned (1:1) to undergo either EUS-HGS or EUS-AG for relief of malignant biliary obstruction. The final study follow-up is scheduled at 1 year postoperatively. The primary endpoint is efficiency, described by technical and clinical success rates of EUS-HGS and EUS-AG in patients with unreachable papillae. The secondary endpoints include stent patency, overall survival rates, complication rates, length of hospital stays, and hospitalisation expenses. The chi-square test, Kaplan–Meier methods, log-rank test, and Cox regression analysis will be used to analyse the data. Discussion To our knowledge, this is the first study to compare these two EUS-BD approaches directly using a multicentre, randomised, controlled trial design. The clinical economic indexes will also be compared, as they may also affect the patient’s choice. The result may contribute to establishing a strategic guideline for choosing IH EUS-BD approaches. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR1900020737. Registered on 15 January 2019

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Development of predictive prognostic nomogram for NECs of rectum on population-based exploration

Endocrine Connections ◽

10.1530/ec-18-0353 ◽

2018 ◽

Vol 7 (11) ◽

pp. 1178-1185 ◽

Cited By ~ 1

Author(s):

Yang Lv ◽

Ning Pu ◽

Wei-lin Mao ◽

Wen-qi Chen ◽

Huan-yu Wang ◽

...

Keyword(s):

Cox Regression ◽

Population Based ◽

Prognostic Indicators ◽

Rank Test ◽

Chi Square ◽

Related Factors ◽

Ki 67 ◽

Cox Regression Analysis ◽

Kaplan Meier ◽

Chi Square Test

Aim We aim to investigate the clinical characteristics of the rectal NECs and the prognosis-related factors and construct a nomogram for prognosis prediction. Methods The data of 41 patients and 1028 patients with rectal NEC were retrieved respectively from our institution and SEER database. OS or PFS was defined as the major study outcome. Variables were compared by chi-square test and t-test when appropriate. Kaplan–Meier analysis with log-rank test was used for survival analysis and the Cox regression analysis was applied. The nomogram integrating risk factors for predicting OS was constructed by R to achieve superior discriminatory ability. Predictive utility of the nomogram was determined by concordance index (C-index) and calibration curve. Results In the univariate and multivariate analyses, tumor differentiation, N stage, M stage and resection of primary site were identified as independent prognostic indicators. The linear regression relationship was found between the value of Ki-67 index and the duration of OS (P < 0.05). Furthermore, the independent prognostic factors were added to formulate prognostic nomogram. The constructed nomogram showed good performance according to the C-index. Conclusions Contrary to WHO classification guideline, we found that the rectal NEC diseases are heterogeneous and should be divided as different categories according to the pathological differentiation. Besides, the nomogram formulated in this study showed excellent discriminative capability to predict OS for those patients. More advanced predictive model for this disease is required to assist risk stratification via the formulated nomogram.

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The expression of HOXA9 and its prognostic value in cervical cancer

10.21203/rs.3.rs-54158/v1 ◽

2020 ◽

Author(s):

Keqian Zhang ◽

Tianqi Mao ◽

Zhicheng He ◽

Xiaojiao Wu ◽

Yu Peng ◽

...

Keyword(s):

Cervical Cancer ◽

Prognostic Value ◽

Cox Regression ◽

Figo Stage ◽

Rank Test ◽

Chi Square ◽

Cox Regression Analysis ◽

Normal Tissues ◽

Kaplan Meier ◽

Chi Square Test

Abstract Background The HOXA9 gene, belonging to homeobox (HOX) gene family, has been recently reported dys-expressed in several kinds of human cancers. This study aimed to investigate the expression of HOXA9 and its prognostic value in cervical cancer. Methods The HOXA9 mRNA expression was detected with a quantitative real-time polymerase chain reaction (qRT-PCR) assay, and the association of HOXA9 expression with clinical characteristic was analyzed via chi-square test. Kaplan-Meier and cox regression analyses were conducted to estimate the prognostic value of HOXA9 in cervical cancer. Results HOXA9 expression was significantly down-expressed in cervical cancer tissues compared with that in adjacent normal tissues (P < 0.01). And the expression of HOXA9 was significantly associated with TNM stage, pathological grade, FIGO stage and differentiation (All P < 0.05). In addition, Kaplan–Meier analysis indicated that the overall survival of patients with low HOXA9 expression was shorter than those with high HOXA9 expression (log rank test, P = 0.000). Cox regression analysis revealed that HOXA9 had a high prognostic value in cervical cancer. Conclusion HOXA9 is down-regulated and involved in the development of cervical cancer. Moreover, it may be an useful independent prognostic bio-marker for patients with cervical cancer.

