ABSTRACT
Objective To investigate the incidence of postoperative pancreatic fistula (POPF) and its risk factors after radical gastrectomy.Methods The prospective study was conducted.The clinicopathological data of 2 089 patients who underwent radical gastrectomy in 22 medical centers between December 2017 and November 2018 were collected,including 380 in the Zhongshan Hospital of Fudan University,351 in the Renji Hospital of Shanghai Jiaotong University School of Medicine,130 in the Ruijin Hospital of Shanghai Jiaotong University School of Medicine,139 in the Peking University Cancer Hospital,128 in the Fujian Provincial Cancer Hospital,114 in the First Hospital Affiliated to Army Medical University,104 in the First Affiliated Hospital of Nanchang University,104 in the Affiliated Hospital of Qinghai University,103 in the Weifang People's Hospital,102 in the Fujian Medical University Union Hospital,99 in the First Affiliated Hospital of Air Force Medical University,97 in the Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine,60 in the Hangzhou First People's Hospital Affiliated to Zhejiang University School of Medicine,48 in the Fudan University Shanghai Cancer Center,29 in the First Affiliated Hospital of Xi'an Jiaotong University,26 in the Lishui Municipal Central Hospital,26 in the Guangdong Provincial People's Hospital,23 in the Jiangsu Province Hospital,13 in the First Affiliated Hospital of Sun Yat-Sen University,7 in the Second Hospital of Jilin University,4 in the First Affiliated Hospital of Xinjiang Medical University,2 in the Beijing Chao-Yang Hospital of Capital Medical University.Observation indicators:(1) the incidence of POPF after radical gastrectomy;(2) treatment of grade B POPF after radical gastrectomy;(3) analysis of clinicopathological data;(4) analysis of surgical data;(5) risk factors for grade B POPF after radical gastrectomy.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was analyzed using ANOVA.Count data were described as absolute numbers or percentages,and comparison between groups was analyzed using the chi-square test.Univariate analysis was conducted using the t test or chi-square test based on data excluding missing data of clinicopathological and surgical data.Multivariate analysis was conducted using the Logistic regression model based on factors with P＜0.20 in univariate analysis.Results There were 2 089 patients screened for eligibility,including 1 512 males,576 females and 1 without sex information,aged (62± 11)years.The body mass index (BMI) was (23±3) kg/m2.(1) The incidence of POPF after radical gastrectomy:the total incidence rate of POPF in the 2 089 patients was 20.728％(433/2 089).The incidence rates of biochemical fistula,grade B pancreatic fistula,and grade C pancreatic fistula were 19.627％(410/2 089),1.101％(23/2 089),0,respectively.(2) Treatment of grade B POPF after radical gastrectomy:2 of 23 patients with grade B POPF after radical gastrectomy had drainage tube placed for more than 21 days and received anti-infective therapy.Four of 23 patients with grade B POPF after radical gastrectomy had ascites detected by imaging examination,of which 2 received peritoneal drainage guided by ultrasound,1 received failed puncture drainage,1 received no puncture drainage,and they were given anti-infective therapy.Eleven of 23 patients with grade B POPF after radical gastrectomy had no ascites detected by imaging examinations,and they were given anti-infective therapy and inhibitors of pancreas secretion for clinical manifestation as fever or elevated white blood cells.Six patients with no typical clinical manifestations were given somatostatin to inhibite pancreas secretion and prolonged duration of abdominal drainage tube placement (with a median time of 7 days).All the 23 patients recovered well after treatment,without reoperation.(3) Analysis of clinicopathological data:for the 2 089 patients,BMI,cases with or without neoadjuvant therapy were (23±3) kg/m2,1 487,160 of patients without pancreatic fistula,(23±3)kg/m2,386,22 of patients with biochemical fistula,and (24±3)kg/m2,22,1 of patents with grade B pancreatic fistula,showing significant differences between the three groups (F=5.787,x2 =8.269,P＜0.05).