Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis

NCT07093996 · tracked via the Priya Life Science China tracker

Sponsor

Almazov National Medical Research Centre

Phase

Not applicable

Started

2025-09-01

Last updated

2025-07-30

Condition(s) studied

Acute Pancreatitis (AP)

Investigational drug(s) / intervention(s)

Endoscopic pancreatic duct stent placementConventional treatment of acute pancreatitis in early phase

Endoscopic pancreatic duct stent placement: Endoscopic pancreatic duct stent placement will be performed with a 5Fr Boston Scientific pancreatic stent (3-4 cm in length) within 24 hours from the randomization procedure. The stent will be removed on the 5th day after installation.

Conventional treatment of acute pancreatitis in early phase: Infusion therapy, pain relief, nutritional support and surgical procedure if needed

Study summary

The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Diagnosis of acute pancreatitis confirmed on the basis of at least 2 of the 3 diagnostic criteria according to the revised Atlanta classification 2. Presence of organ failure signs (moderate and severe pancreatitis) 3. Informed consent of the patient Exclusion Criteria: 1. Presence of other indications for endoscopic intervention on the major duodenal papilla (biliary pancreatitis with cholangitis, calculus of the major duodenal papilla, stenosis of the major duodenal papilla, etc.) 2. Previous surgical interventions on the major duodenal papilla 3. Diverticula of the major duodenal papilla 4. Pregnancy 5. Shock 6. Coagulopathy (INR\>1.5, blood platelets \< 50\*109/l

Primary outcome measure(s)

Mortality rate — From enrollment to the end of treatment at 3 months
Data will be tabulated and statistically analyzed in terms of percentages

Trial sites (7)

Facility	City	Region
Department of General Surgery, Sir Run Run Shaw Hospital	Hangzhou	China
City Clinical Hospital No. 4	Perm	Russia
Almazov National Medical Research Centre	Saint Petersburg	Russia
The City Hospital of the Holy Martyr Elizabeth	Saint Petersburg	Russia
I.I. Dzhanelidze research institute of emergency medicine	Saint Petersburg	Russia
Mariinskaya Hospital	Saint Petersburg	Russia
Volgograd State Medical University	Volgograd	Russia

Other trials for the same condition

Retrospective Analysis of Acute Pancreatitis After Percutaneous Mechanical Thrombectomy In Treatment Of Thrombotic Disorders Recruiting

Multicenter Prospective Cohort Study of Hypertriglyceridemia Acute Pancreatitis Enrolling by invitation

Endocrine and Exocrine Secretory Function Alterations After Moderately Severe and Severe Acute Pancreatitis Active, not recruiting

Bowel Sound in Predicting the Severity of Acute Pancreatitis: Protocol of a Prospective, Multi-center Study Recruiting

Comparison of MIPPED-C and Surgical Necrosectomy in Pancreatic Necrosis Outcomes Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07093996 on ClinicalTrials.gov ↗ ← All trials in China