Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic pancreatic duct stent placement, Conventional treatment of acute pancreatitis in early phase.
- Who it may be relevant to
- Registry conditions: Acute Pancreatitis (AP). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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. - Drug Conventional treatment of acute pancreatitis in early phase
Infusion therapy, pain relief, nutritional support and surgical procedure if needed
Primary outcome measures
- Mortality rate [Time frame: From enrollment to the end of treatment at 3 months]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 6 centers
- City Clinical Hospital No. 4 — Perm
- Almazov National Medical Research Centre — Saint Petersburg
- The City Hospital of the Holy Martyr Elizabeth — Saint Petersburg
- I.I. Dzhanelidze research institute of emergency medicine — Saint Petersburg
- Mariinskaya Hospital — Saint Petersburg
- Volgograd State Medical University — Volgograd
China · 1 center
- Department of General Surgery, Sir Run Run Shaw Hospital — Hangzhou
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. PMID 31210778
- 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 availa PMID 22341094
Identifiers
NCT: NCT07093996 · 14061979