(4) Analysis of surgical data:for the 2 089 patients,cases with open surgery,laparoscopic assisted surgery,totally laparoscopic surgery (surgical method),cases with D1 lymph lode dissection,D2 lymph lode dissection,and other lymph lode dissection (range of lymph lode dissection),cases with no omentectomy,partial omentectomy,and total omentectomy (range of omentectomy),cases with no usage of energy facility,usage of CUSA,LigaSure,LigaSure+CUSA as energy facility,cases with or without biological glue,the number of lymph node dissection were 737,624,292,24,1 580,51,418,834,381,63,1 530,23,16,1 431,201,33±14 of patients without pancreatic fistula,146,189,74,11,389,9,110,171,128,35,359,6,9,378,31,31± 14 of patients with biochemical fistula,and 14,5,4,0,20,3,6,13,4,2,18,1,2,22,1,37±16 of patients with grade B pancreatic fistula,showing significant differences between the three groups (x2=15.578,9.397,15.023,28.245,8.359,F=4.945,P＜ 0.05).(5) Risk factors for grade B POPF after radical gastrectomy:results of univariate analysis showed that usage of energy facility was a related factor for grade B POPF after radical gastrectomy (x2=9.914,P＜0.05).Results of multivariate analysis showed that laparoscopic assisted surgery,combined evisceration,application of LigaSure + CUSA,the number of lymph lode dissection were independent factors for for grade B POPF after radical gastrectomy (odds ratio=0.168,3.922,9.250,1.030,95％ confidence interval:0.036-0.789,1.031-14.919,1.036-82.602,1.001-1.059,P＜0.05).Conclusions The incidence of grade B POPF after radical gastrectomy is relatively low.Laparoscopic assisted surgery,combined evisceration,application of LigaSure + CUSA,and the number of lymph lode dissection are independent risk factors for grade B POPF.Trial Registration:This study was registrated at ClinicalTrial.gov in United States with the registration number of NCT03391687.
ABSTRACT
Objective@#To investigate the incidence of postoperative pancreatic fistula (POPF) and its risk factors after radical gastrectomy.@*Methods@#The prospective study was conducted. The clinicopathological data of 2 089 patients who underwent radical gastrectomy in 22 medical centers between December 2017 and November 2018 were collected, including 380 in the Zhongshan Hospital of Fudan University, 351 in the Renji Hospital of Shanghai Jiaotong University School of Medicine, 130 in the Ruijin Hospital of Shanghai Jiaotong University School of Medicine, 139 in the Peking University Cancer Hospital, 128 in the Fujian Provincial Cancer Hospital, 114 in the First Hospital Affiliated to Army Medical University, 104 in the First Affiliated Hospital of Nanchang University, 104 in the Affiliated Hospital of Qinghai University, 103 in the Weifang People′s Hospital, 102 in the Fujian Medical University Union Hospital, 99 in the First Affiliated Hospital of Air Force Medical University, 97 in the Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, 60 in the Hangzhou First People′s Hospital Affiliated to Zhejiang University School of Medicine, 48 in the Fudan University Shanghai Cancer Center, 29 in the First Affiliated Hospital of Xi′an Jiaotong University, 26 in the Lishui Municipal Central Hospital, 26 in the Guangdong Provincial People′s Hospital, 23 in the Jiangsu Province Hospital, 13 in the First Affiliated Hospital of Sun Yat-Sen University, 7 in the Second Hospital of Jilin University, 4 in the First Affiliated Hospital of Xinjiang Medical University, 2 in the Beijing Chao-Yang Hospital of Capital Medical University. Observation indicators: (1) the incidence of POPF after radical gastrectomy; (2) treatment of grade B POPF after radical gastrectomy; (3) analysis of clinicopathological data; (4) analysis of surgical data; (5) risk factors for grade B POPF after radical gastrectomy. