Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Study group | Experimental | Along with the generally accepted complex of therapeutic measures, endoscopic pancreatic duct stent placement will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Data will be tabulated and statistically analyzed in terms of percentages | From enrollment to the end of treatment at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From endoscopic pancreatic duct stent placement to 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavel A Kotkov, MD | Contact | 89062619231 | Kotkovdr@mail.ru | |
| Badri V Sigua, PhD | Contact | 89111979343 | dr.sigua@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Badri V Sigua, PhD | Almazov National Medical Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, Sir Run Run Shaw Hospital | Hangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31210778 | Background | 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. | |
| 22341094 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
|
| Conventional treatment of acute pancreatitis in early phase | Drug | Infusion therapy, pain relief, nutritional support and surgical procedure if needed |
|
|
| 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 |
| 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. | 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 | 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 | 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 | 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 | 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 | From enrollment to the end of treatment at 3 months |
| City Clinical Hospital No. 4 | Perm | Russia |
|
| Almazov National Medical Research Centre | Saint Petersburg | 195220 | Russia |
|
| The City Hospital of the Holy Martyr Elizabeth | Saint Petersburg | 195220 | Russia |
|
| I.I. Dzhanelidze research institute of emergency medicine | Saint Petersburg | Russia |
|
| Mariinskaya Hospital | Saint Petersburg | Russia |
|
| Volgograd State Medical University | Volgograd | Russia |
|
| 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. |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D019283 | Pancreatitis, Acute Necrotizing |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided