RESUMO
Objective To investigate the clinical value of lymph node dissection (LND) in the radical resection of intrahepatic cholangiocarcinoma (ICC).Methods The propensity score matching and retrospective cohort study was conducted.The clinicopathological data of 448 patients with ICC who were admitted to 12 medical centers from December 2011 to December 2017 were collected,including 279 in the Eastern Hepatobiliary Surgery Hospital of Navy Medical University,32 in the Mengchao Hepatobiliary Hospital of Fujian Medical University,21 in the First Hospital Affiliated to Army Medical University,20 in the Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College,19 in the West China Hospital of Sichuan University,18 in the Second Hospital Affiliated to Zhejiang University School of Medicine,18 in the Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine,16 in the Beijing Friendship Hospital Affiliated to Capital Medical University,10 in the Xuanwu Hospital Affiliated to Capital Medical University,7 in the Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology,5 in the Beijing Tiantan Hospital Affiliated to Capital Medical University,and 3 in the Affiliated Hospital of North Sichuan Medical College.There were 281 males and 167 females,aged from 22 to 80 years,with a median age of 57 years.Of the 448 patients,143 with routinely intraoperative LND were divided into LND group and 305 without routinely intraoperative LND were divided into control group,respectively.Observation indicators:(1) the propensity score matching conditions and comparison of general data between the two groups after matching;(2) intraoperative and postoperative situations;(3) follow-up;(4) survival analysis.Patients were followed up by outpatient examinafion,telephone interview and email to detect survival of patients and tumor recurrence up to October 31,2018 or death.Follow-up was conducted once every 3 months within postoperative 1-2 years,once every 6 months within postoperative 2-5 years,and once a year after 5 years.The propensity score matching was realized using the nearest neighbor method with 1∶1 ratio.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was analyzed using the t test.Measurement data with skewed distribution were represented as M (range),and comparison between groups was analyzed using the Mann-Whitney U test.Count data were described as absolute numbers,and comparison between groups was analyzed using the chi-square test or Fisher exact probability.Kaplan-Meier method was used to calculate survival rates and draw survival curve,and Log-rank test was used to perform survival analysis.Univariate analysis and multivaraiate analysis were conducted using the Log-rank test and COX regression model,respectively.Results (1) The propensity score matching conditions and comparison of general data between the two groups after matching:286 of 448 patients had successful matching,including 143 in each group.The number of males and females,cases with hepatitis,cases with grade A and B of Child-Pugh classification,cases with distance from margin to tumor < 1 cm and ≥ 1 cm,cases with highly,moderately,and poorly differentiated tumor,cases with anatomical hepatectomy and nonanatomical hepatectomy before propensity score matching were 77,66,33,96,47,70,73,105,38,79,64 in the LND group,and 204,101,121,165,140,207,98,251,54,124,181 in the control group,respectively,showing significant differences in the above indices between the two groups (x2 =7.079,11.885,7.098,14.763,5.184,8.362,P<0.05).After propensity score matching,the above indices were 77,66,33,96,47,70,73,105,38,79,64 in the LND group,and 79,64,29,88,55,71,72,112,31,74,69 in the control group,respectively,showing no significant difference in the above indices between the two groups (x2 =0.056,0.329,2.158,0.014,0.936,1.400,P>0.05).(2) Intraoperative and postoperative situations:the operation time,volume of intraoperative blood loss,cases with intraoperative blood transfusion,cases with postoperative complications,and duration of postoperative hospital stay were 265 minutes (range,160-371 minutes),300 mL (range,200-500 mL),37,46,12 days (range,9-17 days) for the LND group,and 59 minutes (range,46-250 minutes),200 mL (range,100-400 mL),24,25,9 days (range,7-11 days) for the control group,respectively.There was no significant difference in the volume of intraoperative blood loss or cases with intraoperative blood transfusion between the two groups (Z =1.700,x2 =3.520,P > 0.05).There were significant differences in the operation time,cases with postoperative complications,and duration of postoperative hospital stay (Z=6.520,x2=8.260,Z=4.270,P<0.05).