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Rab25 Acts as a Promising Novel Bio-Marker in the Prognosis of Patients with Hepatocellular Carcinoma

10.21203/rs.3.rs-43510/v1 ◽

2020 ◽

Author(s):

Zhong Dai ◽

Ke-Qing Yao ◽

Xing-Sheng Hu ◽

Yi-Qun Li ◽

Yu-Tao Liu ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Prognostic Value ◽

Cox Regression ◽

Rank Test ◽

Chi Square ◽

Cox Regression Analysis ◽

Normal Tissues ◽

Kaplan Meier ◽

Chi Square Test ◽

The Relationship

Abstract Background: Rab25 was indicated to be involved in several human tumors. However, the clinical significance of Rab25 in hepatocellular carcinoma (HCC) was still unclear. The purpose of this study was to investigate the expression and prognostic value of Rab25 in HCC.Methods: The relative mRNA expression levels of Rab25 in HCC tissues and adjacent normal tissues were detected by quantitative real-time polymerase chain reaction (qRT-PCR). Chi-square test was used to analyze the relationship between Rab25 expression and clinical characteristics of patients. The prognostic value of Rab25 in HCC was estimated through Kaplan-Meier method and cox regression analysis.Results: Rab25 gene expression level was significantly higher in HCC tissues than that in normal tissues (P<0.001). Importantly, the increased Rab25 expression was closely associated with TNM stage (P=0.024), metastasis (P=0.022) and invasion classification (P=0.039). Moreover, patients with high Rab25 expression tended to have obviously shorter overall survival than those with low expression of Rab25 (log rank test, P<0.001) via Kaplan-Meier analysis. Univariate and multivariate cox regression analyses revealed that Rab25 was an independent prognostic factor of HCC.Conclusions: Rab25 is up-regulated in HCC and contributes to the progression of this tumor. What’s more, Rab25 may be a potential bio-marker for the prognosis of HCC.

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Connection between Gab1 Polymorphisms and cholangiocarcinoma patients prognosis

10.21203/rs.3.rs-50659/v1 ◽

2020 ◽

Author(s):

Ning Wang ◽

Yanni Li ◽

Yanfang Zheng ◽

Huoming Chen ◽

Xiaolong Wen ◽

...

Keyword(s):

Cox Regression ◽

Survival Rates ◽

Prognostic Significance ◽

Positive Lymph Node ◽

Rank Test ◽

Chi Square ◽

Cox Regression Analysis ◽

Normal Tissues ◽

Qrt Pcr ◽

Chi Square Test

Abstract Background We conducted this study to measure the levels of GRB2 associated binding protein 1 (Gab1) mRNA in cholangiocarcinoma (CCA) tissues and the paired normal tissues. And then assess the prognostic significance of Gab1 in CCA patients. Methods Quantitative real-time (qRT-PCR) was adopted to confirm the expression levels of Gab1 mRNA in both CCA tissues and normal controls. The Chi-square test was applied to estimate the influence of clinical parameters on Gab1 expression. Kaplan-Meier survival analysis with log-rank test were used to determine overall survival rates of patients with different Gab1 expression. Cox regression analysis was carried out to evaluate prognostic value of factors in CCA patients. Results According to the qRT-PCR result, increased expression of Gab1 mRNA was found in CCA tissues compared with the paired noncancerous controls (P<0.0001). The Chi-square test demonstrated that the elevated expression of Gab1 was affected by poor differentiation (P=0.022), positive lymph node metastasis (P=0.008) and high TNM stage (P=0.004). However, age, gender, family history and resection margin had no significant influence on Gab1 levels (all, P>0.05). The survival curves suggested that up-regulation of Gab1 was related with poor prognosis of CCA patients. Furthermore, the Cox analysis demonstrated Gab1 was a prognostic biomarker for CCA patients (P=0.000, 95%CI=2.576, HR=1.552-4.275). Conclusion Taken together, Gab1 expression was increased in CCA and may be a useful biomarker to predict the outcomes of CCA patients.

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CIP4 Expression is Associated With The Prognosis in Colorectal Cancer

10.21203/rs.3.rs-95046/v1 ◽

2020 ◽

Author(s):

Keqian Zhang ◽

Tianqi Mao ◽

Zhicheng He ◽

Xiaojiao Wu ◽

Yu Peng ◽

...

