Early Pancreatic Stent Placement for Preventing PEP

Last updated: March 12, 2025
Sponsor: The First Affiliated Hospital of Anhui Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Treatment

early pancreatic stent placement (EPSP)

Clinical Study ID

NCT06250803
PJ 2023-14-12
  • Ages > 18
  • All Genders

Study 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 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

Inclusion

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

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.

Study Design

Total Participants: 768
Treatment Group(s): 1
Primary Treatment: early pancreatic stent placement (EPSP)
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
March 01, 2026

Study 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 1:1 ratio) into EPSP and LPSP

Connect with a study center

  • Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Active - Recruiting

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