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was analyzed using ANOVA. Count data were described as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test. Univariate analysis was conducted using the t test or chi-square test based on data excluding missing data of clinico-pathological and surgical data. Multivariate analysis was conducted using the Logistic regression model based on factors with P<0.20 in univariate analysis.@*Results@#There were 2 089 patients screened for eligibility, including 1 512 males, 576 females and 1 without sex information, aged (62±11)years. The body mass index (BMI) was (23±3)kg/m2. (1) The incidence of POPF after radical gastrectomy: the total incidence rate of POPF in the 2 089 patients was 20.728%(433/2 089). The incidence rates of biochemical fistula, grade B pancreatic fistula, and grade C pancreatic fistula were 19.627%(410/2 089), 1.101%(23/2 089), 0, respectively. (2) Treatment of grade B POPF after radical gastrectomy: 2 of 23 patients with grade B POPF after radical gastrectomy had drainage tube placed for more than 21 days and received anti-infective therapy. Four of 23 patients with grade B POPF after radical gastrectomy had ascites detected by imaging examination, of which 2 received peritoneal drainage guided by ultrasound, 1 received failed puncture drainage, 1 received no puncture drainage, and they were given anti-infective therapy. Eleven of 23 patients with grade B POPF after radical gastrectomy had no ascites detected by imaging examinations, and they were given anti-infective therapy and inhibitors of pancreas secretion for clinical manifestation as fever or elevated white blood cells. Six patients with no typical clinical manifestations were given somatostatin to inhibite pancreas secretion and prolonged duration of abdominal drainage tube placement (with a median time of 7 days). All the 23 patients recovered well after treatment, without reoperation. (3) Analysis of clinicopathological data: for the 2 089 patients, BMI, cases with or without neoadjuvant therapy were (23±3)kg/m2, 1 487, 160 of patients without pancreatic fistula, (23±3)kg/m2, 386, 22 of patients with biochemical fistula, and (24±3)kg/m2, 22, 1 of patents with grade B pancreatic fistula, showing significant differences between the three groups (F=5.787, χ2=8.269, P<0.05). (4) Analysis of surgical data: for the 2 089 patients, cases with open surgery, laparoscopic assisted surgery, totally laparoscopic surgery (surgical method), cases with D1 lymph lode dissection, D2 lymph lode dissection, and other lymph lode dissection (range of lymph lode dissection), cases with no omentectomy, partial omentectomy, and total omentectomy (range of omentectomy), cases with no usage of energy facility, usage of CUSA, LigaSure, LigaSure+ CUSA as energy facility, cases with or without biological glue, the number of lymph node dissection were 737, 624, 292, 24, 1 580, 51, 418, 834, 381, 63, 1 530, 23, 16, 1 431, 201, 33±14 of patients without pancreatic fistula, 146, 189, 74, 11, 389, 9, 110, 171, 128, 35, 359, 6, 9, 378, 31, 31±14 of patients with biochemical fistula, and 14, 5, 4, 0, 20, 3, 6, 13, 4, 2, 18, 1, 2, 22, 1, 37±16 of patients with grade B pancreatic fistula, showing significant differences between the three groups (χ2=15.578, 9.397, 15.023, 28.245, 8.359, F=4.945, P<0.05). (5) Risk factors for grade B POPF after radical gastrectomy: results of univariate analysis showed that usage of energy facility was a related factor for grade B POPF after radical gastrectomy (χ2=9.914, P<0.05). Results of multivariate analysis showed that laparoscopic assisted surgery, combined evisceration, application of LigaSure + CUSA, the number of lymph lode dissection were independent factors for for grade B POPF after radical gastrectomy (odds ratio=0.168, 3.922, 9.250, 1.030, 95% confidence interval: 0.036-0.789, 1.031-14.919, 1.036-82.602, 1.001-1.059, P<0.05).@*Conclusions@#The incidence of grade B POPF after radical gastrectomy is relatively low. Laparoscopic assisted surgery, combined evisceration, application of LigaSure + CUSA, and the number of lymph lode dissection are independent risk factors for grade B POPF. Trial Registration: This study was registrated at ClinicalTrial.gov in United States with the registration number of NCT03391687.
