STENT VS. INDOMETHACIN FOR PREVENTING POST-ERCP PANCREATITIS:
THE SVI TRIAL
About the Trial
This study is supported by the National Institutes of Health (NIH). The purpose of the study, known as the SVI Trial, is to determine whether rectal indomethacin can minimize the need for pancreatic stent placement for preventing post-ERCP pancreatitis in patients at high risk for this complication. At 15 major academic medical centers across the country, the study aims to enroll a total of 2180 study participants. Get in touch with a member of our team to learn more about the SVI Trial.
Primary Study Objective: To determine whether rectal indomethacin alone is as effective as the combination of rectal indomethacin & a temporary pancreatic stent for preventing post-ERCP pancreatitis in high-risk cases.
Secondary Study Objective: To collect blood, urine, duodenal fluid, and stool from study participants that will fuel future research on post-ERCP pancreatitis and acute pancreatitis in general.
Patients undergoing ERCP who may require temporary pancreatic stent placement for the sole purpose of preventing pancreatitis.
WHAT IS PANCREATITIS?
Pancreatitis is inflammation and swelling of the pancreas. This is the most common and potentially dangerous complication of ERCP and can result in severe symptoms as well as a hospital stay for pain medications and IV fluids. While most patients recover from post-ERCP pancreatitis after a matter of days, some cases can be severe and last much longer, requiring a prolonged hospitalization and additional procedures.
ERCP is a procedure that combines upper gastrointestinal (GI) endoscopy and real-time x-rays to treat problems of the liver, bile duct, and pancreas. During the procedure, an endoscope (a long narrow flexible tube with a camera and light at its end) is passed into the mouth and down the esophagus to view the lining of the stomach and the first part of the small intestine (the duodenum). From here a small wire and catheter can be inserted into the bile duct and/or pancreas. The doctor can inject contrast dye into the ducts and takes x-ray pictures to show problems such as stones, strictures, or blockages. Some of these can be treated right away with other tools passed through the endoscope.
Why we are doing this study
Until recently, only temporary pancreatic stent placement had been shown to be effective in preventing post-ERCP pancreatitis. Pancreatic stent placement is common practice in the United States, however, it is technically challenging, time consuming, and costly. Additionally, every patient who receives a stent requires a follow-up x-ray to ensure that it has fallen out because it fails to pass spontaneously in 10-15% of cases. Recently, studies have demonstrated that indomethacin, a non-steroidal anti-inflammatory drug (NSAID) similar to ibuprofen, significantly reduces the incidence and severity of post-ERCP pancreatitis. Because of this, current standard practice is to both place a temporary pancreatic stent and give indomethacin to patients at high risk of developing post-ERCP pancreatitis. Since the advent of indomethacin, researchers are now wondering whether indomethacin alone is just as good as the combination of pancreatic stent placement and indomethacin.