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ABSTRACT Background This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. Methods: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. Results: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. Conclusion: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020).
RESUMO Contexto: Este estudo randomizado, controlado multicêntrico e multinacional foi projetado para comparar a eficácia da indometacina supositório e N-acetil cisteína (NAC) para prevenção de pancreatite pós colangiografia endoscópica. Métodos: Durante um período de 6 meses, todos os pacientes submetidos à CPRE em sete centros de referência foram aleatoriamente atribuídos para receber 1200 mg de NAC oral, supositório de indometacina 100 mg, 1200 mg de NAC oral mais supositório de indometacina 100 mg ou placebo 2 horas antes do procedimento. Os resultados primários foram a taxa e a gravidade de qualquer pancreatite pós procedimento (PPP). Resultados: Um total de 432 pacientes foram incluídos (41,4% do sexo masculino). Eram originalmente cidadãos de seis países (60,87% caucasianos). Foram alocados aleatoriamente para receber NAC (grupo A, 84 casos), indometacina retal (grupo B, 138 casos), NAC + indometacina retal (grupo C, 115 casos) ou placebo (grupo D, 95 casos). A taxa de PPP nos grupos A, B e C em comparação com o placebo foi de 10,7%, 17,4%, 7,8% vs 20% (P=0,08, 0,614 e 0,01, respectivamente). Conclusão A NAC oral é mais eficaz do que a indometacina retal quando comparado ao placebo para prevenção de PPP e a combinação de NAC e indometacina teve a menor incidência de PPP e pode ter efeito sinérgico na sua prevenção de PPP. (IRCT20201222049798N1; 29/12/2020).
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OBJECTIVE:To evaluate the clinical efficacy of somatostatin and protease inhibitors in the prevention of post-ERCP pancreatitis(PEP)and hyperamylasemia(PEHA). METHODS:Retrieved from databases as Cochrane Library, PubMed,Embase,RCTs about therapeutic efficacy of somatostatin and protease inhibitors in the prevention of PEP were included. EndNote X8 software was used to eliminate duplicate documents,and the quality of included studies was evaluated according to Cochrane System Evaluator Manual version 5.3.3. Bayesian network Meta-analysis was conducted by MCMC method with R 3.4.3 software Gemtc 0.8 program package. Risk of bias was evaluated by using Rev Man 5.3 software,and risk of publication was evaluated by using Stata 14.0 software draws funnel map. RESULTS:A total of 33 RCTs were included,involving 10 576 patients,somatostatin,gabexate,ulinastatin,nafamostat. Network Meta-analysis showed that in the prevention of PEP,the order of curative effect was as follows:somatostatin(intravenous bolus)>nafamostat>ulinastatin>somatostatin(high-dose intravenous drip)>gabexate,somatostatin(low-dose intravenous drip)was ineffective. In the prevention of PEHA,the order of probability being somatostatin(high-dose intravenous drip)>somatostatin(intravenous bolus)>ulinastatin. Only nafamostat was effective in preventing PEP in high-risk patients. CONCLUSIONS:Compared with somatostatin(low-dose intravenous drip)and gabexate,somatostatin(intravenous bolus)and somatostatin(high-dose intravenous drip),ulinastatin,nafamostat can more effectively prevent PEP. Nafamostat cannot prevent PEHA,but can prevent PEP in high risk patients.
