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Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial.
J Gastroenterol. 2012 Aug; 47(8):912-7.JG

Abstract

BACKGROUND

Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (specifically, 100 mg of diclofenac or indomethacin) have shown promising prophylactic activity in post-ERCP pancreatitis (PEP). However, the 100-mg dose is higher than that ordinarily used in Japan.

METHODS

We performed a prospective randomized controlled study to evaluate the efficacy of low-dose rectal diclofenac for the prevention of PEP. Patients who were scheduled to undergo ERCP were randomized to receive a saline infusion either with 50 mg of rectal diclofenac (diclofenac group) or without (control group) 30 min before ERCP. The dose of diclofenac was reduced to 25 mg in patients weighing <50 kg. The primary outcome measure was the occurrence of PEP.

RESULTS

Enrollment was terminated early because the planned interim analysis found a statistically significant intergroup difference in the occurrence of PEP. A total of 104 patients were eligible for this study; 51 patients received rectal diclofenac. Twelve patients (11.5%) developed PEP: 3.9% (2/51) in the diclofenac group and 18.9% (10/53) in the control group (p = 0.017). After ERCP, the incidence of hyperamylasemia was not significantly different between the two groups. Post-ERCP pain was significantly more frequent in the control group than in the diclofenac group (37.7 vs. 7.8%, respectively; p < 0.001). There were no adverse events related to diclofenac.

CONCLUSIONS

Low-dose rectal diclofenac can prevent PEP.

Authors+Show Affiliations

Department of Hepato-Biliary-Pancreatology, Saga Prefectural Hospital Koseikan, 1-12-9 Mizugae, Saga, 840-8571, Japan. ootsuka-t@koseikan.jpNo 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

22350703

Citation

Otsuka, Taiga, et al. "Low-dose Rectal Diclofenac for Prevention of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: a Randomized Controlled Trial." Journal of Gastroenterology, vol. 47, no. 8, 2012, pp. 912-7.
Otsuka T, Kawazoe S, Nakashita S, et al. Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial. J Gastroenterol. 2012;47(8):912-7.
Otsuka, T., Kawazoe, S., Nakashita, S., Kamachi, S., Oeda, S., Sumida, C., Akiyama, T., Ario, K., Fujimoto, M., Tabuchi, M., & Noda, T. (2012). Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial. Journal of Gastroenterology, 47(8), 912-7. https://doi.org/10.1007/s00535-012-0554-7
Otsuka T, et al. Low-dose Rectal Diclofenac for Prevention of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: a Randomized Controlled Trial. J Gastroenterol. 2012;47(8):912-7. PubMed PMID: 22350703.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial. AU - Otsuka,Taiga, AU - Kawazoe,Seiji, AU - Nakashita,Shunya, AU - Kamachi,Saori, AU - Oeda,Satoshi, AU - Sumida,Chinatsu, AU - Akiyama,Takumi, AU - Ario,Keisuke, AU - Fujimoto,Masaru, AU - Tabuchi,Masanobu, AU - Noda,Takahiro, Y1 - 2012/02/18/ PY - 2011/09/08/received PY - 2012/01/25/accepted PY - 2012/2/22/entrez PY - 2012/2/22/pubmed PY - 2013/1/17/medline SP - 912 EP - 7 JF - Journal of gastroenterology JO - J. Gastroenterol. VL - 47 IS - 8 N2 - BACKGROUND: Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Rectal nonsteroidal anti-inflammatory drugs (specifically, 100 mg of diclofenac or indomethacin) have shown promising prophylactic activity in post-ERCP pancreatitis (PEP). However, the 100-mg dose is higher than that ordinarily used in Japan. METHODS: We performed a prospective randomized controlled study to evaluate the efficacy of low-dose rectal diclofenac for the prevention of PEP. Patients who were scheduled to undergo ERCP were randomized to receive a saline infusion either with 50 mg of rectal diclofenac (diclofenac group) or without (control group) 30 min before ERCP. The dose of diclofenac was reduced to 25 mg in patients weighing <50 kg. The primary outcome measure was the occurrence of PEP. RESULTS: Enrollment was terminated early because the planned interim analysis found a statistically significant intergroup difference in the occurrence of PEP. A total of 104 patients were eligible for this study; 51 patients received rectal diclofenac. Twelve patients (11.5%) developed PEP: 3.9% (2/51) in the diclofenac group and 18.9% (10/53) in the control group (p = 0.017). After ERCP, the incidence of hyperamylasemia was not significantly different between the two groups. Post-ERCP pain was significantly more frequent in the control group than in the diclofenac group (37.7 vs. 7.8%, respectively; p < 0.001). There were no adverse events related to diclofenac. CONCLUSIONS: Low-dose rectal diclofenac can prevent PEP. SN - 1435-5922 UR - https://www.unboundmedicine.com/medline/citation/22350703/Low_dose_rectal_diclofenac_for_prevention_of_post_endoscopic_retrograde_cholangiopancreatography_pancreatitis:_a_randomized_controlled_trial_ L2 - https://dx.doi.org/10.1007/s00535-012-0554-7 DB - PRIME DP - Unbound Medicine ER -