NCT02573389 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

ASGE Technology Assessment Committee, Pfau PR, Pleskow DK, Banerjee S, Barth BA, Bhat YM, Desilets DJ, Gottlieb KT, Maple JT, Siddiqui UD, Tokar JL, Wang A, Song LM, Rodriguez SA
Pancreatic and biliary stents. Gastrointest Endosc. 2013 Mar;77(3):319-27. doi: 10.1016/j.gie.2012.09.026. Review. Erratum in: Gastrointest Endosc. 2013 Jul;78(1):193-5.
Jin T, Altaf K, Xiong JJ, Huang W, Javed MA, Mai G, Liu XB, Hu WM, Xia Q
A systematic review and meta-analysis of studies comparing laparoscopic and open distal pancreatectomy. HPB (Oxford). 2012 Nov;14(11):711-24. doi: 10.1111/j.1477-2574.2012.00531.x. Epub 2012 Aug 7. Review.
Reddymasu SC, Pakseresht K, Moloney B, Alsop B, Oropezia-Vail M, Olyaee M
Incidence of pancreatic fistula after distal pancreatectomy and efficacy of endoscopic therapy for its management: results from a tertiary care center. Case Rep Gastroenterol. 2013 Aug 16;7(2):332-9. doi: 10.1159/000354136. eCollection 2013.
Rieder B, Krampulz D, Adolf J, Pfeiffer A
Endoscopic pancreatic sphincterotomy and stenting for preoperative prophylaxis of pancreatic fistula after distal pancreatectomy. Gastrointest Endosc. 2010 Sep;72(3):536-42. doi: 10.1016/j.gie.2010.04.011. Epub 2010 Jul 3.
Schoellhammer HF, Fong Y, Gagandeep S
Techniques for prevention of pancreatic leak after pancreatectomy. Hepatobiliary Surg Nutr. 2014 Oct;3(5):276-87. doi: 10.3978/j.issn.2304-3881.2014.08.08. Review.

A Pilot Study on the Effect of Transampullary Pancreatic Duct Stenting on Postoperative Pancreatic Fistula Rate After Distal Pancreatectomy

Clinical trial NCT02573389 - References