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Effect of Somatostatin Plus Diclofenac in Comparison with Diclofenac Before ERCP on the Pancreatitis Double Blinded Randomized Clinical Trial

Received: 8 December 2022    Accepted: 16 February 2023    Published: 20 March 2023
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Abstract

Background/Aims: Despite many therapeutic attempts, post-retrograde cholangiopancreatography pancreatitis (PEP) has remained as a major challenge in interventional endoscopy. This study aimed to compare the effects of intravenous somatostatin plus rectal diclofenac with rectal diclofenac alone in the prevention of PEP. Methods: In a double-blind, randomized clinical trial, patients candidate for ERCP who accepted the study protocol were enrolled in the study between 2019 and 2021. The exclusion criteria include a history of pancreatobiliary surgery, ERCP, acute pancreatitis, contraindication, sensitivity to somatostatin, diclofenac, and pregnancy. PEP was defined as abdominal pain with elevated amylase level. Patients who received intravenous somatostatin plus diclofenac and diclofenac alone enrolled in case group and control group respectively. Patients were followed up for 24h after the procedure. Data regarding demographic, clinical presentation and laboratories results were recorded and compared. Results: A total 186 patients were enrolled, 91 in the case group and 95 as controls. There was no statistically significant difference between the two groups in terms of PEP incidence, complications or changes in serum amylase level (p > 0.05). Conclusion: Rectal diclofenac combined with intravenous somatostatin was superior to rectal diclofenac alone to prevent PE, but without a statistically significant difference, which is probably due to the synergic effect of somatostatin and diclofenac.

Published in International Journal of Gastroenterology (Volume 7, Issue 1)
DOI 10.11648/j.ijg.20230701.12
Page(s) 15-20
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2023. Published by Science Publishing Group

Keywords

Diclofenac, ERCP, Post-ERCP Pancreatitis, Somatostatin

References
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  • APA Style

    Homa Abri, Farhad Zamani, Mahsa Agahi, Hossein Ajdarkosh, Amirhossein Faraji, et al. (2023). Effect of Somatostatin Plus Diclofenac in Comparison with Diclofenac Before ERCP on the Pancreatitis Double Blinded Randomized Clinical Trial. International Journal of Gastroenterology, 7(1), 15-20. https://doi.org/10.11648/j.ijg.20230701.12

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    ACS Style

    Homa Abri; Farhad Zamani; Mahsa Agahi; Hossein Ajdarkosh; Amirhossein Faraji, et al. Effect of Somatostatin Plus Diclofenac in Comparison with Diclofenac Before ERCP on the Pancreatitis Double Blinded Randomized Clinical Trial. Int. J. Gastroenterol. 2023, 7(1), 15-20. doi: 10.11648/j.ijg.20230701.12

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    AMA Style

    Homa Abri, Farhad Zamani, Mahsa Agahi, Hossein Ajdarkosh, Amirhossein Faraji, et al. Effect of Somatostatin Plus Diclofenac in Comparison with Diclofenac Before ERCP on the Pancreatitis Double Blinded Randomized Clinical Trial. Int J Gastroenterol. 2023;7(1):15-20. doi: 10.11648/j.ijg.20230701.12