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Objective To investigate the risk factors for post-ERCP complications. Methods Data of the patients who underwent ERCP in the First Affiliated Hospital of Nanchang University from 1 January 2011 to 31 December 2013 were retrospectively analyzed. Post-ERCP complications were analyzed by univariate and multivariate analyses. Results A total of 277 patients out of 1 951 developed complications, 101(5.18%)pancreatitis, 54(2.77%)hyperamylasemia(not including pancreatitis), 134(6.87%) biliary infection,8(0.41%)hemorrhage,1(0.05%)obstruction and 1(0.05%)perforation.Multivariate analyses showed cholangiocarcinoma(P=0.002,OR=2.39, 95% CI:1.38-4.14), long operation time(>60 min)(P=0.020,OR=3.77,95%CI:1.23-11.53)and endoscopic sphincterotomy(EST)(P=0.008, OR=2.56,95% CI:1.28-5.14)and entrance of guidewire to pancreatic duct(P=0.012,OR=1.43, 95%CI:1.08-1.87)were independent risk factors for PEP. Cholangiocarcinoma(P<0.01, OR=2.93, 95%CI:1.88-4.56),multiple times of ERCP during the period of hospitalization(P<0.01, OR=2.53, 95%CI:1.63-3.93)were independent risk factors for post-cholangitis. However, EST(P=0.03, OR=0.65,95%CI:0.44-0.97)and antibiotics prophylaxis after ERCP(P=0.03, OR=0.64, 95% CI:0.39-0.95)were protective factors for post-cholangitis. ConclusionCholangiocarcinoma, endoscopic sphincterotomy, long operation time(> 60 min)and entrance of guidewire to pancreatic duct were independent risk factors for PEP. Cholangiocarcinoma and multiple ERCP during the period of hospitalization are independent risk factors for post-cholangitis.EST and antibiotics prophylaxis after ERCP might reduce the occurrence of cholangitis.
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Background:Pancreatitis is the main complication of ERCP,and a variety of risk factors will increase its risk. Studies showed that temporary pancreatic duct stent can reduce the incidence of post-ERCP pancreatitis (PEP). Aims:To study the efficacy and safety of prophylactic pancreatic duct stenting on preventing PEP in patients with risk factors. Methods:Patients undergone ERCP and accompanied with one or more PEP-associated risk factors from November 2013 to November 2016 at Huaibei People's Hospital were enrolled,and were divided randomly into pancreatic duct stenting group (observation group)and non-stenting group (control group). Serum levels of amylase at 4,24 and 48 hours after the procedure and incidence of PEP were compared between the two groups. Results:A total of 297 patients were enrolled, and 147 patients were in observation group,and 150 patients in control group. No significant differences in gender,age and ERCP disease spectrum were found between the two groups (P > 0. 05). Incidence of PEP was significantly decreased in observation group than in control group (6. 1％ vs. 16. 0％,P 0. 05). Conclusions:Prophylactic pancreatic duct stenting may decrease the incidence of PEP in patients accompanied with PEP-associated risk factors, especially could decrease the severity of PEP. However, the incidence of hyperamylasemia is not decreased.
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Objective To study the effect of indomethacin preventing post-ERCP pancreatitis ( PEP ) on the patients younger than 50 years undergoing small endoscopic sphincterotomy (sEST) combined with endoscopic papillary balloon dilation(EPBD) in the treatment of choledocholithiasis. Methods 202 patients younger than 50 years with choledocholithiasis were divided into two groups, 101 patients in treatment group before surgery were rectal administrated with indometacin, 101 patients in control group were administered with placebo, all patients underwent sEST combined with EPBD in the treatment of choledocholithiasis.After operation,the abdominal pain NRS score, amylase, incidence of pancreatitis and hospitalization time were recorded, and the rates of heartburn, rash, gastrointestinal bleeding were recorded.Results In the treatment group, pain NRS score 24 hours after operation was(0.327 ±0.763), amylase 24 hours after operation was (116.87 ±113.97) U/L, there were 3 cases of postoperative pancreatitis (2.97%) in the treatment group,and the postoperative hospitalization time was (6.42 ±2.11) days.In the control group, pain NRS score 24 hours after operation was ( 0.634 ±1.027 ) , amylase 24 hours after operation was ( 185.38 ±160.60 ) U/L, there were 11 cases of postoperative pancreatitis (10.89%) in the control group, and the postoperative hospitalization time were (7.29 ±2.71) days.The differences of NRS pain score, amylase, incidence of pancreatitis, postoperative hospitalization time between these two groups were statistically significant ( P<0.05 ) .The differences of the rates of postoperative heartburn, rash, gastrointestinal bleeding between these two groups were not statistically significant.Conclusion Indomethacin rectal administration can prevent post-ERCP pancreatitis ( PEP ) on the patients who undergoing sEST combined with EPBD in the treatment of choledocholithiasis,and this administration is quite security.
