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

July 28, 2025 updated by: Kotkov Pavel, Almazov National Medical Research Centre

Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis: International Multicenter Controlled Randomized Prospective Study Protocol

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Endoscopic pancreatic duct stent placement is used to treat a variety of pancreatic diseases, including chronic pancreatitis, Wirsung duct strictures, pseudocysts in disconnected duct syndrome and as a preventive measure after endoscopic retrograde cholangiopancreatography. Despite the obvious progress, the greatest number of unsolved problems remain in the issues of using this manipulation in patients with acute pancreatitis. In particular, the perspectives of the pancreatic duct stent placement in treatment of acute pancreatitis early stages remain controversial.

On the one hand, the installation of a stent in the early acute pancreatitis stages helps to normalize the outflow of pancreatic juice from the pancreas and reduce intraductal pressure, leading to a beneficial effect, as evidenced by a number of researchers. On the other hand, stent placement may partially block the second-order pancreatic ducts or increase the risk of sterile pancreatitis contamination due to the development of reflux. In addition, one should not forget about a number of post-manipulation complications inherent in this procedure, including bleeding from the area of the major duodenal papilla, perforation of the duodenum, progression of pancreatic necrosis and cholangitis. Finally, the timing and indications for early endoscopic stenting of the pancreatic duct are not currently standardized, largely due to the fact that acute pancreatitis is a pathological condition that is difficult to predict.

Thus, although this manipulation seems perspective, due to the lack of evidence base, it is currently difficult to recommend it for use in wide clinical practice.

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Hangzhou, China
        • Department of General Surgery, Sir Run Run Shaw Hospital
        • Contact:
        • Principal Investigator:
          • Yu Hong, PhD
        • Sub-Investigator:
          • Lou Songmei, PhD
        • Sub-Investigator:
          • Guo Feng, PhD
        • Sub-Investigator:
          • Song Shuping, PhD
        • Sub-Investigator:
          • Litian Ye, PhD
        • Sub-Investigator:
          • Shen Bo, PhD
  • Russian Federation
      • Perm, Russian Federation
        • City Clinical Hospital No. 4
        • Contact:
        • Principal Investigator:
          • Vladimir A Samarcev, PhD
        • Sub-Investigator:
          • Aleksei A Parshakov
        • Sub-Investigator:
          • Natalia V Lozhkina
      • Saint Petersburg, Russian Federation, 195220
        • Almazov National Medical Research Centre
        • Contact:
        • Principal Investigator:
          • Badri V Sigua, PhD
        • Sub-Investigator:
          • Andrei B Singayevskiy, PhD
        • Sub-Investigator:
          • Pavel A Kotkov, MD
      • Saint Petersburg, Russian Federation, 195220
        • The City Hospital of the Holy Martyr Elizabeth
        • Contact:
        • Sub-Investigator:
          • Pavel A Kotkov, MD
        • Principal Investigator:
          • Sergei V Petrov, PhD
        • Sub-Investigator:
          • Andrei V Vovk, MD
        • Sub-Investigator:
          • Denis A Chernyshov, MD
        • Sub-Investigator:
          • Oleg Yu Orlov
        • Sub-Investigator:
          • Rishat R Fevziev
      • Saint Petersburg, Russian Federation
        • I.I. Dzhanelidze research institute of emergency medicine
        • Contact:
        • Principal Investigator:
          • Andrei E Demko, PhD
        • Sub-Investigator:
          • Evgenii V Batig, MD
        • Sub-Investigator:
          • Musa I Safoev, MD
        • Sub-Investigator:
          • Ekaterina A Nikolaeva, MD
      • Saint Petersburg, Russian Federation
        • Mariinskaya Hospital
        • Contact:
          • Ivan A Solov'yev, PhD
          • Phone Number: 89112411277
          • Email: oog@mariin.ru
        • Principal Investigator:
          • Ivan A Solov'yev, PhD
        • Sub-Investigator:
          • Maria V Antipova, MD
        • Sub-Investigator:
          • Maxim Yu Pletnev
        • Sub-Investigator:
          • Shamsi Z Amari
        • Sub-Investigator:
          • Aleksei A Gusev
      • Volgograd, Russian Federation
        • Volgograd State Medical University
        • Contact:
        • Principal Investigator:
          • Igor V Mikhin, PhD
        • Sub-Investigator:
          • Denis V Mikhaylov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Сomparison group
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
Infusion therapy, pain relief, nutritional support and surgical procedure if needed
Other Names:
  • Conservative treatment
Experimental: Study group
Along with the generally accepted complex of therapeutic measures, endoscopic pancreatic duct stent placement will be performed
Procedure: 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.
Other Names:
  • Wirsung stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: From enrollment to the end of treatment at 3 months
Data will be tabulated and statistically analyzed in terms of percentages
From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications associated with endoscopic pancreatic duct stent placement
Time Frame: From endoscopic pancreatic duct stent placement to 3 months
Frequency of duodenal bleeding, duodenal perforation, unsuccessful major duodenal papilla canulation etc. Data will be tabulated and statistically analyzed in terms of percentages
From endoscopic pancreatic duct stent placement to 3 months
Rate of different pancreatic necrosis models
Time Frame: From enrollment to the 7th day of treatment

Will be evaluated according CT-imaging:

Model 1 - volume of pancreatic necrosis < 30%, or not determined Model 2 - volume of pancreatic necrosis 30-50%, located in the distal pancreatic part Model 3 - volume of pancreatic necrosis 30-50% located in the proximal part Model 4 - volume of pancreatic necrosis 30-50% and more with separation of viable proximal and distal parts (disconnected duct syndrome) Data will be tabulated and statistically analyzed in terms of percentages
From enrollment to the 7th day of treatment
Average Balthazar computed tomography severity index (0-10)
Time Frame: From enrollment to the 7th day of treatment
A scoring system used to assess the severity of acute pancreatitis based on computed tomography scans. Data will be tabulated and statistically analyzed in terms of mean.
From enrollment to the 7th day of treatment
Average SOFA (Sequential Organ Failure Assessment Score) score (0-24)
Time Frame: From enrollment to the 7th day of treatment
Sequential Organ Failure Assessment Score. Data will be tabulated and statistically analyzed in terms of mean
From enrollment to the 7th day of treatment
Incidence of other surgical interventions
Time Frame: From enrollment to the end of treatment at 3 months
Frequency of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy. Data will be tabulated and statistically analyzed in terms of percentages
From enrollment to the end of treatment at 3 months
Number of participants with other surgical interventions
Time Frame: From enrollment to the end of treatment at 3 months
Number of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy
From enrollment to the end of treatment at 3 months
Length of hospital stay
Time Frame: From date of hospitalization until the date of discharge, assessed up to 3 months
Data will be tabulated and statistically analyzed in terms of length of hospital stay in days
From date of hospitalization until the date of discharge, assessed up to 3 months
Number of participants with manifestation of diabetes mellitus
Time Frame: From enrollment to the end of treatment at 3 months
Data will be tabulated and statistically analyzed in terms of percentages
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Almazov National Medical Research Centre

Investigators

  • Principal Investigator: Badri V Sigua, PhD, Almazov National Medical Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 6, 2025

First Submitted That Met QC Criteria

July 28, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14061979

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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