NCT02142517 - 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)

Bai XL, Zhang Q, Masood N, Masood W, Gao SL, Zhang Y, Shahed S, Liang TB
Duct-to-mucosa versus invagination pancreaticojejunostomy after pancreaticoduodenectomy: a meta-analysis. Chin Med J (Engl). 2013 Nov;126(22):4340-7.
Bassi C, Falconi M, Molinari E, Mantovani W, Butturini G, Gumbs AA, Salvia R, Pederzoli P
Duct-to-mucosa versus end-to-side pancreaticojejunostomy reconstruction after pancreaticoduodenectomy: results of a prospective randomized trial. Surgery. 2003 Nov;
El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T
Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single cen
Hayashibe A, Kameyama M
The clinical results of duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy in consecutive 55 cases. Pancreas. 2007 Oct;35(3):273-5.
Hosotani R, Doi R, Imamura M
Duct-to-mucosa pancreaticojejunostomy reduces the risk of pancreatic leakage after pancreatoduodenectomy. World J Surg. 2002 Jan;26(1):99-104. Epub 2001 Nov 26.
Zhang JL, Xiao ZY, Lai DM, Sun J, He CC, Zhang YF, Chen S, Wang J
Comparison of duct-to-mucosa and end-to-side pancreaticojejunostomy reconstruction following pancreaticoduodenectomy. Hepatogastroenterology. 2013 Jan-Feb;60(121):176-9.

Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy: A Prospective Randomized Study

Clinical trial NCT02142517 - References