Keyword(s):

Colorectal Cancer ◽

Cox Regression ◽

Prognostic Significance ◽

Lymphatic Invasion ◽

Chi Square ◽

Interacting Protein ◽

Cox Regression Analysis ◽

Kaplan Meier ◽

Chi Square Test ◽

Student’S T

Abstract Background: This study was conducted to detect the expression of Cdc42 interacting protein 4 (CIP4) in patients with colorectal cancer (CRC), and explore the role of CIP4 in prognosis of CRC patients.Methods: The expression of CIP4 mRNA was determined by quantitative real-time PCR (qRT-CPR) and compared by student’s t-test between groups. Relationships of clinical characteristics and CIP4 expression were analyzed by Chi-square test. Kaplan-Meier curves were used to estimate the overall survival of CRC patients. And Cox regression analysis was conducted to identify the prognostic biomarkers for CRC patients.Results: The qRT-PCR results showed that CRC tissues were detected with significantly high CIP4 mRNA expression compared with adjacent normal controls (P<0.0001). The overexpression of CIP4 in CRC tissues was influenced by distant metastasis (P=0.021), lymphatic invasion (P=0.012) and TNM stage (P=0.006). But, other clinical factors including age, gender, differentiation and tumor site were proved to have no obvious effects on CIP4 expression (all, P>0.05). The survival curves showed that patients with high CIP4 expression generally lived shorter than those with low CIP4 expression (P<0.001). In addition, the multivariate analysis revealed that differentiation (P=0.044, HR=1.631, 95%CI=1.013-2.626) and CIP4 expression (P=0.000, HR=5.283, 95%CI=3.138-8.893) were of great prognostic significance for CRC patients.Conclusion: Taken together, up-regulation of CIP4 in CRC tissues represented poor prognosis for patients.

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Analysis of Scoring Sequences in Matches of the Portuguese Premier League

Journal of Human Kinetics ◽

10.1515/hukin-2017-0199 ◽

2018 ◽

Vol 64 (1) ◽

pp. 255-263

Author(s):

José M. Pratas ◽

Anna Volossovitch ◽

Ana I. Carita

Keyword(s):

Regression Analysis ◽

Cox Regression ◽

Cox Model ◽

Positive Association ◽

Descriptive Statistics ◽

Chi Square ◽

Cox Regression Analysis ◽

Premier League ◽

Chi Square Test

AbstractThe aim of this study was to examine the sequences of the first two goals scored in soccer matches in accordance with a range of different match contexts. Data from 1506 matches played in the Portuguese Premier League during six consecutive competitive seasons (2009-10 to 2014-2015) were analysed using descriptive statistics and the chi-square test in order to verify the association between variables and a Cox regression analysis was used to predict the time the second goal was scored in function of the time of the first goal scored in the match and the scoreline. The results revealed a higher frequency of the second goals being scored in the second half of a match (58%) and in the last 5 min periods of each half. A positive association was found for home teams and score-doubling goals (58%), as well as for away teams and score-equalizing goals (56%). For home and away teams the score-doubling goal of a match was strongly and positively associated with a win outcome for home (93%) and away teams (92%), while the score-equalizing goals were associated with a draw (home and away teams: 44%) and loss outcome (home: 33% and away teams: 32%). Finally, the Cox model showed that if the first goal was scored in the second half of the match, the probability of the second goal being scored was three times higher compared to the first half.

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Efficacy and toxicity according to hormone therapy used in the CHHiP trial.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.316 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. 316-316 ◽

Cited By ~ 1

Author(s):

Alison Tree ◽

Clare Griffin ◽

Emma Hall ◽

David P. Dearnaley ◽

Keyword(s):

Erectile Function ◽

Cox Regression ◽

Controlled Trial ◽

Similar Efficacy ◽

Trend Test ◽

Chi Square ◽

Patient Reported ◽

Toxicity Analysis ◽

Randomised Controlled

316 Background: CHHiP (CRUK/06/016) is a multicentre randomised controlled trial which investigated the use of moderately hypofractionated radiotherapy (RT) dose schedules for treatment of localised prostate cancer. 97% of participants (pts) had concurrent androgen deprivation therapy (ADT). Luteinising Hormone Releasing Hormone analogues (LHRHa) and bicalutamide 150mg (BIC) daily were permitted. This exploratory analysis investigates whether both ADT regimens show similar efficacy and whether BIC has the propensity to preserve erectile function. Methods: In CHHiP, 2700 pts received LHRH and 403 BIC, median duration 5.6 months. The primary endpoint was biochemical or clinical failure (BCF). ADT groups were compared with Cox regression adjusted forage, NCCN risk group, Gleason score,T-stage and stratified by RT dose. A key secondary endpoint was erectile function assessed by clinicians (LENTSOM subjective erectile function for vaginal penetration score) and pts (single items within UCLA-PCI and EPIC-50 questionnaires) at 2 years. 195/875 (22%) pts were excluded from this toxicity analysis as they had erectile dysfunction pre-ADT (grade (G) 3/4 LENTSOM). A chi square trend test compared ADT regimens. Results: Baseline demographics were similar except BIC pts were significantly younger (median 67 years BIC, 69 years LHRHa). With a median follow-up of 9.2 years, there was no evidence of a difference in BCF with an adjusted hazard ratio 0.95 (95% CI 0.75-1.20), p = 0.657. Eight year BCF rates were 80.7% (95%CI 79.0-82.2) and 80.3% (95%CI 75.8-84.0) for LHRHa and BIC pts respectively. At two years, LENTSOM erectile function was significantly worse (p < 0.0001) for LHRHa pts with 93/585 (16%), 95/585 (16%) and 125/585 (21%) G2, G3 and G4, compared to 3/68 (4%), 5/68 (7%) and 9/68 (13%) in BIC. At 2 years, the ability to have an erection, as reported by pts, was graded poor and very poor in 73/278 (26%) and 57/278 (21%) LHRHa pts and 5/23 (22%) and 4/23 (17%) in BIC pts (p = 0.584). Conclusions: There was no evidence of a difference in efficacy according to ADT received. BIC preserved clinician assessed (LENTSOM) erectile function at 2 years but patient reported outcomes did not show statistically significant differences with type of ADT. Clinical trial information: 97182923.

