Randomized clinical trial to assess the efficacy of ulinastatin for postoperative pancreatitis following pancreaticoduodenectomy.
OBJECTIVE
Ulinastatin, an intrinsic trypsin inhibitor, has proved to be effective for the prevention of acute pancreatitis after endoscopic retrograde cholangiopancreatography. The aim of this study was to assess the efficacy of ulinastatin for postoperative pancreatitis following pancreaticoduodenectomy in a randomized clinical trial.


METHODS
Patients undergoing pancreaticoduodenectomy were randomized to receive perioperative ulinastatin or placebo. Levels of serum amylase, drain amylase, and urine trypsinogen-2 were measured.


RESULTS
A total of 42 patients were enrolled (20 in the ulinastatin group, 20 in the placebo group, 2 excluded). Two patients in the ulinastatin group and nine patients in the placebo group developed hyperamylasemia (P = 0.013) No patient in the ulinastatin group and five patients in the placebo group developed pancreatitis (P = 0.016). One patient in the ulinastatin group and two patients in the placebo group developed grade A pancreatic fistula (P = 0.548). Serum amylase levels at 4 hr and postoperative days 1, 2, and 3, and drain amylase levels on days 2 and 3 were significantly lower in the ulinastatin group than in the placebo group.


CONCLUSIONS
Prophylactic administration of ulinastatin reduced the levels of serum and drain amylase and the incidence of postoperative pancreatitis following pancreaticoduodenectomy.
Department of Surgery, Graduate School of Biochemical Sciences, Hiroshima University, Hiroshima, Japan. umk@hiroshima-u.ac.jp
Kenichiro
K
Uemura
Yoshiaki
Y
Murakami
Yasuo
Y
Hayashidani
Takeshi
T
Sudo
Yasushi
Y
Hashimoto
Hiroki
H
Ohge
Taijiro
T
Sueda
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000681:Amylases / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006023:Glycoproteins / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016577:Pancreaticoduodenectomy / Q000009:adverse effects*; D010195:Pancreatitis / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome; D014357:Trypsin / Q000652:urine; D014361:Trypsin Inhibitors / Q000627:therapeutic use*; D014362:Trypsinogen / Q000652:urine
D006023:Glycoproteins; D014361:Trypsin Inhibitors; C064831:PRSS2 protein, human; D014362:Trypsinogen; D000681:Amylases; D014357:Trypsin; C028665:urinastatin