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

NCT07093996 | Not Yet Recruiting

• 1 other identifier: 14061979
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Acute Pancreatitis (AP)

Keywords

acute pancreatitis; endoscopic pancreatic duct stent placement; pancreatic necrosis

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  Data will be tabulated and statistically analyzed in terms of percentages

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (8)

• Incidence of complications associated with endoscopic pancreatic duct stent placement

  From endoscopic pancreatic duct stent placement to 3 months

• Rate of different pancreatic necrosis models

  From enrollment to the 7th day of treatment

• Average Balthazar computed tomography severity index (0-10)

  From enrollment to the 7th day of treatment

• Average SOFA (Sequential Organ Failure Assessment Score) score (0-24)

  From enrollment to the 7th day of treatment

• Incidence of other surgical interventions

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Сomparison group

ACTIVE COMPARATOR

Treatment measures will be performed in accordance with clinical guidelines and will include infusion therapy, pain relief, and nutritional support. Surgical interventions will also be performed based on estimated indications.

Drug: Conventional treatment of acute pancreatitis in early phase

Study group

EXPERIMENTAL

Along with the generally accepted complex of therapeutic measures, endoscopic pancreatic duct stent placement will be performed

Procedure: Endoscopic pancreatic duct stent placement

Interventions

Endoscopic pancreatic duct stent placement PROCEDURE

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.

Also known as: Wirsung stenting

Study group

Conventional treatment of acute pancreatitis in early phase DRUG

Infusion therapy, pain relief, nutritional support and surgical procedure if needed

Also known as: Conservative treatment

Сomparison group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acute pancreatitis confirmed on the basis of at least 2 of the 3 diagnostic criteria according to the revised Atlanta classification
• Presence of organ failure signs (moderate and severe pancreatitis)
• Informed consent of the patient

You may not qualify if:

• 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.)
• Previous surgical interventions on the major duodenal papilla
• Diverticula of the major duodenal papilla
• Pregnancy
• Shock
• Coagulopathy (INR\>1.5, blood platelets \< 50\*109/l

Sponsors & Collaborators

• Almazov National Medical Research Centre: lead

Study Sites (7)

Department of General Surgery, Sir Run Run Shaw Hospital

Hangzhou, China

Location

City Clinical Hospital No. 4

Perm, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, 195220, Russia

Location

The City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, 195220, Russia

Location

I.I. Dzhanelidze research institute of emergency medicine

Saint Petersburg, Russia

Location

Mariinskaya Hospital

Saint Petersburg, Russia

Location

Volgograd State Medical University

Volgograd, Russia

Location

Related Publications (2)

• Leppaniemi A, Tolonen M, Tarasconi A, Segovia-Lohse H, Gamberini E, Kirkpatrick AW, Ball CG, Parry N, Sartelli M, Wolbrink D, van Goor H, Baiocchi G, Ansaloni L, Biffl W, Coccolini F, Di Saverio S, Kluger Y, Moore E, Catena F. 2019 WSES guidelines for the management of severe acute pancreatitis. World J Emerg Surg. 2019 Jun 13;14:27. doi: 10.1186/s13017-019-0247-0. eCollection 2019.

  PMID: 31210778 BACKGROUND

• ASGE Standards of Practice Committee; Anderson MA, Fisher L, Jain R, Evans JA, Appalaneni V, Ben-Menachem T, Cash BD, Decker GA, Early DS, Fanelli RD, Fisher DA, Fukami N, Hwang JH, Ikenberry SO, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Shergill AK, Dominitz JA. Complications of ERCP. Gastrointest Endosc. 2012 Mar;75(3):467-73. doi: 10.1016/j.gie.2011.07.010. No abstract available.

  PMID: 22341094 BACKGROUND

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Badri V Sigua, PhD

  Almazov National Medical Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavel A Kotkov, MD

CONTACT

89062619231; Kotkovdr@mail.ru

Badri V Sigua, PhD

CONTACT

89111979343; dr.sigua@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, associate professor of the General Surgery Department Almazov National Medical Research Centre

Model Details: Randomized controlled trial Masking: not provided (open allocation). Given the specific nature of the medical discipline being studied, blinding of participants, as well as allocation concealment, is not planned due to the practical impossibility of this procedures. Randomization method: calendar, according to which patients born in an even year will be distributed into the study group, and those born in an odd year - into the comparison group.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (6); CN (1)