Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-02-01
Brief Title:
Early Pancreatic Stent Placement for Preventing PEP
Sponsor:
The First Affiliated Hospital of Anhui Medical University
Organization:
The First Affiliated Hospital of Anhui Medical University
Study Overview
Official Title:
Early Versus Late Pancreatic Stent Placement for Preventing Post-ERCP Pancreatitis a Multicentre Randomised Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVL
Brief Summary:
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 preventionAll 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 11 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 eg biliary stone removal or drainageThe 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
Detailed Description:
Patients with challenging biliary access using pancreatic guidewire-assisted method will be enrolled in the study Recruitment will take place among individuals referred to the four participating centers for therapeutic biliary procedures After obtaining signed consent forms participants who meet all the inclusion criteria and have no exclusion criteria will be randomly grouped with a 11 ratio into EPSP and LPSP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None