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Early Pancreatic Stent Placement for Preventing PEP

NCT06250803 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 768

Last updated 2025-03-13

No results posted yet for this 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).

Conditions

  • Cholangiopancreatography, Endoscopic Rretrograde
  • Post-ERCP Pancreatitis

Interventions

DEVICE

early pancreatic stent placement (EPSP)

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Anqing Municipal Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wannan Medical College

    collaborator OTHER

  • Tongcheng People's Hospital of Anhui province

    collaborator UNKNOWN

  • Fuyang people's hospital

    collaborator OTHER

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-03-01
Completion
2026-03-01
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250803 on ClinicalTrials.gov