ABSTRACT
Tumor deposit (TD) is a common histopathological finding in gastric cancer. With the improved ability of lymphadenectomy and pathological examination, the positive rate and harvested number of TD are also increasing. The role of TD in staging and prognosis prediction for gastric cancer patients is getting more attention. However, due to the lack of standardization and unification, the denomination, definition and diagnostic criteria are still controversial. The previous studies on the definition and diagnostic criteria of TD were reviewed to standardize the items and improve the awareness. TD is an independent prognostic factor in gastric cancer. Each TD should be counted separately as a lymph node in the final pN determination according to TNM staging system of the Union for International Cancer Control (UICC) or American Joint Committee on Cancer(AJCC) or Japanese classification of gastric carcinoma. But this rule is just an experience-based practice, without support from high-level evidence. Several studies have tried to incorporate TD into TNM staging system to improve the accuracy and discriminative ability. With the wide use of the 8th TNM staging system, how to incorporate TD into the new staging system in an easy and reasonable way still needs more investigations.
Subject(s)
Humans , Lymph Node Excision , Lymph Nodes , Pathology , General Surgery , Neoplasm Staging , Methods , Prognosis , Stomach Neoplasms , Diagnosis , Pathology , TherapeuticsABSTRACT
Objective To compare the differences and clinical value of prognostic evaluation between American Joint Committee on Cancer (AJCC) TNM staging system 7th edition and 8th edition for gastric cancer (GC).Methods The retrospective case-control study was conducted.The clinicopathological data of 1 383 GC patients who were admitted to the First People's Hospital of Changzhou between January 2008 and August 2012 were collected.Distal gastrectomy,proximal gastrectomy + pyloroplasty or total gastrectomy were performed according to preoperative evaluation and intraoperative exploration.Observation indicators:(1) surgical and postoperative situations;(2) follow-up and survival situations;(3) T staging comparison between AJCC TNM staging system 7th edition and 8th edition;(4) N staging comparison of AJCC TNM staging system 8th edition;(5) prognostic analysis in N staging of AJCC TNM staging system 8th edition;(6) TNM staging comparison between AJCC TNM staging system 7th edition and 8th edition;(7) prognostic analysis in different TNM staging between AJCC TNM staging system 7th edition and 8th edition.Follow-up using outpatient examination and telephone interview was performed to detect postoperative survival up to October 2017.Measurement data with normal distribution were represented as x ± s.Measurement data with skewed distribution were described as M (range).The survival curve and survival rate were respectively drawn and calculated by the Kaplan-Meier method,and the Log-rank test was used for survival analysis.Results (1) Surgical and postoperative situations:1 383 GC patients underwent successful radical gastrectomy,including 923 with distal gastrectomy,165 with proximal gastrectomy and 295 with total gastrectomy.Of 1 383 patients,115 with postoperative complications were improved by symptomatic treatment,including 87 with surgical complications and 28 with non-surgical complications.Postoperative pathological examinations:total number of intraoperative lymph node dissection and number of lymph node metastasis were 25± 12 and 7±4;577 didn't have lymph node metastasis and 806 had regional lymph node metastasis;308 were in early GC and 1 075 in advanced GC.(2) Follow-up and survival situations:1 383 patients were followed up for 1-117 months,with a median time of 34 months.The 1-,3-and 5-year survival rates of 1 383 patients were respectively 90.5％,71.9％ and 61.1％.(3) T staging comparison between AJCC TNM staging system 7th edition and 8th edition:T staging definition between AJCC TNM staging system 7th edition and 8th edition was identical.T staging of 1 383 patients:308,192,65,628 and 190 were respectively detected in T1,T2,T3,T4a and T4b stagings.