Pancreatic Duct Stent for Acute Necrotizing Pancreatitis
NCT ID: NCT03115918
Last Updated: 2022-02-17
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1 participants
INTERVENTIONAL
2016-08-04
2020-11-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Disconnected Pancreatic Duct
NCT03436043
A Phase II Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
NCT03174353
Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention
NCT04113499
Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis
NCT05043415
Comparison of FCSEMS and Plastic Stents
NCT02685865
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pancreatic Duct Stent Placement
Subject will have placement of either the Advanix or Cook Pancreatic Stent placed.
Pancreatic Duct Stent Placement
Patients will be randomly allocated to either treatment arm to have a PD stent placed.
No Pancreatic Duct Stent Placement
Subject will not have a pancreatic Duct stent placed.
No Pancreatic Duct Stent Placement
Patients will be randomly allocated to either treatment arm and not receive PD placement.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pancreatic Duct Stent Placement
Patients will be randomly allocated to either treatment arm to have a PD stent placed.
No Pancreatic Duct Stent Placement
Patients will be randomly allocated to either treatment arm and not receive PD placement.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
3. The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
4. All patients with acute necrotizing pancreatitis and bedside index for severity in acute pancreatitis (BISAP) score of ≥ 3, who have been referred to Florida Hospital for Percutaneous endoscopy gastrojeunostomy (PEG-J) tube placement and/or ERCP for assessment of the PD
5. Absence of pancreatic fluid collection (defined as those \> 3cm in size located along the course of the main PD on cross-sectional imaging) at the time of study enrollment
6. No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP
Exclusion Criteria
2. Unable to obtain consent for the procedure from either the patient or LAR
3. Patients with acute interstitial pancreatitis, without pancreatic necrosis
4. Patients with BISAP score ≤ 2
5. Patients with pancreatic fluid collection \> 3cm in size located along the course of the main PD on cross-sectional imaging prior to the initial ERCP
6. Patients with DPDS on cross-sectional imaging or ERCP
7. Unable to safely undergo ERCP for any reason
8. Failed cannulation during ERCP
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AdventHealth
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shyam Varadarajulu, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
922733
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.