Prospective, randomized, double-blind, placebo-controlled trial of ulinastatin for prevention of hyperenzymemia after double balloon endoscopy via the antegrade approach

Soichi Itaba, Kazuhiko Nakamura, Akira Aso, Shoji Tokunaga, Hirotada Akiho, Eikichi Ihara, Yoichiro Iboshi, Tsutomu Iwasa, Kazuya Akahoshi, Tetsuhide Ito, Ryoichi Takayanagi

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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. Patients and 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. Conclusion The results of this trial suggest that ulinastatin does not prevent hyperenzymemia following antegrade DBE.

Original languageEnglish
Pages (from-to)421-427
Number of pages7
JournalDigestive Endoscopy
Volume25
Issue number4
DOIs
Publication statusPublished - Jul 1 2013

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Endoscopy
Placebos
Pancreatitis
Endoscopes
Lipase
urinastatin
Endoscopic Retrograde Cholangiopancreatography
Sex Ratio
Amylases
Intravenous Infusions
Small Intestine
Serum

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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Prospective, randomized, double-blind, placebo-controlled trial of ulinastatin for prevention of hyperenzymemia after double balloon endoscopy via the antegrade approach. / Itaba, Soichi; Nakamura, Kazuhiko; Aso, Akira; Tokunaga, Shoji; Akiho, Hirotada; Ihara, Eikichi; Iboshi, Yoichiro; Iwasa, Tsutomu; Akahoshi, Kazuya; Ito, Tetsuhide; Takayanagi, Ryoichi.

In: Digestive Endoscopy, Vol. 25, No. 4, 01.07.2013, p. 421-427.

Research output: Contribution to journalArticle

Itaba, Soichi ; Nakamura, Kazuhiko ; Aso, Akira ; Tokunaga, Shoji ; Akiho, Hirotada ; Ihara, Eikichi ; Iboshi, Yoichiro ; Iwasa, Tsutomu ; Akahoshi, Kazuya ; Ito, Tetsuhide ; Takayanagi, Ryoichi. / Prospective, randomized, double-blind, placebo-controlled trial of ulinastatin for prevention of hyperenzymemia after double balloon endoscopy via the antegrade approach. In: Digestive Endoscopy. 2013 ; Vol. 25, No. 4. pp. 421-427.
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abstract = "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. Patients and 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. Conclusion The results of this trial suggest that ulinastatin does not prevent hyperenzymemia following antegrade DBE.",
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T1 - Prospective, randomized, double-blind, placebo-controlled trial of ulinastatin for prevention of hyperenzymemia after double balloon endoscopy via the antegrade approach

AU - Itaba, Soichi

AU - Nakamura, Kazuhiko

AU - Aso, Akira

AU - Tokunaga, Shoji

AU - Akiho, Hirotada

AU - Ihara, Eikichi

AU - Iboshi, Yoichiro

AU - Iwasa, Tsutomu

AU - Akahoshi, Kazuya

AU - Ito, Tetsuhide

AU - Takayanagi, Ryoichi

PY - 2013/7/1

Y1 - 2013/7/1

N2 - 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. Patients and 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. Conclusion The results of this trial suggest that ulinastatin does not prevent hyperenzymemia following antegrade DBE.

AB - 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. Patients and 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. Conclusion The results of this trial suggest that ulinastatin does not prevent hyperenzymemia following antegrade DBE.

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DO - 10.1111/den.12014

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C2 - 23368820

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VL - 25

SP - 421

EP - 427

JO - Digestive Endoscopy

JF - Digestive Endoscopy

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