(4) N staging comparison between AJCC TNM staging system 7th edition and 8th edition:N staging definition between AJCC TNM staging system 7th edition and 8th edition was identical.N staging of 1 383 patients:577,255,207,230 and 114 were respectively detected in N0,N1,N2,N3a and N3b stagings.N3a and N3b were classified as N3 staging of AJCC TNM staging system 7thedition,but they were classified as independent staging of AJCC TNM staging system 8th edition.(5) Prognostic analysis in N staging of AJCC TNM staging system 8th edition:5-year survival rate of patients in N0,N1,N2,N3a and N3b stagings was respectively 85.6％,76.5％,59.4％,45.2％ and 32.5％ based on AJCC TNM staging system 8th edition,with a statistically significant difference in survival (x2 =394.400,P＜0.05).There was a statistically significant difference between N0 and N 1 stagings (x2 =45.630,P＜0.05),between N 1 and N2 stagings (x2 =19.470,P＜0.05),between N2 and N3a stagings (x2 =7.602,P＜0.05) and between N3a and N3b stagings (x2=13.020,P＜0.05).(6) TNM staging comparison between AJCC TNM staging system 7th edition and 8th edition:TNM staging of 366 patients had changes,including 2 in T1N3b staging,2 in T2N3b staging,18 in T3N3b staging,120 in T4aN2 staging,149 in T4aN3a staging,34 in T4bN0 staging and 41 in T4bN2 staging;364 were detected in staging Ⅲ in 7th edition and 8th edition,and sub-staging of staging Ⅲ had a change;2 in T1N3b of ⅡB staging were redistricted into Ⅲ B staging based on AJCC TNM staging system 8th edition.(7) Prognostic analysis in different TNM staging between AJCC TNM staging system 7th edition and 8th edition:according to 7th edition,cases and 5-year survival rate were respectively 247,89.5％ in Ⅰ A staging and 147,83.7％ in Ⅰ B staging and 77,75.9％ in ⅡA staging and 207,70.5％ in ⅡB staging and 136,61.0％ in ⅢA staging and 236,37.5％ in Ⅲ B staging and 333,35.4％ in Ⅲ C staging,with a statistically significant difference in survival among sub-stagings (x2 =228.800,P＜0.05).There was a statistically significant difference in survival among Ⅰ,Ⅱ and Ⅲ stagings (x2=189.000,P＜0.05) and between ⅢA and ⅢB or ⅢC stagings (x2=22.710,18.010,P＜0.05).There was no statistically significant difference in survival between Ⅰ A and Ⅰ B stagings (x2=0.179,P＞0.05),between Ⅱ A and Ⅱ B stagings (x2 =0.265,P＞0.05),and between Ⅲ B and Ⅲ C stagings (x2 =1.550,P＞0.05).According to 8th edition,cases and 5-year survival rate were respectively 247,89.5％ in Ⅰ A staging and 147,83.7％ in Ⅰ B staging and 77,75.9％ in Ⅱ A staging and 205,70.7％ in Ⅱ B staging and 288,53.8％ in ⅢA staging and 258,37.3％ in ⅢB staging and 161,28.5％ in ⅢC staging,with a statistically significant difference in survival among sub-stagings (x2=234.900,P ＜ 0.05).There was no statistically significant difference in survival between Ⅰ A and Ⅰ B stagings (x2 =0.179,P＞0.05) and between Ⅱ A and ⅡB stagings (x2 =0.564,P＞0.05).There was statistically significant differences in survival between Ⅲ A and Ⅲ B or ⅢC stagings (x2 =29.790,43.060,P＜0.05) and between Ⅲ B and Ⅲ C stagings (x2 =7.494,P＜0.05).Further analysis showed that changes of TNM staging system between 7th edition and 8th edition were in T3N3b,T4aN2,T4aN3a,T4bN0 and T4bN2 stagings,5-year survival rate in above stagings was respectively 16.7％,35.8％,30.2％,47.1％ and 26.8％,with statistically significant differences in survival between T3N3b and T4aN2,T4aN3a,T4bN0 and T4bN2 stagings (x2 =19.590,8.039,12.070,3.853,P＜0.05),between T4aN2 and T4aN3a,T4bN2 stagings (x2 =6.529,3.859,P ＜ 0.05),between T4aN3a and T4bN0 stagings (x2 =10.400,P＜0.05) and between T4bN0 and T4bN2 stagings (x2=4.636,P＜0.05).There was no statistically significant difference in survival between T4aN2 and T4bN0 stagings (x2 =3.607,P＞0.05) and between T4aN3a and T4bN2 stagings (x2 =0.029,P＞0.05).Conclusions Compared with AJCC TNM staging system 7th edition,N3a and N3b stagings are classified as independent staging in AJCC TNM staging system 8th edition,and 8th edition is more accurate in prognostic evaluation of GC patients in stage Ⅲ.