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Objective To evaluate the role of pancreatic duct stenting in the prevention of post-endoscopic retrograde cholangio-pancreatography (ERCP) pancreatitis (PEP).Methods The literature and corresponding references of randomized controlled trials (RCT) on pancreatic duct stenting for the prevention of PEP were searched from Cochrane Library (1970 to Aug. 2015), PubMed (1966 to Aug. 2015), EMBASE (1966 to Aug. 2015) and China Biology Medicine disc (1978 to Aug. 2015). Literature screening, data extraction, and methodological quality assessment were individually performed by two researchers.The software RevMan 5.3 of Cochrane Collaboration was used for statistical analysis. Results A total of 23 articles with 2556 patients were included in the present study. The result of Meta analysis showed that: compared with the control, pancreatic duct stenting could effectively prevent PEP (RR=0.34, 95%CI: 0.27-0.43, P<0.00001) from occurrence and alleviate the severity of PEP (RR=0.18, 95%CI: 0.08-0.42, P<0.0001). Conclusion Pancreatic duct stenting may effectively prevent the occurrence and alleviate the severity of PEP.
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Objective A prospective randomized controlled trial was carried out to explore the best time of In-domethacin suppositories administration for the prevention of post-ERCP pancreatitis in high-risk groups. Methods 81 patients were enrolled in the study finally. Patients were randomized into group A (100 mg rectal Indomethacin suppositories was administrated immediately after ERCP), group B (100 mg rectal Indomethacin suppositories was administrated half an hour after ERCP) and group C (ERCP alone group, which did not give Indomethacin supposito-ries). The level of serum amylase, urine amylase, serum CRP, serum IL-6, serum TNF-α were measured before, 3 h, 24 h and 48 h after ERCP, and the incidence of PEP and hyperamylasemia were analyzed. Results There was 1 case (4.00%) of PEP in group A, 2 cases (5.41%) of PEP in group B and 5 cases (26.31%) of PEP in group C;the incidences of PEP of group A and group B were significant lower than that in group C (P < 0.05). There was 1 case (4.00%) of hyperamylasemia in group A, 5 cases (13.51 %) of hyperamylasemia in group B and 6 cases (31.6 %) of hyperamylasemia in group C, and the incidences of hyperamylasemia of group A and group B were significant lower than that in group C ( P< 0.05). Conclusion Administration of 100 mg Indomethacin suppositories immediately or half an hour after ERCP can effectively reduce the incidence of PEP and hyperamylasemia.
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Contexto: La pancreatitis aguda es la complicación más frecuente de la PCRE y algunos factores de riesgo son asociados con el desarrollo de hiperamilasemia y pancreatitis post PCRE. Objetivos: Identificar factores nuevos asociados con hiperamilasemia y pancreatitis post PCRE en pacientes que acudieron a nuestro centro. Material y métodos: Un estudio retrospectivo de cohorte se llevó a cabo en 170 pacientes en quienes se realizó una CPRE diagnóstico-terapéutica por enfermedad biliopancreática. 67 pacientes desarrollaron hiperamilasemia (39,4%) y 6 pancreatitis post PCRE (3,5%). Se aplicaron los siguientes criterios diagnósticos: Hiperamilasemia: elevación de la amilasa sérica por encima del valor normal (90IU).Pancreatitis aguda post PCRE: dolor abdominal continuo por más de 24 horas y elevación de la amilasa tres veces por encima del valor normal. Resultados: El número de canulaciones, más de 4 (19 pacientes), (p=0,006; RR= 3,00) se asoció significativamente con el desarrollo de la hiperamilasemia y la puesta de stents biliares (14 pacientes) se asoció como un factor protector (p=0,00; RR= 0,39). Los factores asociados con el desarrollo de la pancreatitis post PCRE se relacionaron con el paciente (localización peridiverticular de la papila (p=0,00; RR= 2,00) y disfunción del Esfinter de Oddi (p=0,000; RR=1,20). Conclusiones: Factores técnicos fueron asociados con el desarrollo de la hiperamilasemia, sin embargo, los relacionados con el desarrollo de la pancreatitis post PCRE fueron mayoritariamente relacionados al paciente.
