View clinical trials related to Post-ERCP Pancreatitis.
Filter by:Post-ERCP pancreatitis is one of the most common complications accounting for substantial morbidity and mortality. The incidence of post-ERCP pancreatitis (PEP) has been studied in several large clinical trials and ranges from 1.6-15%. However most studies have demonstrated rates around 5%. This complication alone is estimated to cost the US healthcare around $150 million annually. To prevent this complication several pharmacological agents have been studied and no medication has been proved to be consistently effective in preventing this complications. Cyclo-oxygenase, and phospholipase A2 pathways are believed to play an important role in the pathogenesis of acute pancreatitis and so non-steroidal anti-inflammatory drugs (NSAIDs) have been extensively studied in the prevention of post-ERCP pancreatitis. One of the landmark studies done on prophylactic NSAIDs for PEP showed that rectal indomethacin significantly reduce the incidence of PEP (PEP developed in 9.2% vs. 16.9% of indomethacin and placebo groups respectively). Since then the use of rectal NSAIDs has become a standard chemo-prophylaxis for prevention of PEP especially in high risk patients. However, newly published meta-analysis showed that the role of peri-procedural rectal Indomethacin is doubtful in patients with average risk for PEP. In this prospective randomized clinical study, we propose to study the effects of supplemental peri-operative oxygen on the incidence of PEP. The effects of high oxygen fraction (FIO2) has extensively been studied in reducing the incidence of surgical site infection, postoperative nausea, vomiting and to prevent postoperative atelectasis. Changing the FIO2 during a procedure can be a simple, inexpensive and low risk intervention to prevent post-procedure complications.
With the development of endoscopic technology, ERCP has been widely used in the diagnosis and treatment of pancreatobiliary diseases, and has become the first treatment for most of the biliary and pancreatic diseases. Postoperative ERCP pancreatitis (PEP) is the most common and serious complication after ERCP. The purpose of this study was to explore methods for preventing postoperative pancreatitis. 1. Participants: Patients with high-risk factors associated with PEP were included in the no-obvious patients who underwent therapeutic ERCP in our hospital from June 2018 to December 2019. 2. Research methods: Patients were randomly divided into indometacin suppositories, indomethacin suppositories and pancreatic stents. 3. Statistical methods: SPSS 13.0 statistical software was used. The measurement data was expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for count data.
Background: Pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality, and increased health care expenditures. Until recently, the only effective method of preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement (PSP), an intervention that is costly, time consuming, technically challenging, and potentially dangerous. The investigators recently reported the results of a large randomized controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (>80%) had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who received indomethacin alone were less likely to develop PEP than those who received a pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for underlying differences in subject risk. If indomethacin were to obviate the need for PSP, major clinical and cost benefits in ERCP practice could be realized. Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP pancreatitis in high-risk cases. Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared. In addition, the investigators will establish a quality-assured central repository of biological specimens obtained from study participants, permitting future translational research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms by which non-steroidal anti-inflammatory drugs prevent this complication.
It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients. However, the optimal dose required is not known. The purpose of this study is to determine whether a dose of 200 mg, administered as rectal suppositories, is more effective than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube with a camera is passed down the patient's throat and allows for evaluation of the bile duct and/or pancreatic duct. The most common side effect of this procedure is post-ERCP pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this complication than others. Our hypothesis is to compare the efficacy of these two dose regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the frequency and severity of post-ERCP pancreatitis in high-risk patients.
Pancreatitis is one of the major complications of ERCP. It has been shown that NSAIDs are potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. The only one study with IM diclofenac showed reduction of post-ERCP pancreatitis without SOD (sphincter of Oddi dysfunction) by subgroup analysis in small study population. Therefore the investigators must need large scaled randomized control study including of SOD.