This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.
Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Objective To study the effectiveness of the complete ureterel reconstruction using bladder flap after cadaveric renal transplantaion.Methods In 13 recipients with complete necrosis of ureter after renal transplant from July 1995 to October 2003, tubelike bladder flaps were applied to ureteraplasty substitute for the necrosis ureter. Artificial pyeloureterostomy was performed and double T tubes were used as the stents. Routine drainage-tubes were placed in incisions. Results All patients were successful in ureteral reconstruction. The renal function of 10 patients was improved significantly 4 weeks postoperation. Nephrectomy was performed in one patient because of severe circumrenal infection 7 days after operation. One-year survival rate of recipients and allografts was ~100 % (13/13) and ~92.3 % (10/13) respectively. Urine reflow occurred in 2 patients during a follow-up of 12 months. Conclusion The use of bladder flap for ureteral reconstruction is an effective technique for total autograft ureteral necrosis.

Adolescent ; Child ; Female ; Glomerulonephritis, IGA ; diagnosis ; pathology ; Humans ; Male ; Prognosis

Adult ; Aged ; Aged, 80 and over ; Biliary Tract Neoplasms ; complications ; Cholangitis ; etiology ; Cholestasis ; etiology ; therapy ; Drainage ; adverse effects ; Female ; Hepatic Encephalopathy ; etiology ; Humans ; Intraoperative Period ; Jaundice, Obstructive ; etiology ; therapy ; Liver Neoplasms ; complications ; Male ; Middle Aged ; Pancreatitis ; etiology ; Stents ; adverse effects

BACKGROUND: Biliary tract complications are one of the most common postoperative problems after liver transplantation.Balloon dilation and percutaneous transhepatic biliary drainage (PTBD) has become an effective method to improve biliary complication after orthotopic liver transplantation (OLT).OBJECTIVE: To evaluate the balloon dilation and PTBD in the treatment of biliary stricture after OLT through case follow up.DESIGN, TIME AND SETTING: A total of 53 consecutive patients underwent interventional procedures to treat biliary stricture after OLT in the Department of Radiology, Beijing Chaoyang Hospital, Capital Medical University from July 1999 to March 2007 and were recruited for this study. The series included 46 men and 7 women, with 17-64 years of age. After OLT transplantation, all patients had abnormally elevated serum bilirubin level, and confirmed to suffer from obstruction of biliary tract by CT or MRI examinations.METHODS: Of 50 patients who received PTBD treatment, 36 underwent PTBD through right bile duct, 14 underwent bilateral (right bile duct and left bile duct) PTBD with 6 patients through left bile duct in the second treatment. A total of 13 underwent balloon dilation, and 3 were subjected to balloon dilation alone.MAIN OUTCOME MEASURES: An averaged 9.6 months of follow up was performed in 53 patients to observe obstructive jaundice recurrence induced by abnormally elevated serum bilirubin level after percutaneous transhepatic biliary interventional procedures.RESULTS: Follow up results showed satisfactory clinical outcome with obstructive jaundice resolved in all patients, except one patient, who received treatment with T tube, died of acute rejection at month 1 during the follow up, and one patient with liver failure had extremely poor prognosis after discharge at month 1 during the follow up. Obstructive jaundice was recovered even healed and serum bilirubin level was decreased to normal level in 51 patients at the end of follow-up. Primary success rate was 79% (42 in 53 cases), and assisted success rate was 21%. The first interventional procedure failed to treat obstructive jaundice in 5 patients. Obstructive jaundice recurred after primary percutaneous procedure in other 6 cases. No procedure related severe complications happened.CONCLUSION: Balloon dilation and PTBD are safe to treat biliary tract complication after OLT, without complication.

Objective To analyze the occurrence of infections relative to percutanous biliary drainage(PTBD)or stenting for malignant obstructive jaundice and explore the therapy and prevention. Methods 181 patients(130 male and 51 female; median age 64.5 years old)with malignant biliary obstructive jaundice were investigated including 81 hepatobiliary cancers,42 pancreatico-ampullae tumors,58 gestro-intestinal portal lymphatic metastasis. All cases accepted PTBD or placement of metallic stents and the perioperative complications were recorded and analysed including the occurance and treatment. Results All cases accepted PTBD or stenting successfully. The perioperative biliary infection was the major complication including 50 out of 62 preoperative infected cases(34.25%). 18 cases(15.13%)suffered from biliary infection after operation with 13 under control,5 without control,4 complicated with pulmonary infection and 17(9.39%)died of serious biliary infections. Gram-negative bacilli and endotoxin were the main cause of the severe biliary infection. Postoperative mild pancreatitis occurred in 65 cases(35.91%)without severe necrotic changes and were cured after anti-inflammatory treatment. Hepatic abscess due to biliary leak occurred in 1 case(0.55%),and was cured by CT-guided drainage. Conclusion Biliary infection is the most common complication after interventional therapy and should be promptly under control for preventing mortality and prolonging survival. Simultaneously,acute pancreatitis should also be on alert but good prognosis would be obtained with apt therapy.(J Intervent Radiol,2007,16: 693-695)