Context: Acute pancreatitis is the most common complication in ERCP, and some risk factors were associated with the development of hyperamylasemia and post-ERCP pancreatitis. Objectives: identifying new factors associated with the development of hyperamylasemia or post-ERCP pancreatitis in patients attended at our center. Material and methods: A (retrospective) cohort study was carried out in 170 patients on which a diagnostic-therapeutic ERCP was done due to biliopancreatic disease. 67 patients developed hyperamylasemia (39.4%) and 6 post-ERCP pancreatitis (3.5%). The following diagnostic criteria were applied: Hyperamylasemia: increase in the serum amylase level above the normal value (90I/U). Acute post-ERCP pancreatitis: clinical: continuous abdominal pain for over 24 hours and biochemical: elevation of amylase 3 times above normal value (90U/I). Results: The number of cannulations more than 4 (19 patients), (p=0.006; RR= 3.00) was associated significantly with the development of hyperamylasemia and the placing of biliary stent (14 patients), (p=0.00; RR= 0.39) was a protective factor. The factors associated with the development of post-ERCP pancreatitis were related with the patient (peridiverticular location of the papilla (p=0.00; RR= 2.00) and the sphincter of Oddi dysfunction (p=0.000; RR=1.20). Conclusion: Technical factors were associated with the development of hyperamylasemia, however, the factors associated with the development of post-ERCP pancreatitis in our universe of study were related mainly with the patient.
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Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Young Adult , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Hyperamylasemia/epidemiology , Hyperamylasemia/etiology , Pancreatitis/epidemiology , Pancreatitis/etiology , Cohort Studies , Cuba , Retrospective Studies , Risk FactorsABSTRACT
Pancreatitis is the most frequent and distressing complication of endoscopic retrograde cholangiopancreatography (ERCP). Many recent studies have reported the use of pharmacological agents to reduce post-ERCP pancreatitis (PEP); however, the most effective agents have not been established. Reduction in the incidence of PEP in high-risk patients has been reported through specific cannulation techniques such as guide wire-assisted cannulation and the use of pancreatic stents. The present review focuses on ERCP techniques for the prevention of PEP.
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Humans , Catheterization , Cholangiopancreatography, Endoscopic Retrograde , Incidence , Pancreatitis , StentsABSTRACT
Objective To evaluate the effect of indomethacin in the prevention of post ERCP pancreatitis (PEP) .Methods The literatures and corresponding references of randomized controlled trials (RCT ) on indomethacin in the prevention of PEP were searched from Cochrane Library (Jan 1970 to June 2013) ,Pubmed(Jan 1966 to June 2013) ,EMBASE(Jan 1966 to June 2013)and China Biology Medicine disc(Jan 1978 to June 2013) .Literature screening ,data extraction and methodological quality assessment were individually performed by two researchers .The software RevMan 5 .2 of Cochrane Collaboration was used for statistical analy‐sis .Results A total of 7 trails ,2170 patients were included in this study .Meta analysis results showed:indomethacin could effec‐tively prevent from PEP (RR=0 .45 ,95% CI:0 .33-0 .60 ,P<0 .05) and Hyperamylasemia (RR=0 .51 ,95% CI:0 .37-0 .70 ,P<0 .05) compared with placebo ,and could effectively alleviate the severity of pancreatitis after ERCP (RR=0 .43 ,95% CI:0 .23 -0 .78 ,P<0 .05) .Conclusion Indomethacin could effectively prevent from PEP and Hyperamylasemia ,and could effectively alleviate the severity of PEP .
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Objective To investigate the efficacy of pancreatic duct stent in preventing post-ERCP pancreatitis (PEP) of difficult bile duct cannulation.Methods A total of 120 patients who underwent difficult bile duct cannulation during routine ERCP were randomized to receive pancreatic duct stent placement (S group) or not (NS group),and the incidence of PEP,hyperamylasemia and scores of abdominal pain were analyzed.Results There were 15 cases of hyperamylasemia and 5 cases of PEP occurred in S group,but no severe PEP was observed.The score of abdominal pain was (3.82 ± 1.48) in S group.There were 18cases of hyperamylasemia and 14 cases of PEP occurred,including 2 severe PEP in NS group.The score of abdominal pain was (7.48 ± 1.93) in NS group.There was no significant difference in the incidence of hyperamylasemia between the two groups (P ＞ 0.05).The incidence of PEP,severe PEP and the scores of abdominal pain were lower in the S group (P ＜ 0.05).Conclusion Placement of pancreatic duct stent can reduce the PEP rate of difficult bile duct cannulation and relieve the abdominal pain.
