About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
early pancreatic stent placement (EPSP)
DeviceIn the EPSP group, a single pig-tail pancreatic stent (5Fr) will be inserted instantly after ERC or EST, and subsequent biliary procedures will proceed as planned. In contrast, in the LPSP group, while keeping the PD guidewire in place, a single pig-tail PD stent (5Fr) will be ultimately placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage.
Treatment groups
Trial outcomes
Primary outcomes
The incidence and severity of post-ERCP pancreatitis
Patients were identified as post-ERCPpancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
Secondary outcomes
the incidence of hyperamylasemia
Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ERCP levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion.
the rate of stenting success
the incidence of other ERCP-related adverse events
During the 30-day follow-up period,we will record other ERCP-related AEs such as gastrointestinal bleeding, cholangitis, and gastrointestinal perforation etc.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Anhui Medical University
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Collaborator
Anqing Municipal Hospital
Collaborator
First Affiliated Hospital of Wannan Medical College
Collaborator
Tongcheng People's Hospital of Anhui province
Collaborator
Fuyang people's hospital
Collaborator