(3) Follow-up:143 patients in the LND group was followed up for 18-26 months.The 1-,3-,5-year survival rates were 66.9%,32.8%,25.0%,and the median survival time was 22.0 months (range,18.0-26.0 months).In the control group,143 patients were followed up for 11-32 months.The 1-,3-,5-year survival rates were 71.7%,38.0%,31.0%,and the median survival time was 22.0 months (range,11.0-32.0 months).There was no significant difference in the overall survival between the two groups (x2 =0.466,P>0.05).(4) Survival analysis:results of univariate analysis showed that distance from margin to tumor,tumor diameter,the number of tumors,microvascular tumor thrombus,and lymph node metastasis by pathological examination were related factors for prognosis of patients undergoing radical resection of ICC (x2 =10.662,9.477,16.944,6.520,11.633,P<0.05).Results of multivariate analysis showed that distance from margin to tumor< 1 cm,tumor diameter>5 cm,multiple tumors,microvascular tumor thrombus,positive lymph node metastasis by pathological examination were independent risk factors for prognosis of patients undergoing radical resection of ICC (hazard ratio =0.600,1.571,1.601,1.750,1.723,95% confidence interval:0.430-0.837,1.106-2.232,1.115-2.299,1.083-2.829,1.207-2.460,P<0.05).Conclusion Lymph node metastasis is an independent risk factor affecting the prognosis of ICC patients,and it is necessary to perform LND in radical resection for patients with ICC and lymph node metastasis.
RESUMO
Objective:To predict the efficacy of biliary drainage stenting (BDS) versus primary duct closure (PDC) alone after laparoscopic common bile duct exploration (LCBDE)using Bayesian network Meta analysis.Methods:Databases including PubMed, MedLine, Embase, the Cochrane Library, Web of Science, CNKI, Wanfang were searched for literatures from January.1st 1990 to January. 31st 2020 with the key words of ( "Choledocholithiasis" OR "common bile duct stone" OR "CBDS" OR "extrahepatic bile duct stone" ) AND ( "laparoscopic common bile duct exploration" OR "LCBDE" ) AND ( "primary duct closure" or "PDC" ) AND ( "T-tube drainage" or "TTD" or "T-tube" ) AND ( "biliary drainage stenting or BDS" ) AND ( "clinical trials" ),胆总管结石,腹腔镜胆总管探查, T管引流,一期缝合,胆道内支架引流. The randomized controlled trials (RCTs) about comparison of efficacy among BDS, PDC alone and T-tube drainage after LCBDE were received and included. BDS group included patients who underwent BDS after LCBDE, PDC group included patients who underwent PDC alone after LCBDE, and T-tube drainage group included patients who underwent T-tube drainage after LCBDE. The primary outcomes were the incidence of postoperative overall complications, bile leakage and residual stones. GeMTC software was used for Meta analysis in the Rstudio environment. This study was conducted using the random effects model in Bayesian network. The Markov Chain Monte Carlo was used for direct evaluation and indirect prediction. The Brooks-Gelman-Rubing graphing method, tracing method and density plotting were used to evaluate the model convergence. No closed loop formed between intervention measures, so there was no need to evaluate consistency. The matrix of rank probabilities in terms of the outcomes were also calculated.Results:(1) Document retrieval: a total of 12 available RCTs were enrolled. There were 982 patients, including 190 in the BDS group, 296 in the PDC group, and 496 in the T-tube drainage group. (2) Results of Bayesian network meta analysis. ① The BDS group and PDC group had lower overall complication rate than T-tube drainage group [ odds ratio ( OR)=0.21, 0.48, 95% confidence interval ( CI): 0.06-0.52, 0.24-0.87, P<0.05]. There was no significant difference in the indirectly predicted overall complication rate between the BDS group and PDC group ( OR=0.43, 95% CI: 0.12-1.30, P>0.05). ② The BDS group had lower incidence of postoperative bile leakage than T-tube drainage group ( OR=0.18, 95% CI: 0.02-0.86, P<0.05). There was no