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Objectives To evaluate the efficacy of rectally administered indomethacin for the prevention of post-ERCP pancreatitis(PEP).Methods All eligible patients without high risk factors such as heart,lung,liver and kidney,coagulation dysfunction,without malignant disease and contraindication for NSAIDs,and pre-operative imaging study and lab test suggesting no pancreatitis,aged from 18 ～ 75 who underwent ERCP and EST were enrolled.In a randomized prospective trial,patients were randomized to receive a suppository containing indomethacin,100 mg,or an identical placebo 30 minutes after ERCP.PEP was diagnosed when there was pancreatitis related clinical symptoms,and serum amylase was higher than 3 times of the normal values,and when the patient needed more than 1 day hospitalization.Patients with PEP were evaluated with APACHE Ⅱ score 72 hours after ERCP.Results During 2004 ～ 2010,a total of 348 patients were enrolled,of which 182 received indomethacin and 166 received placebo.Six patients developed pancreatitis in the indomethacin group and 14 in the placebo group (3.3％ vs.8.4％,P ＜0.05),and the difference between the two group was statistically significant ( P ＜ 0.05 ).In those patients with PEP,the APACHE Ⅱ scores in indomethacin group (4.3 ± 1.3 ) were lower than that in the placebo group (7.4 ±1.7),and the difference between the two groups was statistically significant ( P ＜ 0.05 ).The incidence of hyperamylasemia in both groups was not statistically significant (9.3％ vs.10.8％,P ＞ 0.05 ).Conclusions This trial shows that rectally administered indomethacin after ERCP and EST can effectively reduce the incidence and severity of PEP.
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BACKGOUND/AIMS: Pancreatitis is the most common and important complication of an endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study was to identify risk factors for post ERCP-pancreatitis in patients pretreated with nafamostat mesilate, a synthetic protease inhibitor. METHODS: A total of 247 patients who underwent an ERCP were evaluated prospectively. Potential risk factors of post-ERCP pancreatitis in patients pretreated with nafamostat mesilate were evaluated. RESULTS: Twenty-four patients (9.7%) and nine patients (3.6%) developed post-ERCP hyperamylasemia and pancreatitis, respectively. As determined by univariate analysis among the potential risk factors, we found a procedure time over 20 minutes, pancreatic duct cannulation over four times, prior post-ERCP pancreatitis and the absence of a common bile duct (CBD) stone as risk factors for post-ERCP hyperamylasemia. We also found a patient age under 60 years, a procedure time over 20 minutes, pancreatic duct cannulation over four times and the absence of a CBD stone as risk factors for post-ERCP pancreatitis (p<0.05). As determined by multivariate analysis, pancreatic cannulation over four times is independently associated with post-ERCP hyperamylasemia (p=0.038; OR, 5.165; 95% CI, 1.093~24.412) and post-ERCP pancreatitis (p=0.002; OR, 33.122; 95% CI, 3.526~311.138). CONCLUSIONS: A repeated pancreatic duct cannulation is the most important risk factor for post-ERCP pancreatitis in patients pretreated with nafamostat mesilate.
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Humans , Catheterization , Cholangiopancreatography, Endoscopic Retrograde , Common Bile Duct , Guanidines , Hyperamylasemia , Mesylates , Multivariate Analysis , Pancreatic Ducts , Pancreatitis , Prospective Studies , Protease Inhibitors , Risk FactorsABSTRACT
Post-ERCP pancreatitis(PEP) is the most common and serious complications about endoscopic retrograde cholangiopancreatography(ERCP).A number of studies have been confirmed that PEP can be prevented by pancreatic stents.We summarized earlier results in this field to expand the clinical use for this high-tech.