Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Pancreatitis is the most important complication of ERCP. The severity of this condition
varies from mild to severe and can lead to prolonged hospitalization, surgical interventions,
and even death. Several patient-related and procedure related factors have been identified
that are associated with a higher risk of post-ERCP pancreatitis. So far, several methods
have been proposed to avoid pancreatitis in patients at higher risk of this complication.
Several studies have shown that different drug therapies (indomethacin suppository, a
sublingual nitrate tablet and the administration of intravenous Ringer's solution) each may
reduce the incidence of post-ERCP pancreatitis. All these drug therapies are safe, cheap and
easy to administer.
Several other studies have shown that pancreatic duct stenting (placement of a plastic tube
in the pancreatic duct) is an effective intervention in preventing and reducing the severity
of post-ERCP pancreatitis, especially in high-risk groups. However, there are still a few
drawbacks to consider with pancreatic duct stenting: there are some difficulties with
insertion of a PD stent, it is associated with a need for radiological follow-up and/or
repeat endoscopy for removal, higher cost and a small but important risk of complications
(e.g. stent migration).
Most of the clinical trials of pancreatic duct stenting were performed, before the results of
trials of drug therapies were available. Moreover, no RCT (to the investigators knowledge)
has compared the efficacy of pancreatic duct stenting in patients who already received a
combination of drug therapies to prevent post-ERCP pancreatitis in high-risk patients. The
purpose of this study is to determine the noninferiority of a combination of drug therapies
in relation to pancreatic duct stenting to prevent post-ERCP pancreatitis in high-risk
patients.