NCT01400100 - 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)

Belyaev O, Herden H, Meier JJ, Muller CA, Seelig MH, Herzog T, Tannapfel A, Schmidt WE, Uhl W
Assessment of pancreatic hardness-surgeon versus durometer. J Surg Res. 2010 Jan;158(1):53-60. doi: 10.1016/j.jss.2008.08.022. Epub .
Foitzik T, Gock M, Schramm C, Prall F, Klar E
Octreotide hardens the pancreas. Langenbecks Arch Surg. 2006 Apr;391(2):108-12. Epub 2006 Mar 28.
Konstadoulakis MM, Filippakis GM, Lagoudianakis E, Antonakis PT, Dervenis C, Bramis J
Intra-arterial bolus octreotide administration during Whipple procedure in patients with fragile pancreas: a novel technique for safer pancreaticojejunostomy. J Surg Oncol. 2005 Mar 15;89(4):268-72.

Changes in Pancreatic Texture After Single-shot Administration of 500 µg Octreotide in the Gastroduodenal Artery During Pancreatoduodenectomy - a Double-Blinded Randomized Controlled Trial

Details for clinical trial NCT01400100

Clinical trial NCT01400100 - References