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

研究成果: ジャーナルへの寄稿記事

6 引用 (Scopus)

抄録

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.

元の言語英語
ページ(範囲)421-427
ページ数7
ジャーナルDigestive Endoscopy
25
発行部数4
DOI
出版物ステータス出版済み - 7 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

これを引用

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.

:: Digestive Endoscopy, 巻 25, 番号 4, 01.07.2013, p. 421-427.

研究成果: ジャーナルへの寄稿記事

Itaba, S, Nakamura, K, Aso, A, Tokunaga, S, Akiho, H, Ihara, E, Iboshi, Y, Iwasa, T, Akahoshi, K, Ito, T & Takayanagi, R 2013, 'Prospective, randomized, double-blind, placebo-controlled trial of ulinastatin for prevention of hyperenzymemia after double balloon endoscopy via the antegrade approach', Digestive Endoscopy, 巻. 25, 番号 4, pp. 421-427. https://doi.org/10.1111/den.12014
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. :: Digestive Endoscopy. 2013 ; 巻 25, 番号 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.",
author = "Soichi Itaba and Kazuhiko Nakamura and Akira Aso and Shoji Tokunaga and Hirotada Akiho and Eikichi Ihara and Yoichiro Iboshi and Tsutomu Iwasa and Kazuya Akahoshi and Tetsuhide Ito and Ryoichi Takayanagi",
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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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U2 - 10.1111/den.12014

DO - 10.1111/den.12014

M3 - Article

C2 - 23368820

AN - SCOPUS:84879696307

VL - 25

SP - 421

EP - 427

JO - Digestive Endoscopy

JF - Digestive Endoscopy

SN - 0915-5635

IS - 4

ER -