NCT Number: NCT06250803
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
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 1:1 ratio) into EPSP and LPSP
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants who fulfill all the below criteria will be enrolled: 1. with naive papilla; 2. over 18 years; 3. undergoing ERCP with pancreatic guidewire-assisted technique for biliary access; 4. providing a signed, written informed consent.
Exclusion criteria
Participants who meet any of the following criteria will be excluded: 1. unreachable main papillae; 2. surgically altered gastrointestinal anatomy; 3. concurrent acute pancreatitis; 4. biliary cannulation over pancreatic duct stent after precut sphincterotomy or wire-guided method (native early attribute); 5. failed biliary cannulation; 6. severe active cardiopulmonary disease; 7. breastfeeding or pregnancy; 8. ampullary tumour.
In 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.
Other names: late pancreatic stent placement (EPSP)
Time frame: up to 1 months
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.
Time frame: up to 1 months
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.
Time frame: Intra-procedure
Time frame: within 30 days after ERCP
During the 30-day follow-up period,we will record other ERCP-related AEs such as gastrointestinal bleeding, cholangitis, and gastrointestinal perforation etc.
Contact information is provided by the study sponsor or research team.
Junjun Bao, MD
CONTACT
Qiao Mei, MD
CONTACT
The First Affiliated Hospital of Anhui Medical University
Other
Early Versus Late Pancreatic Stent Placement for Preventing Post-ERCP Pancreatitis: a Multicentre, Randomised Trial
Acronym: EVL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07088757
Post-ERCP Pancreatitis
Shanghai, China
View Trial DetailsNCT07661498
Digestive System Diseases, Pancreatic Diseases
San Francisco, California, United States
View Trial DetailsNCT07346365
ERCP, Pancreas Stent
Frankfurt, Germany
View Trial DetailsNCT07247682
Post-ERCP Pancreatitis
Hefei, Anhui, China
View Trial Details