Objective: To study the influence of high cell incubating temperature on AMP-activated protein kinase(AMPK) activity and lipid metabolites of piglets hepatocytes in vitro.Method: Primary hepatocytes of piglets about age 55d were separated and cultured under 37 ℃(control) or 42 ℃(heat stress).The anabolic and catabolic products of [14C]-oleic acid were detected for hepatocytes and culture media at 60min,120min and 180min.There were 9 replicates per time point.Result: Heat stress activated AMPK activity and enhanced fatty acid oxidation.The production of [14C]-CO2 and [14C]-acid soluble metabolites(ASM) was higher in heat stress group than in the control.At the same time,heat stress depressed the incorporation of [14C]-oleate into phospholipids,monoglycerides,triglycerides,cholesterol and cholesteryl ester.Conclusion: Heat stress activated AMPK activity and enhanced the formation of anabolic products and depressed catabolic products in piglets hepatocytes in vitro.

BackgroundIdiopathic epiretinal membranes(ERMs) is a common eye disease condition that leads to progressive decline of visual acuity. Studying the risk factors relating to this disease will shed light on its pathogenesis and allow opthalmologists to screen the affected individuals among the high-risk population and prepare for prevention and management strategies. ObjectiveThis survey was to investigate the risk factors of idiopathic ERMs in the population undergoing routine health check-ups. MethodsThe clinical data of idiopathic ERMs was obtained from the population of routine health check-ups in Peking Union Medical College Hospital from November 2009 to October 2010. The examination outcomes were compared between the individuals with and without idiopathic ERMs. The demographic and clinical factors associated with idiopathic ERMs were analyzed and assessed using univariate and multivariate logistic regression analyses. Result A total of 27 400 people were included in the survey and idiopathic ERMs were diagnosed in 76 cases. No obvious eye complaint was obtained from the idiopathic ERMs. The number of people affected with idiopathic ERMs was 12 ( 12/11 659 ) in the below 40 years group, 21 (21/4595) in the 51-60 years group and 32 (32/2544) in the over 60 years group. Hypertension, diabetes, diedyslipidemia, renal function insufficiency ,and cataract were found in 42％ ,5％ ,66％ ,6％ and 8％ of the patients, respectively. The univariate logistic regression analyses revealed that significant correlations were found between age,hypertension,hyperlipidemia and history of cataract( P＜0. 01 ). Multivariate regression models showed that the risk of idiopathic ERMs increased in age of 51-60( OR=2. 5,95％ CI:1. 2-5.4,P=0.02) and over 60 years( OR =7.3,95％ CI:3.4-15.6 ,P＜0.01 ) and patients suffering from hyperlipidemia ( OR--2. 1,95％ CI:1. 3-3.5, P＜0. 01 ). ConclusionsOver the age of 50 years and hyperlipidemia are primary risk factors of idiopathic ERM.

