Prospective, randomized, double-blind, placebo-controlled trial of ulinastatin for prevention of hyperenzymemia after double balloon endoscopy via the antegrade approach.
BACKGROUND
Double balloon endoscopy (DBE) allows the entire small intestine to be viewed using a combination of antegrade and retrograde approaches. Acute pancreatitis is a serious complication of antegrade DBE with no effective prophylactic treatment currently available. Ulinastatin has been shown to be effective for the prevention of pancreatitis following endoscopic retrograde cholangiopancreatography. We therefore assessed the efficacy of ulinastatin for hyperenzymemia after antegrade DBE.


METHODS
Forty-four patients were enrolled in this prospective, randomized, double-blind, placebo-controlled trial. Patients in the ulinastatin group received 150 000 U ulinastatin by i.v. drip infusion for 2 h from the start of the procedure. Serum concentrations of pancreatic amylase and lipase were measured before and 3 and 18 h after antegrade DBE.


RESULTS
The study was terminated after interim analysis. Of the 44 patients, 23 were randomized to ulinastatin and 21 to placebo.The groups were similar with regard to sex ratio, age, type of endoscope, insertion time, total procedure time, number of endoscope pull-back procedures, and baseline pancreaticamylase and lipase concentrations. Post-DBE hyperenzymemia was observed in 35.0% and 47.8% of patients in the placebo and ulinastatin groups, respectively. The higher frequency of hyperenzymemia in the ulinastatin group was unexpected, but the difference was not statistically significant. One patient in the placebo group (5.0%) and none in the ulinastatin group experienced acute pancreatitis, but the difference was not statistically significant.


CONCLUSIONS
The results of this trial suggest that ulinastatin does not prevent hyperenzymemia following antegrade DBE.
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University Hospital, Kyushu University, Fukuoka, Japan.
Soichi
S
Itaba
Kazuhiko
K
Nakamura
Akira
A
Aso
Shoji
S
Tokunaga
Hirotada
H
Akiho
Eikichi
E
Ihara
Yoichiro
Y
Iboshi
Tsutomu
T
Iwasa
Kazuya
K
Akahoshi
Tetsuhide
T
Ito
Ryoichi
R
Takayanagi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000681:Amylases / Q000097:blood*; D004305:Dose-Response Relationship, Drug; D058582:Double-Balloon Enteroscopy / Q000009:adverse effects* / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006023:Glycoproteins / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007410:Intestinal Diseases / Q000175:diagnosis; D007421:Intestine, Small / Q000473:pathology; D008049:Lipase / Q000097:blood*; D008297:Male; D008875:Middle Aged; D019283:Pancreatitis, Acute Necrotizing / Q000201:enzymology / Q000209:etiology / Q000517:prevention & control*; D011379:Prognosis; D011446:Prospective Studies; D016896:Treatment Outcome; D014361:Trypsin Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D055815:Young Adult
D006023:Glycoproteins; D014361:Trypsin Inhibitors; D008049:Lipase; D000681:Amylases; C028665:urinastatin
double balloon endoscopy; hyperamylasemia; hyperenzymemia; hyperlipasemia; pancreatitis