| Peer-Reviewed

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
Views:       Downloads:
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
[1] Dumonceau JM, Andriulli A, Deviere J, Mariani A, Rigaux J, Baron TH, et al. European Society of Gastrointestinal Endoscopy (ESGE) Guideline: Prophylaxis of post-ERCP pancreatitis. Endoscopy 2010; 42. https://doi.org/10.1055/s-0029-1244208.
[2] Masci E, Toti G, Mariani A, Curioni S, Lomazzi A, Dinelli M, et al. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol 2001; 96: 417–23.
[3] Christensen M, Matzen P, Schulze S, Rosenberg J. Complications of ERCP: a prospective study. Gastrointest Endosc 2004; 60: 721–31.
[4] Vandervoort J, Soetikno RM, Tham TCK, Wong RCK, Ferrari Jr AP, Montes H, et al. Risk factors for complications after performance of ERCP. Gastrointest Endosc 2002; 56: 652–6.
[5] Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, et al. Risk factors for post-ercp pancreatitis: A prospective, multicenter study. Gastrointest Endosc 2001; 54. https://doi.org/10.1067/mge.2001.117550.
[6] Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc 2004; 59: 845–64.
[7] Arata S, Takada T, Hirata K, Yoshida M, Mayumi T, Hirota M, et al. Post-ERCP pancreatitis. J Hepatobiliary Pancreat Sci 2010; 17: 70–8.
[8] Rainio M, Lindström O, Udd M, Louhimo J, Kylänpää L. Diclofenac does not reduce the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis in low-risk units. J Gastrointest Surg 2017; 21: 1270–7.
[9] Otsuka T, Kawazoe S, Nakashita S, Kamachi S, Oeda S, Sumida C, et al. Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A randomized controlled trial. J Gastroenterol 2012. https://doi.org/10.1007/s00535-012-0554-7.
[10] Li T, D’Cruz RT, Lim SY, Shelat VG. Somatostatin analogues and the risk of post-operative pancreatic fistulas after pancreatic resection-A systematic review & meta-analysis. Pancreatology 2020; 20: 158–68.
[11] Zhao L-N, Yu T, Li C-Q, Lai Y, Chen Q-K. Somatostatin administration prior to ERCP is effective in reducing the risk of post-ERCP pancreatitis in high-risk patients. Exp Ther Med 2014; 8: 509–14.
[12] Wang G, Xiao G, Xu L, Qiu P, Li T, Wang X, et al. Effect of somatostatin on prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis and hyperamylasemia: A systematic review and meta-analysis. Pancreatology 2018; 18. https://doi.org/10.1016/j.pan.2018.03.002.
[13] Arvanitidis D, Anagnostopoulos GK, Giannopoulos D, Pantes A, Agaritsi R, Margantinis G, et al. Can somatostatin prevent post-ERCP pancreatitis? Results of a randomized controlled trial. J Gastroenterol Hepatol 2004; 19. https://doi.org/10.1111/j.1440-1746.2003.03297.x.
[14] Ding X, Zhang F, Wang Y. Risk factors for post-ERCP pancreatitis: A systematic review and meta-analysis. Surg 2015; 13: 218–29.
[15] Ahmed M, Alsaid A. Is combined inner preputial inlay graft with tubularized incised plate in hypospadias repair worth doing? J Pediatr Urol 2015; 11: 229-e1.
[16] Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, et al. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc 2015; 81: 143–9.
[17] Bai Y, Ren X, Zhang X-F, Lv N-H, Guo X-G, Wan X-J, et al. Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial. Endoscopy 2015; 47: 415–20.
[18] Senol A, Saritas U, Demirkan H. Efficacy of intramuscular diclofenac and fluid replacement in prevention of post-ERCP pancreatitis. World J Gastroenterol 2009; 15. https://doi.org/10.3748/wjg.15.3999.
[19] Cheon YK, Cho KB, Watkins JL, McHenry L, Fogel EL, Sherman S, et al. Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients: a randomized double-blind prospective trial. Gastrointest Endosc 2007; 66: 1126–32.
[20] Patai Á, Solymosi N, Mohácsi L, Patai Á V. Indomethacin and diclofenac in the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis of prospective controlled trials. Gastrointest Endosc 2017; 85: 1144–56.
[21] Geng C, Li X, Li Y, Song S, Wang C. Nonsteroidal anti-inflammatory drugs alleviate severity of post-endoscopic retrograde cholangiopancreatography pancreatitis by inhibiting inflammation and reducing apoptosis. J Gastroenterol Hepatol 2020; 35: 896–904.
[22] Khoshbaten M, Khorram H, Madad L, Ehsani Ardakani MJ, Farzin H, Zali MR. Role of diclofenac in reducing post-endoscopic retrograde cholangiopancreatography pancreatitis. J Gastroenterol Hepatol 2008; 23. https://doi.org/10.1111/j.1440-1746.2007.05096.x.
[23] Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc 2012; 76: 1152–9.
[24] Katsinelos P, Fasoulas K, Paroutoglou G, Chatzimavroudis G, Beltsis A, Terzoudis S, et al. Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial. Endoscopy 2012; 44: 53–9.
[25] Elbaih AH, Mohammed ME, Abdo MM, Ali K. Efficacy of Diclofenac Sodium Versus Somatostatin For The Prevention of Pancreatitis In Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Natl J Med Res n.d.: 259.
Cite This Article
  • 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

    Copy | Download

    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

    Copy | Download

    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

    Copy | Download

  • @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}
    }
    

    Copy | Download

  • 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  - 

    Copy | Download

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

  • Sections