ObjectiveTo investigate the risk factors for percutaneous transhepatic biliary drainage (PTBD) related cholangitis in patients with malignant obstructive jaundice.MethodsOne hundred and fifty-four consecutive patients with malignant obstructive jaundice and without leukocytosis,fever and other manifestations of biliary tract infection received initial PTBD drainage.They were enrolled in this study.An uncontrolled prospective study was conducted of cholangitis occurrence within 30 days after PTBD.Twenty potential preoperative risk factors were assessed by univariate and multivariate analysis.ResultsFifty-five patients (55/154,35.7％ ) developed PTBD-related cholangitis,which composed of cholangitis group.Other patients composed of non-cholangitis group (99/154).The cholangitis-related mortality rate was 2.6％ (4/154).Intraoperative bile culture were performed for 131 patients (131/154),including 45 in cholangitis group and 86 in non-cholangitis group.Positive result occurred in 26 patients (26/45) in cholangitis group and 17 patients (17/86) in non-cholangitis group.There was statistical significant difference between these two groups ( x2 =19.357,P ＜ 0.01 ).By univariate analysis,diabetes ( x2 =10.470,P ＜ 0.01 ),Child-Pugh C grade ( x2 =36.324,P ＜ 0.01 ),undrained biliary duct ( x2 =9.540,P ＜0.01 ),external-internal drainage ( x2 =9.856,P ＜ 0.01 ),history of ERCP or cholangiojejunostomy (x2 =14.196,P＜0.01),QOL (t =-3.288,P ＜0.01),KPS(t =-2.099,P＜0.05),ALT (t =-2.112,P＜0.05),PT (t =-3.648,P ＜0.01),albumin (t =-2.071,P ＜0.05),WBC (t =2.022,P ＜ 0.05 ),proximal obstruction ( x2 =6.190,P ＜ 0.05 ) and cirrhosis ( x2 =5.439,P ＜ 0.05 )were significantly different between cholangitis group and non-cholangitis group.By multivariate analysis,diabetes ( OR =5.093,P ＜0.01 ),Child-Pugh C grade ( OR =13.412,P ＜0.01 ),undrained biliary duct ( OR =3.348,P ＜ 0.05 ),external-internal drainage ( OR =3.168,P ＜ 0.05 ) and history of ERCP or cholangiojejunostomy (OR =8.330,P ＜ 0.01 ) remained significant difference.ConclusionsPTBD is an effective and safe palliative treatment for patients with malignant obstructive jaundice.Sufficient preoperative preparation and effective control of risk factors may reduce the incidence of cholangitis after PTCD.

Objective To evaluate the multi-slice CT perfusion imaging in investigating whether edaravone can prevent and treat pulmonary thromboembolism ischemia-reperfusion injury(PTE-IRI).Methods Twenty mongrel canines were included.A Swan-Ganz catheter wag introduced into the right internal jugular vein using the Seldinger technique,and then was inserted into the pulmonary artery.Balloon occlusion of the right inferior lobe pulmonary artery for 4 h was followed by removing catheter and 4 h of reperfusion.Animals were divided into four groups of A(no edaravone during ischenmia and reperfusion),B(edaravone used only during ischemia),C(edaravone used during both ischemia and reperfusion)and D group(edaravone used only during reperfusion)(n=5 per group).Every group was divided into three time points including before ischemia,4 h after ischemia and 4 h after reperfusion.CT scan and CT perfusionwere performed at the three time points.The blood flow(BF),blood volume(BV)and mean transit time (MTT)of the bilateral inferior regional lung parenchyma were measured with the software of perfusion 3.Results CT examination showed pulmonary edema in the right inferior lung lobe at 4 h after reperfusion.(1)The BF and MTT of A,B,C and D group were[(259.4±15.7)ml·min-1·100 g-1,(293.7±7.9)ml·min-1·100 g-1,(379.4±14.5)ml·min-1·100 g-1,(382.5±16.6)ml·min-1·100 g-1]and[(3.1±0.2)s,(2.6±0.2)s,(2.2±0.1)s,(1.9±0.2)s]respectively at 4 h after reperfusion.The BF and MTT were statistically difierent(P＜0.01)between groups(A and B,A and C,A and D,B and C,B and D)except between group C and D(the P value＞0.05)at 4 h after reperfusion,but the BV was not statistically different between groups(P＞0.05).(2)The BF[(397.2±19.2)ml·min-1·100 g-1and(259.4±15.7)ml·min-1·100 g-1in group A,(393.2±16.1)ml·min-1·100 g-1and(293.7±7.9)ml·min-1·100 g-1 in group B]and MTT[(1.8±0.1)8 and (3.1±0.2)s in group A,(1.8±0.2)s and(2.6±0.2)s in group B]were statistically different(P＜0.01),but the BV[(12.0±0.9)ml/100 g and(12.2±1.0)ml/100 g in group A,(11.9±1.5)ml/100 g and(12.2±1.3)ml/100 g in group B]were not different(P＞0.05)between groups before ischemia and 4 h after ischemia.The BF.MTT and BV were not statistically significant between before ischemia and4 h after reperfusion in group C and D(P＞0.05).ConclusionsEdaravone can attenuate the degree of the PTE IRI.Multi-slice CT perfusion imaging can evaluate effect.