| ?Background?Biliary stricture(BS)is a common indication of endoscopic retrograde cholangiopancreatography(ERCP).The etiology,clinical manifestation and therapeutic strategy of BS are distinct form other biliopancreatic diseases,furthermore,majority of malignant BS(MBS)patients were diagnosed in advanced stages of the disease,accompanied with more challenging ERCP procedure and dismal overall survival(OS).It remains unclear which patient-related or procedure-related factors may influence the occurrence of post-ERCP pancreatitis(PEP)and OS in BS patients.?Aims?1.To identify possible risk factors associated with PEP in BS,common bile duct stone(CBDS)and unselected patients.2.To investigate the natural history of MBS patients receiving conservative therapy after ERCP and establish a predictive model for OS.3.To compare performance of rotatable angled tip guidewire(RAGW)and straight tip guidewire(SGW)in superselective cannulation of intrahepatic duct(IHD).?Methods?1.From January 2010 to December 2014,data from consecutive patients with native papilla treated with ERCP in Xijing Hospital were retrospectively revieved.Risk factors for PEP were analysed by logistic regression method.2.This retrospective study enrolled MBS patients who underwent ERCP and conservative therapy in two tertiary ERCP centers in China.Predictive factors associated with OS were identified in the training cohort by stepwise multivariate COX regression analysis.A predictive model was then developed and externally validated in the validation cohort.3.All patients with hilar stricture(HS)and planned for bilateral stenting by ERCP were eligible for the study.We randomly assigned patients to RAGW group or SGW group in 1:1 ratio.After success cannulation of first IHD,operators manipulated superselection of contralateral IHD using allocated GW.The primary outcome was superselection success rate of contralateral IHD.The secondary outcomes were fluoroscopy time taken in superselection of contralateral IHD,procedure time taken in superselection of contralateral IHD,fluoroscopy time taken in superselection of bilateral IHD,clinical success rate of ERCP and rates of post-ERCP adverse events.?Results?1.3133 patients were eligible for our study.PEP incidnece was 6.8%(47/695)in BS group,significantly higer than 3.8%(71/1893)in CBDS group(P=0.001).For patien-related factors,PEP was associated with duodenal stenosis(OR,2.74;95%CI,1.14-6.59)and HS(OR,2.59;95%CI,1.41-4.77)in BS group.While female gender(OR,2.11;95%CI,1.20-3.73)and normal total bilirubin(TBIL)(OR,1.93;95%CI,1.13-3.32)were significant in CBDS group.For procedure-related factors,cannulation time?5 min(OR,2.38;95%CI,1.06-5.33)and precut(OR,3.20;95%CI,1.35-7.59)was independently associated with PEP in BS and CBDS group respectively.2.From January 2009 to December 2013,301 patients were eligible,152 in the training cohort and 149 in the validation cohort.Tumors mainly originated from bile duct(33.6%),pancreas(23.5%)or ampulla(20.4%).76.3%(116/152)of the patients died during the observational period.The median OS of training population was 5.0(95%CI,3.9-6.2)months.CA19-9?1000 U/m L,non-ampulla tumor,metastasis,preERCP total bilirubin?7 mg/dl and hilar stricture were identified as independent predictive factors of poor OS(all P<0.05).Based on these factors,the COMTH score was developed.The median OS of patients with COMTH>8 in the training and validation cohorts were both 3.0 months,which were significantly shorter than those with COMTH?8(10.0 and 6.9 months in the training and validation cohorts respectively,both P<0.001).3.Totally 38 patients with HS were enrolled and underwent prespecified interim analysis.Patients were randomly assigned to SGW group(n=19)or RAGW group(n=19).94.7%(36/38)of patients had MBS.Within 10 minutes,superselection success rates of contralateral IHD were 73.7%(14/19)in SGW group and 57.9%(11/19)in RAGW group(P=0.31)respectively.Fluoroscopy(96s vs 354 s,P=0.08)and procedure time(120s vs 573 s,P=0.23)taken in superselection,fluoroscopy time taken in superselection of bilateral bile duct(246s vs 402 s,P=0.31),clinical success rate(94.7% vs 78.9%,P=0.15)and overall post-ERCP adverse events rates(26.3% vs 26.3%,P=1.00)were all not significantly different between the two groups..?Conclusions?BS and CBDS patients had different patterns of risk factors for PEP,COMTH score was valuable for predicting survival of MBS patients who underwent ERCP and conservative therapy.The OS in patients with COMTH>8 were less than 3 months,indicating a higher cost-effective ratio of the implantation of plastic stents.Furthermore,outcomes of interim analysis were not power enough to demonstrate the superioty of RAGW compared with SGW in patients with HS.The study should be proceeded as planned initially. |
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