significant difference in the incidence of postoperative bile leakage between the PDC group and T-tube drainage group ( OR=0.70, 95% CI: 0.27-1.70, P>0.05). There was no significant difference in the indirectly predicted incidence of postoperative bile leakage between the BDS group and T-tube drainage group ( OR=0.25, 95% CI: 0.03-1.60, P>0.05). ③ T-tube drainage group had no significant difference in the incidence of postoperative residual stones compared with the BDS group and PDC group ( OR=0.58, 1.40, 95% CI: 0.13-2.40, 0.41-5.50, P>0.05). There was no significant difference in the indirectly predicted incidence of postoperative residual stones between the BDS group and PDC group ( OR=0.39, 95% CI: 0.05-2.70, P>0.05). (3) Ranking of the incidence of postoperative complication among the three groups: for the BDS group, PDC group, and T-tube drainage group, the probability of ranking the first in the incidence of overall complication was 0.08%, 0.98%, 98.94%, the probability of ranking the second was 6.57%, 92.38%, 1.05%, and the probability of ranking the third was 93.36%, 6.64%, 0.01%, respectively, showing the ranking list as T-tube drainage group >PDC group >BDS group in the incidence of overall complication. The probability of ranking the first in the incidence of postoperative bile leakage was 1.25%, 18.93%, 79.82% for the BDS group, PDC group, and T-tube drainage group, the probability of ranking the second was 6.11%, 74.01%, 19.88%, and the probability of ranking the third was 92.64%, 7.06%, 0.30%, respectively, showing the ranking list as T-tube drainage group >PDC group >BDS group in the incidence of postoperative bile leakage. The probability of ranking the first in the incidence of postoperative residual stones was 10.89%, 67.37%, 21.74% for the BDS group, PDC group, and T-tube drainage group, the probability of ranking the second was 16.09%, 21.09%, 62.82%, and the probability of ranking the third was 73.02%, 11.55%, 15.44%, respectively, showing the ranking list as PDC group >T-tube drainage group >BDS group in the incidence of postoperative residual stones. Conclusions:For patients with appropriate choledocholithiasis, BDS would be recommended first after LCBDE, which can reduce duct closure related complications. This study was registered at http: //www.crd.york.ac.uk/ero/, with the registration number of CRD42019137344.
RESUMO
Objective@#To investigate the clinical value of lymph node dissection (LND) in the radical resection of intrahepatic cholangiocarcinoma (ICC).@*Methods@#The propensity score matching and retrospective cohort study was conducted. The clinicopathological data of 448 patients with ICC who were admitted to 12 medical centers from December 2011 to December 2017 were collected, including 279 in the Eastern Hepatobiliary Surgery Hospital of Navy Medical University, 32 in the Mengchao Hepatobiliary Hospital of Fujian Medical University, 21 in the First Hospital Affiliated to Army Medical University, 20 in the Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College, 19 in the West China Hospital of Sichuan University, 18 in the Second Hospital Affiliated to Zhejiang University School of Medicine, 18 in the Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 16 in the Beijing Friendship Hospital Affiliated to Capital Medical University, 10 in the Xuanwu Hospital Affiliated to Capital Medical University, 7 in the Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, 5 in the Beijing Tiantan Hospital Affiliated to Capital Medical University, and 3 in the Affiliated Hospital of North Sichuan Medical College. There were 281 males and 167 females, aged from 22 to 80 years, with a median age of 57 years. Of the 448 patients, 143 with routinely intraoperative LND were divided into LND group and 305 without routinely intraoperative LND were divided into control group, respectively. Observation indicators: (1) the propensity score matching conditions and comparison of general data between the two groups after matching; (2) intraoperative and postoperative situations; (3) follow-up; (4) survival analysis. Patients were followed up by outpatient examination, telephone interview and email to detect survival of patients and tumor recurrence up to October 31, 2018 or death. Follow-up was conducted once every 3 months within postoperative 1-2 years, once every 6 months within postoperative 2-5 years, and once a year after 5 years. The propensity score matching was realized using the nearest neighbor method with 1∶1 ratio. