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The research design is a randomized prospective clinical study comparing the incidence of Walled Off Necrosis (WON) in patients with acute necrotizing pancreatitis.
This is a randomized trial comparing the incidence of WON in patients with acute necrotizing pancreatitis, according to the placement or non-placement of an Advanix or a Cook Pancreatic Duct (PD) stent during Endoscopic Retrograde Cholangiopancreatography (ERCP) within 1-2 week of symptom onset. Patients will be randomly allocated to either treatment arm i.e. to either PD stent placement or no PD placement in a 1:1 ratio. The type of stent to be placed is at the discretion of the physician based on the clinical needs and presentation of the patient at the time of procedure. This is based on factors such as the size of the WON, the patient's anatomy, and other variables. Patients will be assessed at 4-6 weeks post-ERCP for the primary outcome measure, which is the incidence of WON on contrast-enhanced CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Duct Stent Placement | Active Comparator | Subject will have placement of either the Advanix or Cook Pancreatic Stent placed. |
|
| No Pancreatic Duct Stent Placement | Active Comparator | Subject will not have a pancreatic Duct stent placed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatic Duct Stent Placement | Device | Patients will be randomly allocated to either treatment arm to have a PD stent placed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of WON between the PD stent and no PD stent groups | The primary aim of the study is to compare the incidence of WON between the PD stent and no PD stent groups at 4-6 weeks post-index ERCP. | 4-6 weeks post-index ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of WON Intervention | Incidence of WON requiring intervention of any type (including endoscopic, surgical or interventional radiology interventions) | 6 weeks |
| Rates of DPDS | Incidence of DPDS, as determined by ERCP or Magnetic Resonance Cholangiopancreatography (MRCP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shyam Varadarajulu, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interventional Endoscopy - Florida Hospital | Orlando | Florida | 32803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23622135 | Background | Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068. | |
| 22885331 | Background | Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8. |
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No plan to share individual participant data.
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| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| No Pancreatic Duct Stent Placement | Other | Patients will be randomly allocated to either treatment arm and not receive PD placement. |
|
| 6 weeks |
| Number of patients with Adverse events | Incidence of procedure related adverse events | 6 weeks |
| Rates of additional interventions resulting from complications | Incidence of other interventions undertaken as clinically indicated for complications of acute pancreatitis | 6 weeks |
| Number of patients with Acute pancreatitis | Clinical adverse events related to underlying acute pancreatitis | 6 weeks |
| Number of patients with Local complications | Clinical adverse events arising as a result of local complications of acute pancreatitis | 6 weeks |
| Number of patients with Systemic complications | Clinical adverse events arising as a result of systemic complications of acute pancreatitis | 6 weeks |
| Length of stay | Duration of hospitalization in days | 6 weeks |
| Cost | Total hospital costs in US Dollars | 6 weeks |
| 23100216 | Background | Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25. |
| 23086243 | Background | Freeman ML, Werner J, van Santvoort HC, Baron TH, Besselink MG, Windsor JA, Horvath KD, vanSonnenberg E, Bollen TL, Vege SS; International Multidisciplinary Panel of Speakers and Moderators. Interventions for necrotizing pancreatitis: summary of a multidisciplinary consensus conference. Pancreas. 2012 Nov;41(8):1176-94. doi: 10.1097/MPA.0b013e318269c660. |
| 15704050 | Background | Garg PK, Madan K, Pande GK, Khanna S, Sathyanarayan G, Bohidar NP, Tandon RK. Association of extent and infection of pancreatic necrosis with organ failure and death in acute necrotizing pancreatitis. Clin Gastroenterol Hepatol. 2005 Feb;3(2):159-66. doi: 10.1016/s1542-3565(04)00665-2. |
| 24054878 | Background | Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063. |
| 25493375 | Background | Nadkarni NA, Kotwal V, Sarr MG, Swaroop Vege S. Disconnected Pancreatic Duct Syndrome: Endoscopic Stent or Surgeon's Knife? Pancreas. 2015 Jan;44(1):16-22. doi: 10.1097/MPA.0000000000000216. |
| 20410514 | Background | van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG; Dutch Pancreatitis Study Group. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010 Apr 22;362(16):1491-502. doi: 10.1056/NEJMoa0908821. |
| 17650935 | Background | Casas M, Mora J, Fort E, Aracil C, Busquets D, Galter S, Jauregui CE, Ayala E, Cardona D, Gich I, Farre A. [Total enteral nutrition vs. total parenteral nutrition in patients with severe acute pancreatitis]. Rev Esp Enferm Dig. 2007 May;99(5):264-9. doi: 10.4321/s1130-01082007000500004. Spanish. |
| 14526151 | Background | Gupta R, Patel K, Calder PC, Yaqoob P, Primrose JN, Johnson CD. A randomised clinical trial to assess the effect of total enteral and total parenteral nutritional support on metabolic, inflammatory and oxidative markers in patients with predicted severe acute pancreatitis (APACHE II > or =6). Pancreatology. 2003;3(5):406-13. doi: 10.1159/000073657. Epub 2003 Sep 24. |
| 16149365 | Background | Louie BE, Noseworthy T, Hailey D, Gramlich LM, Jacobs P, Warnock GL. 2004 MacLean-Mueller prize enteral or parenteral nutrition for severe pancreatitis: a randomized controlled trial and health technology assessment. Can J Surg. 2005 Aug;48(4):298-306. |
| 17164546 | Background | Petrov MS, Kukosh MV, Emelyanov NV. A randomized controlled trial of enteral versus parenteral feeding in patients with predicted severe acute pancreatitis shows a significant reduction in mortality and in infected pancreatic complications with total enteral nutrition. Dig Surg. 2006;23(5-6):336-44; discussion 344-5. doi: 10.1159/000097949. Epub 2006 Dec 12. |
| 23896955 | Background | Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30. |
| 22449657 | Background | Yi F, Ge L, Zhao J, Lei Y, Zhou F, Chen Z, Zhu Y, Xia B. Meta-analysis: total parenteral nutrition versus total enteral nutrition in predicted severe acute pancreatitis. Intern Med. 2012;51(6):523-30. doi: 10.2169/internalmedicine.51.6685. Epub 2012 Mar 15. |
| 14528225 | Background | Varadarajulu S, Noone T, Hawes RH, Cotton PB. Pancreatic duct stent insertion for functional smoldering pancreatitis. Gastrointest Endosc. 2003 Sep;58(3):438-41. doi: 10.1067/s0016-5107(03)00025-7. |
| 11448431 | Background | Lau ST, Simchuk EJ, Kozarek RA, Traverso LW. A pancreatic ductal leak should be sought to direct treatment in patients with acute pancreatitis. Am J Surg. 2001 May;181(5):411-5. doi: 10.1016/s0002-9610(01)00606-7. |
| 20189503 | Background | Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available. |
| 24079795 | Background | Varadarajulu S, Rana SS, Bhasin DK. Endoscopic therapy for pancreatic duct leaks and disruptions. Gastrointest Endosc Clin N Am. 2013 Oct;23(4):863-92. doi: 10.1016/j.giec.2013.06.008. Epub 2013 Jul 12. |