Download PDF
Endoscopy 2015; 47(05): 415-420
DOI: 10.1055/s-0034-1391227
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Prophylactic somatostatin can reduce incidence of post-ERCP pancreatitis: multicenter randomized controlled trial

Yu Bai   *
1   Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China
,
Xu Ren   **
2   Department of Gastroenterology, Heilongjiang Province Hospital, Harbin, China
,
Xiao-Feng Zhang   *
3   Department of Gastroenterology, First People’s Hospital of Hangzhou, Hangzhou, Zhejiang, China
,
Nong-Hua Lv   **
4   Department of Gastroenterology, First Affiliated Hospital, Nan Chang University, Jiangxi, China
,
Xue-Gang Guo   *
5   Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi’an, China
,
Xin-Jian Wan
6   Department of Gastroenterology, First People’s Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
,
Zhan-Guo Nie
7   Department of Gastroenterology, Urumchi General Hospital, Lanzhou Command, PLA, China
,
Shu-Tang Han
8   Gastrointestinal Endoscopy Center, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu, China
,
Ping Bie
9   Department of Gastroenterology, Southwest Hospital, Third Military Medical University, Chongqing, China
,
De-An Tian
10   Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
,
Ming Ji
11   Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
,
Zhao-Shen Li   **
1   Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China
› Author Affiliations
Further Information

Publication History

submitted 18 June 2014

accepted after revision 27 October 2014

Publication Date:
15 January 2015 (online)

Also available at
    Permissions and Reprints

See also:

Commentaire du travail de Bai Y et al., pp. 415Endoscopy 2015; 47(05): 476-476
DOI: 10.1055/s-0035-1547040

See also:

Video Comment on Yu Bai et al., pages 415–420Endoscopy 2015; 47(05): v7-v7
DOI: 10.1055/s-0034-1392082

Background and study aim: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) remains the most common complication of ERCP. Somatostatin may inhibit pancreatic secretion and has been tested for PEP prophylaxis. However, the results of previous studies are inconsistent. The aim of the current study was to investigate whether somatostatin can reduce the incidence of PEP.

Patients and methods: The study was a multicenter, open-label, randomized controlled trial. A total of 908 patients with normal amylase levels who were undergoing ERCP were randomized to receive somatostatin 250 μg bolus injection before ERCP and 250 μg/hour intravenous infusion for 11 hours after ERCP (somatostatin group) or no somatostatin treatments (control group). The incidences of PEP and hyperamylasemia were compared in the two groups.

Results: The full analysis set included 900 patients (445 in the somatostatin group, 455 in the control group). PEP developed in 34 patients (7.5 %) in the control group (95 % confidence interval [CI] 5.4 % – 10.3 %) and in 18 patients (4.0 %) in the somatostatin group (95 %CI 2.6 % – 6.3 %; P = 0.03). Hyperamylasemia occurred in 46 patients (10.1 %) in the control group (95 %CI 7.7 % – 13.2 %) and in 27 patients (6.1 %) in the somatostatin group (95 %CI 4.2 % – 8.7 %; P = 0.03). No perforation or death occurred during the study.

Conclusions: This study showed that somatostatin was effective and safe for the prevention of PEP and hyperamylasemia in ERCP patients.

(ClinicalTrials.gov number, NCT01431781).

* These authors are joint first authors.


** These authors are joint corresponding authors.


 