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was analyzed using the t test. Measurement data with skewed distribution were represented as M (range), and comparison between groups was analyzed using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was analyzed using the chi-square test or Fisher exact probability. Kaplan-Meier method was used to calculate survival rates and draw survival curve, and Log-rank test was used to perform survival analysis. Univariate analysis and multivaraiate analysis were conducted using the Log-rank test and COX regression model, respectively.@*Results@#(1) The propensity score matching conditions and comparison of general data between the two groups after matching: 286 of 448 patients had successful matching, including 143 in each group. The number of males and females, cases with hepatitis, cases with grade A and B of Child-Pugh classification, cases with distance from margin to tumor <1 cm and ≥1 cm, cases with highly, moderately, and poorly differentiated tumor, cases with anatomical hepatectomy and nonanatomical hepatectomy before propensity score matching were 77, 66, 33, 96, 47, 70, 73, 105, 38, 79, 64 in the LND group, and 204, 101, 121, 165, 140, 207, 98, 251, 54, 124, 181 in the control group, respectively, showing significant differences in the above indices between the two groups (χ2=7.079, 11.885, 7.098, 14.763, 5.184, 8.362, P<0.05). After propensity score matching, the above indices were 77, 66, 33, 96, 47, 70, 73, 105, 38, 79, 64 in the LND group, and 79, 64, 29, 88, 55, 71, 72, 112, 31, 74, 69 in the control group, respectively, showing no significant difference in the above indices between the two groups (χ2=0.056, 0.329, 2.158, 0.014, 0.936, 1.400, P>0.05). (2) Intraoperative and postoperative situations: the operation time, volume of intraoperative blood loss, cases with intraoperative blood transfusion, cases with postoperative complications, and duration of postoperative hospital stay were 265 minutes (range, 160-371 minutes), 300 mL (range, 200-500 mL), 37, 46, 12 days (range, 9-17 days) for the LND group, and 59 minutes (range, 46-250 minutes), 200 mL (range, 100-400 mL), 24, 25, 9 days (range, 7-11 days) for the control group, respectively. There was no significant difference in the volume of intraoperative blood loss or cases with intraoperative blood transfusion between the two groups (Z=1.700, χ2=3.520, P>0.05). There were significant differences in the operation time, cases with postoperative complications, and duration of postoperative hospital stay (Z=6.520, χ2=8.260, Z=4.270, P<0.05). (3) Follow-up: 143 patients in the LND group was followed up for 18-26 months. The 1-, 3-, 5-year survival rates were 66.9%, 32.8%, 25.0%, and the median survival time was 22.0 months (range, 18.0-26.0 months). In the control group, 143 patients were followed up for 11-32 months. The 1-, 3-, 5-year survival rates were 71.7%, 38.0%, 31.0%, and the median survival time was 22.0 months (range, 11.0-32.0 months). There was no significant difference in the overall survival between the two groups (χ2=0.466, P>0.05). (4) Survival analysis: results of univariate analysis showed that distance from margin to tumor, tumor diameter, the number of tumors, microvascular tumor thrombus, and lymph node metastasis by pathological examination were related factors for prognosis of patients undergoing radical resection of ICC (χ2=10.662, 9.477, 16.944, 6.520, 11.633, P<0.05). Results of multivariate analysis showed that distance from margin to tumor<1 cm, tumor diameter>5 cm, multiple tumors, microvascular tumor thrombus, positive lymph node metastasis by pathological examination were independent risk factors for prognosis of patients undergoing radical resection of ICC (hazard ratio=0.600, 1.571, 1.601, 1.750, 1.723, 95% confidence interval: 0.430-0.837, 1.106-2.232, 1.115-2.299, 1.083-2.829, 1.207-2.460, P<0.05).@*Conclusion@#Lymph node metastasis is an independent risk factor affecting the prognosis of ICC patients, and it is necessary to perform LND in radical resection for patients with ICC and lymph node metastasis.