NCT01257711 - 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)

Fukuhara K, Osugi H, Takada N, Takemura M, Higashino M, Kinoshita H
Reconstructive procedure after distal gastrectomy for gastric cancer that best prevents duodenogastroesophageal reflux. World J Surg. 2002 Dec;26(12):1452-7. Epub 2002 Oct 10.
Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H
Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carc
Mathias JR, Fernandez A, Sninsky CA, Clench MH, Davis RH
Nausea, vomiting, and abdominal pain after Roux-en-Y anastomosis: motility of the jejunal limb. Gastroenterology. 1985 Jan;88(1 Pt 1):101-7.
Nunobe S, Okaro A, Sasako M, Saka M, Fukagawa T, Katai H, Sano T
Billroth 1 versus Roux-en-Y reconstructions: a quality-of-life survey at 5 years. Int J Clin Oncol. 2007 Dec;12(6):433-9. Epub 2007 Dec 21.
Osugi H, Fukuhara K, Takada N, Takemura M, Kinoshita H
Reconstructive procedure after distal gastrectomy to prevent remnant gastritis. Hepatogastroenterology. 2004 Jul-Aug;51(58):1215-8.
Woodward A, Sillin LF, Wojtowycz AR, Bortoff A
Gastric stasis of solids after Roux gastrectomy: is the jejunal transection important? J Surg Res. 1993 Sep;55(3):317-22.
Yoshino K
[History of gastric cancer surgery]. Nihon Geka Gakkai Zasshi. 2000 Dec;101(12):855-60. Japanese.

A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer

Clinical trial NCT01257711 - References