  • References

  • 1 Anderson MA, Fisher L. ASGE Standards of Practice Committee et al. Complications of ERCP. Gastrointest Endosc 2012; 75: 467-473
    CrossrefPubMedGoogle Scholar
  • 2 Andriulli A, Loperfido S, Napolitano G et al. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol 2007; 102: 1781-1788
    CrossrefPubMedGoogle Scholar
  • 3 Wang P, Li ZS, Liu F et al. Risk factors for ERCP-related complications: a prospective multicenter study. Am J Gastroenterol 2009; 104: 31-40
    CrossrefPubMedGoogle Scholar
  • 4 Bai Y, Gao J, Zhang W et al. Meta-analysis: allopurinol in the prevention of postendoscopic retrograde cholangiopancreatography pancreatitis. Aliment Pharmacol Ther 2008; 28: 557-564
    CrossrefPubMedGoogle Scholar
  • 5 Bai Y, Gao J, Shi X et al. Prophylactic corticosteroids do not prevent post-ERCP pancreatitis: a meta-analysis of randomized controlled trials. Pancreatology 2008; 8: 504-509
    CrossrefPubMedGoogle Scholar
  • 6 Bai Y, Gao J, Zou DW et al. Prophylactic octreotide administration does not prevent post-endoscopic retrograde cholangiopancreatography pancreatitis: a meta-analysis of randomized controlled trials. Pancreas 2008; 37: 241-246
    CrossrefPubMedGoogle Scholar
  • 7 Elmunzer BJ, Scheiman JM, Lehman GA et al. A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med 2012; 366: 1414-1422
    CrossrefPubMedGoogle Scholar
  • 8 Choudhary A, Bechtold ML, Arif M et al. Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review. Gastrointest Endosc 2011; 73: 275-282
    CrossrefPubMedGoogle Scholar
  • 9 Freeman ML. Pancreatic stents for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Clin Gastroenterol Hepatol 2007; 5: 1354-1365
    CrossrefPubMedGoogle Scholar
  • 10 Bordas JM, Toledo-Pimentel V, Llach J et al. Effects of bolus somatostatin in preventing pancreatitis after endoscopic pancreatography: results of a randomized study. Gastrointest Endosc 1998; 47: 230-234
    CrossrefPubMedGoogle Scholar
  • 11 Lee KT, Lee DH, Yoo BM. The prophylactic effect of somatostatin on post-therapeutic endoscopic retrograde cholangiopancreatography pancreatitis: a randomized, multicenter controlled trial. Pancreas 2008; 37: 445-448
    CrossrefPubMedGoogle Scholar
  • 12 Andriulli A, Clemente R, Solmi L et al. Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial. Gastrointest Endosc 2002; 56: 488-495
    CrossrefPubMedGoogle Scholar
  • 13 Andriulli A, Solmi L, Loperfido S et al. Prophylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate. Clin Gastroenterol Hepatol 2004; 2: 713-718
    CrossrefPubMedGoogle Scholar
  • 14 Omata F, Deshpande G, Tokuda Y et al. Meta-analysis: somatostatin or its long-acting analogue, octreotide, for prophylaxis against post-ERCP pancreatitis. J Gastroenterol 2010; 45: 885-895
    CrossrefPubMedGoogle Scholar
  • 15 Andriulli A, Leandro G, Federici T et al. Prophylactic administration of somatostatin or gabexate does not prevent pancreatitis after ERCP: an updated meta-analysis. Gastrointest Endosc 2007; 65: 624-632
    CrossrefPubMedGoogle Scholar
  • 16 Cotton PB, Lehman G, Vennes J et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
    CrossrefPubMedGoogle Scholar
  • 17 Moffatt DC, Coté GA, Avula H et al. Risk factors for ERCP-related complications in patients with pancreas divisum: a retrospective study. Gastrointest Endosc 2011; 73: 963-970
    CrossrefPubMedGoogle Scholar
  • 18 Cotton PB, Garrow DA, Gallagher J et al. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc 2009; 70: 80-88
    CrossrefPubMedGoogle Scholar
  • 19 Poon RT, Yeung C, Lo CM et al. Prophylactic effect of somatostatin on post-ERCP pancreatitis: a randomized controlled trial. Gastrointest Endosc 1999; 49: 593-598
    CrossrefPubMedGoogle Scholar
  • 20 Poon RT, Yeung C, Liu CL et al. Intravenous bolus somatostatin after diagnostic cholangiopancreatography reduces the incidence of pancreatitis associated with therapeutic endoscopic retrograde cholangiopancreatography procedures: a randomised controlled trial. Gut 2003; 52: 1768-1773
    CrossrefPubMedGoogle Scholar
  • 21 Testoni PA, Bagnolo F, Andriulli A et al. Octreotide 24-h prophylaxis in patients at high risk for post-ERCP pancreatitis: results of a multicenter, randomized, controlled trial. Aliment Pharmacol Ther 2001; 15: 965-972
    CrossrefPubMedGoogle Scholar
  • 22 Rudin D, Kiss A, Wetz RV et al. Somatostatin and gabexate for post-endoscopic retrograde cholangiopancreatography pancreatitis prevention: meta-analysis of randomized placebo-controlled trials. J Gastroenterol Hepatol 2007; 22: 977-983
    CrossrefPubMedGoogle Scholar
  • 23 Arvanitidis D, Anagnostopoulos GK, Giannopoulos D et al. Can somatostatin prevent post-ERCP pancreatitis? Results of a randomized controlled trial. J Gastroenterol Hepatol 2004; 19: 278-282
    CrossrefPubMedGoogle Scholar
  • 24 Bordas JM, Toledo V, Mondelo F et al. Prevention of pancreatic reactions by bolus somatostatin administration in patients undergoing endoscopic retrograde cholangio-pancreatography and endoscopic sphincterotomy. Horm Res 1988; 29: 106-108
    CrossrefPubMedGoogle Scholar
  • 25 Testoni PA, Masci E, Bagnolo F et al. Endoscopic papillo-sphincterotomy: prevention of pancreatic reaction by somatostatin. Ital J Gastroenterol 1988; 20: 70-73
    PubMedGoogle Scholar
  • 26 Saari A, Kivilaakso E, Schroder T. The influence of somatostatin on pancreatic irritation after pancreatography. An experimental and clinical study. Surg Res Comm 1988; 24: 271-278
    PubMedGoogle Scholar
  • 27 Deschner K, Kalloo A, Collen M et al. Somatostatin: an evaluation of its utility as adjunctive medication for ERCP. Gastrointest Endosc 1989; 35: A149
    CrossrefPubMedGoogle Scholar
  • 28 Guelrud M, Mendoza S, Viera L et al. Somatostatin prevents acute pancreatitis after pancreatic duct sphincter hydrostatic balloon dilation in patients with idiopathic recurrent pancreatitis. Gastrointest Endosc 1991; 37: 44-47
    CrossrefPubMedGoogle Scholar
  • 29 Persson B, Slezak P, Efendic S et al. Can somatostatin prevent injection pancreatitis after ERCP?. Hepatogastroenterology 1992; 39: 259-261
    PubMedGoogle Scholar
  • 30 Chan HH, Lai KH, Lin CK et al. Effect of somatostatin in the prevention of pancreatic complications after endoscopic retrograde cholangiopancreatography. J Chin Med Assoc 2008; 71: 605-609
    CrossrefPubMedGoogle Scholar
  • 31 Wang ZK, Yang YS, Cai FC et al. Is prophylactic somatostatin effective to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis or hyperamylasemia? A randomized, placebo-controlled pilot trial. Chin Med J (Engl) 2013; 126: 2403-2408
    PubMedGoogle Scholar
  • 32 Benvenuti S, Zancanella L, Piazzi L et al. Prevention of post-ERCP pancreatitis with somatostatin versus gabexate mesilate: a randomized placebo-controlled multicenter study. Dig Liv Dis 2006; 38: S15
    PubMedGoogle Scholar
  • 33 Altman DG. How large a sample?. In: Gore SM, Altman DG, , eds. Statistics in Practice. London: British Medical Association; 1982
    Google Scholar