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Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial.
Endoscopy 2012; 44(1):53-9E

Abstract

BACKGROUND AND STUDY AIMS

Pancreatitis is the most common complication of therapeutic endoscopic retrograde cholangiopancreatography (ERCP), and many pharmacoprophylactic approaches have been suggested, though not without controversy. The aim was to investigate the impact of combined therapy with diclofenac plus somatostatin on reducing the frequency and severity of post-ERCP pancreatitis (PEP).

PATIENTS AND METHODS

A prospective, double-blind, placebo-controlled trial was conducted in two tertiary referral centers, with 540 eligible patients randomized to receive either combined therapy with diclofenac 100 mg rectally 30 to 60 minutes before ERCP plus somatostatin 0.25 mg/h for 6 hours (group A), or a placebo suppository identical in appearance to the diclofenac along with saline solution (group B). Patients were clinically evaluated and serum amylase levels were determined before ERCP and at 6 and 24 hours post-procedure. Standardized criteria were used to diagnose and grade the severity of PEP. Adverse events were recorded prospectively.

RESULTS

There were no statistical differences between the groups regarding demographic data, ERCP findings, and procedure risk factors for PEP. The overall incidence of acute pancreatitis was 7.2 %. The PEP rate was significantly lower in the patients who received the combination therapy than in controls (4.7 % vs. 10.4 %, P = 0.015). Previous history of acute pancreatitis (P = 0.001), pancreatic opacification of first-class branches and beyond (P = 0.008), and absence of pharmacoprophylaxis (P = 0.023) were identified as independent risk factors for PEP in multivariate analysis.

CONCLUSION

Although combined prophylactic therapy with diclofenac plus somatostatin was promising in reducing frequency of PEP, further comparative large-scale studies are needed to confirm our findings before definitive conclusions can be drawn.

Authors+Show Affiliations

Department of Endoscopy and Motility Unit, G. Gennimatas General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. gchatzimav@yahoo.grNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22198776

Citation

Katsinelos, P, et al. "Combination of Diclofenac Plus Somatostatin in the Prevention of post-ERCP Pancreatitis: a Randomized, Double-blind, Placebo-controlled Trial." Endoscopy, vol. 44, no. 1, 2012, pp. 53-9.
Katsinelos P, Fasoulas K, Paroutoglou G, et al. Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial. Endoscopy. 2012;44(1):53-9.
Katsinelos, P., Fasoulas, K., Paroutoglou, G., Chatzimavroudis, G., Beltsis, A., Terzoudis, S., ... Kountouras, J. (2012). Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial. Endoscopy, 44(1), pp. 53-9. doi:10.1055/s-0031-1291440.
Katsinelos P, et al. Combination of Diclofenac Plus Somatostatin in the Prevention of post-ERCP Pancreatitis: a Randomized, Double-blind, Placebo-controlled Trial. Endoscopy. 2012;44(1):53-9. PubMed PMID: 22198776.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combination of diclofenac plus somatostatin in the prevention of post-ERCP pancreatitis: a randomized, double-blind, placebo-controlled trial. AU - Katsinelos,P, AU - Fasoulas,K, AU - Paroutoglou,G, AU - Chatzimavroudis,G, AU - Beltsis,A, AU - Terzoudis,S, AU - Katsinelos,T, AU - Dimou,E, AU - Zavos,C, AU - Kaltsa,A, AU - Kountouras,J, Y1 - 2011/12/23/ PY - 2011/12/27/entrez PY - 2011/12/27/pubmed PY - 2012/8/4/medline SP - 53 EP - 9 JF - Endoscopy JO - Endoscopy VL - 44 IS - 1 N2 - BACKGROUND AND STUDY AIMS: Pancreatitis is the most common complication of therapeutic endoscopic retrograde cholangiopancreatography (ERCP), and many pharmacoprophylactic approaches have been suggested, though not without controversy. The aim was to investigate the impact of combined therapy with diclofenac plus somatostatin on reducing the frequency and severity of post-ERCP pancreatitis (PEP). PATIENTS AND METHODS: A prospective, double-blind, placebo-controlled trial was conducted in two tertiary referral centers, with 540 eligible patients randomized to receive either combined therapy with diclofenac 100 mg rectally 30 to 60 minutes before ERCP plus somatostatin 0.25 mg/h for 6 hours (group A), or a placebo suppository identical in appearance to the diclofenac along with saline solution (group B). Patients were clinically evaluated and serum amylase levels were determined before ERCP and at 6 and 24 hours post-procedure. Standardized criteria were used to diagnose and grade the severity of PEP. Adverse events were recorded prospectively. RESULTS: There were no statistical differences between the groups regarding demographic data, ERCP findings, and procedure risk factors for PEP. The overall incidence of acute pancreatitis was 7.2 %. The PEP rate was significantly lower in the patients who received the combination therapy than in controls (4.7 % vs. 10.4 %, P = 0.015). Previous history of acute pancreatitis (P = 0.001), pancreatic opacification of first-class branches and beyond (P = 0.008), and absence of pharmacoprophylaxis (P = 0.023) were identified as independent risk factors for PEP in multivariate analysis. CONCLUSION: Although combined prophylactic therapy with diclofenac plus somatostatin was promising in reducing frequency of PEP, further comparative large-scale studies are needed to confirm our findings before definitive conclusions can be drawn. SN - 1438-8812 UR - https://www.unboundmedicine.com/medline/citation/22198776/Combination_of_diclofenac_plus_somatostatin_in_the_prevention_of_post_ERCP_pancreatitis:_a_randomized_double_blind_placebo_controlled_trial_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0031-1291440 DB - PRIME DP - Unbound Medicine ER -