Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis
NCT ID: NCT07093996
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-09-01
2027-02-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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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.
Conventional treatment of acute pancreatitis in early phase
Infusion therapy, pain relief, nutritional support and surgical procedure if needed
Study group
Along with the generally accepted complex of therapeutic measures, endoscopic pancreatic duct stent placement will be performed
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.
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Presence of organ failure signs (moderate and severe pancreatitis)
3. Informed consent of the patient
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Almazov National Medical Research Centre
OTHER
Responsible Party
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Kotkov Pavel
MD, associate professor of the General Surgery Department Almazov National Medical Research Centre
Principal Investigators
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Badri V Sigua, PhD
Role: PRINCIPAL_INVESTIGATOR
Almazov National Medical Research Centre
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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14061979
Identifier Type: -
Identifier Source: org_study_id
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