Acute Pancreatitis (AP)NCT07093996
Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis
A study testing Endoscopic pancreatic duct stent placement and Conventional treatment of acute pancreatitis in early phase in people with Acute Pancreatitis (AP), run by Almazov National Medical Research Centre at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis (AP)
- What is being tested?
- Endoscopic pancreatic duct stent placement and Conventional treatment of acute pancreatitis in early phase
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Sep 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Russia6 sites
City Clinical Hospital No. 4
Perm
Vladimir A Samarcev, PhD, 89028017331, samarcev-v@mail.ru
Vladimir A Samarcev, PhD
Almazov National Medical Research Centre
Saint Petersburg, 195220
Pavel A Kotkov, MD, 89062619231, Kotkovdr@mail.ru
Badri V Sigua, PhD
The City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, 195220
Pavel A Kotkov, MD, 89062619231, Kotkovdr@mail.ru
Sergei V Petrov, PhD
I.I. Dzhanelidze research institute of emergency medicine
Saint Petersburg
Andrei E Demko, PhD, 89215649140, opmu@emergency.spb.ru
Andrei E Demko, PhD
Mariinskaya Hospital
Saint Petersburg
Ivan A Solov'yev, PhD, 89112411277, oog@mariin.ru
Ivan A Solov'yev, PhD
Volgograd State Medical University
Volgograd
Igor V Mikhin, PhD, 89023621757, post@volgmed.ru
Igor V Mikhin, PhD
China1 site
Department of General Surgery, Sir Run Run Shaw Hospital
Hangzhou
Yu Hong, PhD, 13605705907, blueyu000@zju.edu.cn
Yu Hong, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Pancreatitis (AP)
- Being tested
- Endoscopic pancreatic duct stent placement, Conventional treatment of acute pancreatitis in early phase
- Keywords
- acute pancreatitis, endoscopic pancreatic duct stent placement, pancreatic necrosis
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic pancreatic duct stent placementProcedure or surgery
Also called Wirsung stenting
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 phaseDrug
Also called Conservative treatment
Infusion therapy, pain relief, nutritional support and surgical procedure if needed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Endoscopic pancreatic duct stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Data will be tabulated and statistically analyzed in terms of percentages
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (8)
Incidence of complications associated with endoscopic pancreatic duct stent placement
Frequency of duodenal bleeding, duodenal perforation, unsuccessful major duodenal papilla canulation etc. Data will be tabulated and statistically analyzed in terms of percentages
Measured: From endoscopic pancreatic duct stent placement to 3 months
Rate of different pancreatic necrosis models
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
Measured: From enrollment to the 7th day of treatment
Average Balthazar computed tomography severity index (0-10)
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.
Measured: From enrollment to the 7th day of treatment
Average SOFA (Sequential Organ Failure Assessment Score) score (0-24)
Sequential Organ Failure Assessment Score. Data will be tabulated and statistically analyzed in terms of mean
Measured: From enrollment to the 7th day of treatment
Incidence of other surgical interventions
Frequency of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy. Data will be tabulated and statistically analyzed in terms of percentages
Measured: From enrollment to the end of treatment at 3 months
Number of participants with other surgical interventions
Number of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy
Measured: From enrollment to the end of treatment at 3 months
Length of hospital stay
Data will be tabulated and statistically analyzed in terms of length of hospital stay in days
Measured: From date of hospitalization until the date of discharge, assessed up to 3 months
Number of participants with manifestation of diabetes mellitus
Data will be tabulated and statistically analyzed in terms of percentages
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Pancreatitis (AP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almazov National Medical Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kotkov Pavel, Almazov National Medical Research Centre
- Investigators
- Badri V Sigua, PhD, Principal investigator, Almazov National Medical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093996
- Sponsor's protocol ID
- 14061979
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31210778ASGE 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.
PubMed 22341094
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis: International Multicenter Controlled Randomized Prospective Study Protocol
- ClinicalTrials.gov ID
- NCT07093996
- Acronym / sponsor ID
- 14061979
- Conditions
- Acute Pancreatitis (AP)
- Keywords
- acute pancreatitis, endoscopic pancreatic duct stent placement, pancreatic necrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Almazov National Medical Research CentreUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Сomparison group | Active comparator | Drug: Conventional treatment of acute pancreatitis in early phaseTreatment 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. |
| Study group | Experimental | Procedure: Endoscopic pancreatic duct stent placementAlong with the generally accepted complex of therapeutic measures, endoscopic pancreatic duct stent placement will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic pancreatic duct stent placementAlso: Wirsung stentingEndoscopic 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. | Procedure or surgery | Study group |
| Conventional treatment of acute pancreatitis in early phaseAlso: Conservative treatmentInfusion therapy, pain relief, nutritional support and surgical procedure if needed | Drug | Сomparison group |
Primary outcome
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
8 secondary outcomes
Incidence of complications associated with endoscopic pancreatic duct stent placement
Time frame: 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
Average Balthazar computed tomography severity index (0-10)
Time frame: 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
Incidence of other surgical interventions
Time frame: 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
Length of hospital stay
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 31210778Leppaniemi 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.
- Background: PubMed 22341094ASGE 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Badri V Sigua, PhD principal investigator
Almazov National Medical Research Centre
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic pancreatic duct stent placement and Conventional treatment of acute pancreatitis in early phase in people with Acute Pancreatitis (AP), run by Almazov National Medical Research Centre at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pavel A Kotkov, MD (89062619231, Kotkovdr@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: From enrollment to the end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07093996, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.