ABSTRACT
The treatment of hepatobiliary malignant tumor is characterized by the coexistence of multiple treatment methods and multiple disciplines. In order to evaluate the clinical efficacy of different treatment measures or multiple treatment combinations, and to promote the standardized development of comprehensive treatment patterns for hepatobiliary malignant tumor, the Hepatobiliary Center of the First Affiliated Hospital of Nanjing Medical University constructs the registry and follow-up database in hepatobiliary tumor patients based on the information-based platform of the hospital, which will help guide clinicians to make scientific decisions and improve the level of clinical diagnosis and treatment. This study describes the framework design, function modules, data acquisition process and quality control of the database of hepatobiliary malignant tumor. Based on the observational bidirectional cohort study design, the previous clinical data can be sorted to match the current database, on the other hand, the clinical data can be prospectively collected including basic information, admission evaluation, surgical information and postoperative situation, comprehensive treatment measures, regular reexaminations and long-term follow-up, etc. The data quality control system can be improved by formulating standardized operation procedures, regularly personnel training and full-process data management plans. This database will provide high-quality real-world data for clinicians, researchers, and guideline experts, and then provide high-level medical evidence for the standardized development of comprehensive treatment patterns of hepatobiliary malignancies.
ABSTRACT
Objective To investigate the clinical efficacy and prognostic factors of radical hepatectomy of hepatocellular carcinoma (HCC).Methods The retrospective case-control study was conducted.The clinicopathological data of 760 HCC patients who were admitted to the First Affiliated Hospital of Nanjing Medical University from August 2003 to June 2015 were collected.Surgical procedures were determined according to the location,number and size of tumors and anatomical relations among vessels.Observation indicators included:(1)intra-and post-operative situations:surgical procedures,operation time,volume of intraoperative blood loss,cases of intraoperative blood transfusion,postoperative complications,duration of postoperative hospital stay and pathological examination;(2) follow-up:1-,3-,5-year overall and tumor-free survival situations;(3) prognostic factors analysis of HCC patients.Follow-up using outpatient examination and telephone interview was performed to detect patients' survival up to January 2016.Measurement data with normal distribution were represented as-x±s.The survival curve and survival rate were respectively drawn and calculated by the Kaplan-Meier method.The univariate analysis and multivariate analysis were done using the COX regression model.Results (1) Intra-and post-operative situations:all the 760 patients underwent successful operations,including 419 undergoing anatomical hepatectomy and 341 undergoing non-anatomical hepatectomy.R0 and R1 resections were respectively applied to 742 and 18 patients.Two patients were combined with portal vein resection and reconstruction and 1 was combined with resection and reconstruction of inferior vena cava.Operation time,volume of intraoperative blood loss and cases of intraoperative blood transfusion were (226± 115) minutes,(714±706) mL and 88,respectively.Fifty-five patients had postoperative complications,including 20 with abdominal effusion or abscess,16 with pleural effusion,9 with recurrent fever,8 with incisional infection,7 with intra-abdominal hemorrhage,6 with liver failure,3 with pyloric or intestinal obstruction and 2 with renal failure (some patients with multiple complications).Of the 55 patients with postoperative complications,7 with hemorrhage underwent reoperation or interventional therapy and other patients underwent conventional symptomatic treatment.Of 55 patients,5 patients died and other 50 patients were improved.Duration of postoperative hospital stay was (14±6) days.There were 457 patients with minimum margin of tumors ≤ 1.0 cm and 303 with minimum margin of tumors ＞ 1.0 cm.(2) Followup:all the 760 patients were followed up for 1-139 months,with a median time of 25 months.The overall and tumor-free median survival times were 59 months and 31 months,respectively.The 1-,3-,5-year overall and tumor-free survival rates were 81.7％,63.4％,47.9％ and 68.7％,44.9％,29.6％,respectively.(3) Prognostic factors analysis of HCC patients:results of univariate analysis showed that clinical symptoms,alpha-fetoprotein (AFP),Barcelona clinic liver cancer staging,surgical procedures,intraoperative blood transfusion,minimum margin of tumors,number and diameter of tumors,tumor capsule,tumor differentiation,vascular cancer embolus,macrovascular invasion and tumor staging of American Joint Committee on Cancer (AJCC) were related factors affecting prognosis of HCC patients after radical hepatectomy [HR =1.39,1.50,1.92,0.65,1.45,1.68,1.96,1.66,2.26,1.50,2.68,3.37,2.00,95％ confidence interval (CI):1.08-1.79,1.16-1.94,1.68-2.20,0.50-0.84,1.04-2.02,1.28-2.20,1.54-2.49,1.42-1.94,1.69-3.02,1.22-1.85,1.99-3.60,2.61-4.36,1.77-2.27,P＜0.05].Results of multivariate analysis showed that AFP,number and diameter of tumors,tumor differentiation and tumor staging of AJCC were independent factors affecting prognosis of HCC patients after radical hepatectomy (HR=1.61,1.62,1.31,1.40,1.78,95％CI:1.14-2.26,1.22-2.14,1.06-1.63,1.10-1.79,1.27-2.51,P ＜ 0.05).Conclusions The anatomical and non-anatomical hepatectomies are safe and feasible for optional HCC patients,with a good long-term outcome.AFP,number and diameter of tumors,tumor differentiation and tumor staging of AJCC are independent factors affecting prognosis of HCC patients after radical hepatectomy.