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MicroRNA-124 alone might represent an indicator signifying cholangiocarcinoma prognosis

10.21203/rs.3.rs-33111/v1 ◽

2020 ◽

Author(s):

Ning Wang ◽

Yanni Li ◽

Yanfang Zheng ◽

Huoming Chen ◽

Xiaolong Wen ◽

...

Keyword(s):

Overall Survival ◽

Cox Regression ◽

Prognostic Biomarker ◽

Prognostic Indicator ◽

Rank Test ◽

Chi Square ◽

Log Rank Test ◽

Kaplan Meier ◽

Chi Square Test ◽

Polymerase Chain

Abstract Background: Previous studies have demonstrated that microRNAs (miRNAs) played a crucial role in various diseases, including cancers. The aim of the study was to evaluate the clinical significance of miR-124 in patients with cholangiocarcinoma (CCA).Methods: The expression pattern of miR-124 was detected in CCA tissues using quantitative reserve transcription polymerase chain reaction (qRT-PCR). The correlation of miR-124 expression with clinicopathological features and overall survival of patients were explored using chi-square test, Kaplan-Meier methods and Cox regression analyses.Results: The miR-124 expression level was strong down-regulated in CCA tissues compared with normal para-cancerous tissues (P<0.001). Moreover, aberrant miR-124 expression was significantly associated with differentiation (P=0.045) and lymph node metastasis (P=0.040). In addition, Kaplan-Meier method and log-rank test revealed that patients with low miR-124 expression has a poorer overall survival compared with those with high miR-124 expression (P=0.002). Furthermore, multivariate analysis confirmed that miR-124 expression (P=0.006; HR=2.006; 95%CI: 1.224-3.289) was an independent prognostic indicator in CCA.Conclusions: Collectively, our results defined miR-124 expression plays important roles in CCA patients. MiR-124 expression might used as a valuable prognostic biomarker for patients with CCA.

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High amphiregulin mRNA expression is a strong prognostic biomarker with response to cetuximab in FIRE-1, CIOX, and FIRE-3.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.4026 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 4026-4026

Author(s):

Arndt Stahler ◽

Sebastian Stintzing ◽

Dominik Paul Modest ◽

Ingrid Ricard ◽

Christine Kapaun ◽

...

Keyword(s):

Mrna Expression ◽

Cox Regression ◽

Prognostic Biomarker ◽

Progression Free Survival ◽

Housekeeping Genes ◽

Threshold Values ◽

Chi Square ◽

Cox Regression Analysis ◽

Chi Square Test ◽

Treatment Table

4026 Background: Amphiregulin ( AREG) and epiregulin ( EREG) were discussed as biomarkers for treatment of metastatic colorectal cancer (mCRC). Data from randomized controlled trials (RCT) are limited. Methods: AREG and EREG mRNA expression by RTqPCR in relation to housekeeping genes were available from 688 patients of three RCT (FIRE-1, n = 192, FUFIRI vs. mIrOx; CIOX, n = 113, cetuximab + CAPIRI/CAPOX; FIRE-3, n = 383, FOLFIRI+cetuximab/bevacizumab) and were normalized to their respective range of each trial with median and 3rd quartile as threshold values. Kaplan-Meier estimated overall survival (OS) and progression-free survival (PFS). Cox regression analysis calculated hazard ratio (HR) and 95% confidence interval (95% CI). Overall response rate (ORR) was compared by chi square test. Results: Across all trials, high AREG mRNA expression appeared as strong prognostic biomarker for OS, PFS and ORR for all threshold values. In RAS wildtype patients, high AREG expression was associated with better OS and PFS for cetuximab but not bevacizumab treatment. (Table) No effects were seen for epiregulin when all trials were analysed together. Conclusions: High AREG mRNA expression appeared as strong prognostic biomarker in mCRC. Positive predictive information might exist for cetuximab treatment. [Table: see text]

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