Post-ERCP Pancreatitis

The goal of this clinical trial is to learn if a single intravenous dose of tacrolimus, given before an ERCP procedure (an endoscopic procedure of the bile ducts and pancreas), can prevent post-ERCP pancreatitis (PEP) in adults at moderate-to-high risk of developing this complication. The main question it aims to answer is: * Does a single dose of tacrolimus lower the number of participants who develop pancreatitis after ERCP? Researchers will compare tacrolimus to a placebo (a look-alike solution with no active drug) to see if tacrolimus reduces the occurrence of PEP. Participants will: * Receive an intravenous infusion of either tacrolimus or placebo, given over 60 minutes, ending before the start of the ERCP procedure * Receive standard preventive treatment (a rectal anti-inflammatory medication (NSAID)) in addition to the study infusion * Be contacted by phone 48 hours after the procedure to check for symptoms * Complete questionnaires about quality of life and healthcare use, and be followed for 12 weeks after the procedure * The first 40 enrolled patients will have extra blood samples taken to measure tacrolimus levels.

Post-ERCP pancreatitis (PEP) is the most common serious adverse event after endoscopic retrograde cholangiopancreatography (ERCP), occurring in roughly 7-15% of patients. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and peri-procedural aggressive intravenous hydration each reduce PEP, but published hydration regimens are delivered over 8-24 hours and require an overnight hospital stay, which is impractical where ERCP is increasingly performed as a same-day procedure. This multicentre, prospective, randomised controlled trial tests whether a short (under 4 hours) aggressive hydration regimen with Lactated Ringer's solution, combined with rectal indomethacin, is superior to standard care (rectal indomethacin plus low-volume hydration) for preventing PEP, while supporting same-day discharge. Adults undergoing ERCP are randomised 1:1. The primary outcome is the incidence of PEP defined by consensus (Cotton) criteria. A total of 1300 participants (650 per arm) will be enrolled.

Endoscopic retrograde cholangiopancreatography (ERCP) is an essential diagnostic and therapeutic tool used to manage diseases of the pancreatic and biliary systems. During the procedure, an upper endoscope is used to reach the major duodenal papilla, and a contrast material is injected into the ducts for radiologic imaging. In an endoscopic sphincterotomy, a specialized knife cuts the biliary sphincter to treat papilla conditions or facilitate therapeutic interventions. The most common complication following an ERCP is pancreatitis, carrying an incidence rate of 3.5% to 9.7%. Standard preventive strategies currently include careful patient selection, rectal administration of NSAIDs (like indomethacin or diclofenac), aggressive intravenous hydration, and pancreatic stent placement. The Innovation: Flushing the ampulla with ice-cold water after a sphincterotomy is a safe,easy, and cost-effective evolving intervention. While initial data demonstrates its safety,there is a clear deficiency in multicenter randomized trials assessing its overall clinical effectiveness, and no such studies have been conducted in the Gulf region. The primary goal of this study is to evaluate the effectiveness of ice-cold water flushing ofthe ampulla after endoscopic sphincterotomy in reducing the incidence of post-ERCP pancreatitis.

This study is a randomized clinical trial evaluating the efficacy of rectal indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients undergoing biliary ERCP who have a history of prior biliary sphincterotomy. While rectal indomethacin has demonstrated benefits in preventing post-ERCP pancreatitis in high-risk patients, its utility in this specific patient subgroup remains unclear. This trial aims to determine whether prophylactic administration of indomethacin offers a measurable benefit over no intervention in this lower-risk population. Eligible patients will be identified prior to their scheduled biliary ERCP and screened for inclusion criteria. Following informed consent, participants will be randomized to receive either rectal indomethacin or no indomethacin prior to the procedure.

A multicenter, prospective, controlled randomized study to investigate the optimal duration of protective pancreatic stents after endoscopic retrograde cholangiopancreatography (ERCP). The primary endpoint is the complication rate that can be clinically attributed to the remaining pancreatic prosthesis or its removal in the study groups. Secondary endpoints are spontaneous removal of the pancreatic stent, length of hospital stay, rate of follow-up examinations per group, influencing factors, and a possible exploratory analysis.

Our aim is to compare the efficacy of 100 mg versus 200 mg rectal indometacin in preventing post-ERCP pancreatitis (PEP) among high-risk patients without no pancreatic stenting. The 100 mg versus 200 mg indometacin trial is a multicentre, single-blind, randomized controlled study. High-risk patients for PEP without pancreatic stent insertion will be informed about the opportunity to participate. A total of 1,036 eligible patients will be randomly assigned in a 1:1 ratio to one of two groups: (1) administration of 100 mg rectal indometacin immediately after ERCP (standard-dose group), or (2) administration of 200 mg rectal indometacin immediately after ERCP (high-dose group). The primary outcome is the incidence and severity of PEP. Secondary outcomes include hyperamylasemia and other ERCP-related adverse events (AEs).

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks. This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation. The results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.

Our aim is to compare early versus late pancreatic stent placement in preventing PEP among patients with naive papilla. The EVL trial will provide essential answers regarding the optimal timing of prophylactic pancreatic stent placement in PEP prevention.All patients with difficult biliary cannulation undergoing endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic guidewire-assisted technique for biliary access will be told about the opportunity to participate in EVL research. In total, 768 patients will be randomly assigned (1:1) to two arms: (1) early pancreatic stent placement (EPSP) (a pancreatic stent will be placed immediately after endoscopic retrograde cholangiography (ERC) or endoscopic sphincterotomy (EST)) and (2) late pancreatic stent placement (LPSP) (a pancreatic stent will be placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage).The primary outcome is the rate and severity of PEP. The secondary outcomes are hyperamylasemia, the rate of stenting success, and other ERCP-related adverse events (AEs).

Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP. The comparative effectiveness of the two methods has however not been studied. It is argued that in the context of indomethacin, the placement of a PDS is unnecessary. Advocates for PDS insertion however believe that mechanical decompression of the pancreatic duct is critical in the prevention of pancreatitis. The investigators propose a multi-centre randomised controlled trial to compare the use of rectal indomethacin to PDS insertion in high risk patients in the prevention of PEP.