18 Clinical Trials for Various Conditions
The aim of this study is to use a validated patient-reported outcome measure to evaluate how many patients have symptoms of pancreatitis after ERCP and how it correlates with their quality of life and productivity.
This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).
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.
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common, serious complication of ERCP. More than 500,000 ERCP procedures are performed from which 25,000 cases of PEP occur in the U.S.A. annually. PEP accounts for significant morbidity and health care expenditures. While symptoms of PEP arise immediately after ERCP, they are non-specific. Consequently, unnecessary admissions of outpatients without PEP and inadvertent discharge of outpatients with PEP from ERCP recovery are common. An accurate, confirmatory test for diagnosis of PEP immediately after ERCP is lacking. Actim Pancreatitis (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a biomarker for acute pancreatitis. Urine Trypisinogen-2 Dipstick test (UTDT) is a simple, inexpensive test with promising preliminary data for accuracy for immediate diagnosis of PEP. Prior studies of ITDT test characteristics lack rigorous scientific design. Investigators will enroll 1825 ERCP outpatients at our institution in a prospective cohort study. A pre-ERCP UTDT test and diagnostic UTDT 2 hours after the ERCP will be performed. Patients with a positive baseline UTDT will be followed clinically as part of this study without 2 hour testing. Care providers and study primary investigators will be blinded to the 2 hour UTDT results. Baseline, intra-procedure and recovery room clinical data will be recorded. Diagnosis of PEP will be made blinded to the UTDT result. Admission status for PEP will be assessed by review of records and phone/e-mail contact 5 days and 30 days after ERCP procedure. Sensitivity and specificity of 2 hour post ERCP UTDT for the diagnosis of PEP will be calculated. Aims: 1) To determine the test characteristics of UTDT for the diagnosis of PEP 2 hours after completion of ERCP. 2) To identify and describe patients with baseline UTDT positivity, in whom this test offers limited utility. Specific Aims: Primary Aim 1.1 To determine the test characteristics (sensitivity and specificity) of the UTDT for the diagnosis of PEP: Hypotheses: 1. UTDT is a sensitive and specific test for the diagnosis of PEP for patients undergoing ERCP. 2. At a cutpoint for a negative test of \<50ug/L, UTDT will be accurate at 2 hours post ERCP in patients whose baseline test is negative.
Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.
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.
Determine if IV ketorolac is an effective agent in the prevention of post-ERCP pancreatitis. Determine if IV ketorolac provides improved post-procedure analgesia. Determine if systemic mediators of inflammation are reduced in patients receiving IV ketorolac following ERCP.
Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately 11% of children undergoing the procedure. By definition it leads to prolongation of hospital stay or delays in care and rarely can result in long-term morbidity or even death. Recent adult trials have demonstrated prevention of PEP with administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed in children thus no "gold standard" or even commonly accepted method of preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages over rectally administered NSAIDs in the pediatric population in that it would allow for more consistent weight based dosing and would have more predictable absorption compared to suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical Center Dallas over a two-year period. The primary outcome measurement will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.
This research is being done to see if using a combination of rectal indomethacin and epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).
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.
1. ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of the bile duct as well as to manage leaks which occurs following laparoscopic gallbladder removal. 2. Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and results in considerable suffering and cost. 3. Patients with acute pancreatitis are treated with fluids. 4. Our aim is to assess whether prophylactic treatment with aggressive intravenous hydration prevents ERCP pancreatitis. 5. In a blinded fashion patients will be randomized to aggressive intravenous versus moderate hydration during and aftere ERCP for standard clinical indications. Our hypothesis is that prophylactic treatment with aggressive intravenous hydration protects against ERCP pancreatitis.
The purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ERCP pancreatitis.
The purpose of this research study is to determine if indomethacin, an anti-inflammatory medication in a class of medications known at NSAIDs (non-steroidal anti-inflammatory drugs) can reduce the risk of pancreatitis after Endoscopic Retrograde Cholangio-Pancreatography (ERCP.) The hypothesis is that indomethacin decreases the incidence and severity of post-ERCP pancreatitis. Patients who are scheduled to undergo a ERCP will be enrolled. Following ERCP, patients will be randomized to receive a dose of indomethacin or placebo (an inactive substance) instilled into the duodenum via the biopsy channel of the duodenoscope. All patients will be observed for 4 hours following ERCP which is part of routine clinical practice. Patients with minimal pain will be discharged after this 4 hour observation period. All patients will have baseline serum amylase levels which are repeated 2 to 4 hours after the ERCP has been completed. Patients who have significant abdominal pain will be hospitalized and evaluated for pancreatitis. Patients discharged to home will be contacted by telephone the following day to ask them if they have had any complications of ERCP.
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct. Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure that can be complicated by post-ERCP pancreatitis (PEP). Indomethacin and ketorolac are two medications used to prevent PEP. The main reason for this research study is to compare the effectiveness these drugs at reducing rates of PEP. There have been no studies comparing the effectiveness of these medications in preventing PEP in pediatric patients. You are being asked to take part in this research study because you are scheduled to have an ERCP as part of your medical care.
A difficult cannulation has been identified as one of the high risk factors for developing post-ERCP pancreatitis (PEP). The accessibility and morphology of the papilla influence the level of cannulation difficulty. The use of a forceps to assist in the cannulation is a demonstrated effective technique for cannulating papillae that are difficult to access. Thus, the objective of our study is to determine whether a forceps assisted cannulation leads to less difficult cannulation during ERCP. Because difficult cannulation is associated with increased risk of PEP, our study investigates whether the forceps assisted cannulation also reduces the incidence of PEP as a secondary outcome. Eligible patients who have consented will either be randomized to cannulation with forceps or cannulation with no forceps.
The purpose of this study is to document clinical utility and distribution of indications for short term pancreatic stenting, and stent type preference by indication at tertiary referral centers with expertise in pancreatic endotherapy.
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.