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  • @article{10.11648/j.ijg.20230701.12,
      author = {Homa Abri and Farhad Zamani and Mahsa Agahi and Hossein Ajdarkosh and Amirhossein Faraji and Mahmoodreza Khoonsari and Elham Sobhrakhshankhah and Nima Motamed and Masoudreza Sohrabi and Fahimeh Safarnezhad Tameshkel and Roghaye Sahraei and Pardis Sadeghipour and Mehdi Nikkhah},
      title = {Effect of Somatostatin Plus Diclofenac in Comparison with Diclofenac Before ERCP on the Pancreatitis Double Blinded Randomized Clinical Trial},
      journal = {International Journal of Gastroenterology},
      volume = {7},
      number = {1},
      pages = {15-20},
      doi = {10.11648/j.ijg.20230701.12},
      url = {https://doi.org/10.11648/j.ijg.20230701.12},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijg.20230701.12},
      abstract = {Background/Aims: Despite many therapeutic attempts, post-retrograde cholangiopancreatography pancreatitis (PEP) has remained as a major challenge in interventional endoscopy. This study aimed to compare the effects of intravenous somatostatin plus rectal diclofenac with rectal diclofenac alone in the prevention of PEP. Methods: In a double-blind, randomized clinical trial, patients candidate for ERCP who accepted the study protocol were enrolled in the study between 2019 and 2021. The exclusion criteria include a history of pancreatobiliary surgery, ERCP, acute pancreatitis, contraindication, sensitivity to somatostatin, diclofenac, and pregnancy. PEP was defined as abdominal pain with elevated amylase level. Patients who received intravenous somatostatin plus diclofenac and diclofenac alone enrolled in case group and control group respectively. Patients were followed up for 24h after the procedure. Data regarding demographic, clinical presentation and laboratories results were recorded and compared. Results: A total 186 patients were enrolled, 91 in the case group and 95 as controls. There was no statistically significant difference between the two groups in terms of PEP incidence, complications or changes in serum amylase level (p > 0.05). Conclusion: Rectal diclofenac combined with intravenous somatostatin was superior to rectal diclofenac alone to prevent PE, but without a statistically significant difference, which is probably due to the synergic effect of somatostatin and diclofenac.},
     year = {2023}
    }
    

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  • TY  - JOUR
    T1  - Effect of Somatostatin Plus Diclofenac in Comparison with Diclofenac Before ERCP on the Pancreatitis Double Blinded Randomized Clinical Trial
    AU  - Homa Abri
    AU  - Farhad Zamani
    AU  - Mahsa Agahi
    AU  - Hossein Ajdarkosh
    AU  - Amirhossein Faraji
    AU  - Mahmoodreza Khoonsari
    AU  - Elham Sobhrakhshankhah
    AU  - Nima Motamed
    AU  - Masoudreza Sohrabi
    AU  - Fahimeh Safarnezhad Tameshkel
    AU  - Roghaye Sahraei
    AU  - Pardis Sadeghipour
    AU  - Mehdi Nikkhah
    Y1  - 2023/03/20
    PY  - 2023
    N1  - https://doi.org/10.11648/j.ijg.20230701.12
    DO  - 10.11648/j.ijg.20230701.12
    T2  - International Journal of Gastroenterology
    JF  - International Journal of Gastroenterology
    JO  - International Journal of Gastroenterology
    SP  - 15
    EP  - 20
    PB  - Science Publishing Group
    SN  - 2640-169X
    UR  - https://doi.org/10.11648/j.ijg.20230701.12
    AB  - Background/Aims: Despite many therapeutic attempts, post-retrograde cholangiopancreatography pancreatitis (PEP) has remained as a major challenge in interventional endoscopy. This study aimed to compare the effects of intravenous somatostatin plus rectal diclofenac with rectal diclofenac alone in the prevention of PEP. Methods: In a double-blind, randomized clinical trial, patients candidate for ERCP who accepted the study protocol were enrolled in the study between 2019 and 2021. The exclusion criteria include a history of pancreatobiliary surgery, ERCP, acute pancreatitis, contraindication, sensitivity to somatostatin, diclofenac, and pregnancy. PEP was defined as abdominal pain with elevated amylase level. Patients who received intravenous somatostatin plus diclofenac and diclofenac alone enrolled in case group and control group respectively. Patients were followed up for 24h after the procedure. Data regarding demographic, clinical presentation and laboratories results were recorded and compared. Results: A total 186 patients were enrolled, 91 in the case group and 95 as controls. There was no statistically significant difference between the two groups in terms of PEP incidence, complications or changes in serum amylase level (p > 0.05). Conclusion: Rectal diclofenac combined with intravenous somatostatin was superior to rectal diclofenac alone to prevent PE, but without a statistically significant difference, which is probably due to the synergic effect of somatostatin and diclofenac.
    VL  - 7
    IS  - 1
    ER  - 

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Author Information
  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Department of Social Medicine, Zanjan University of Medical Science, Zanjan, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

  • Gastrointestinal and Liver Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran

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