Low‐dose rectal diclofenac does not prevent post‐ERCP pancreatitis in low‐ or high‐risk patients
Background and Aim The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post‐ERCP pancreatitis (PEP). Rectal nonsteroidal anti‐inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high‐risk patients. However,...
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Veröffentlicht in: | Journal of gastroenterology and hepatology 2020-07, Vol.35 (7), p.1247-1253 |
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creator | Katoh, Takao Kawashima, Kousaku Fukuba, Nobuhiko Masuda, Shigeto Kobatake, Hiroko Masaki, Kousaku Araki, Yasuhiro Kawano, Koichiro Nishi, Katsuhisa Takenaka, Mamoru Ishihara, Shunji Kinoshita, Yoshikazu |
description | Background and Aim
The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post‐ERCP pancreatitis (PEP). Rectal nonsteroidal anti‐inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high‐risk patients. However, in contrast to high‐risk patients, the role of NSAID administration in patients with low risk remains controversial.
Methods
We performed a prospective, single‐center, single‐blinded, two‐arm parallel group, randomized controlled trial to clarify the efficacy of low dose (50 mg) rectal NSAID administration for preventing PEP in at‐risk patients. Patients scheduled to undergo ERCP were randomized into two groups, those with and without rectal administration of diclofenac. Patients in the diclofenac group received 50 mg of rectal diclofenac 30 min before undergoing ERCP. The primary endpoint was rate of PEP.
Results
A total of 303 were randomized into the study groups. Four patients declined participation following randomization, and another two were withdrawn. As a result, a total of 147 patients were assigned to the diclofenac group and 150 to the control group. The baseline and procedural characteristics were similar in both groups. The primary endpoint of PEP occurrence was seen in 13 of 297 patients (4.4%), including eight (5.4%) in the diclofenac group and five (3.3%) in the control group (P = 0.286). Additionally, those results were not significantly different when patients were classified as low or high risk.
Conclusions
Prophylactic low‐dose rectal diclofenac did not reduce the incidence of PEP following ERCP in patients classified as low or high risk. |
doi_str_mv | 10.1111/jgh.14948 |
format | Article |
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The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post‐ERCP pancreatitis (PEP). Rectal nonsteroidal anti‐inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high‐risk patients. However, in contrast to high‐risk patients, the role of NSAID administration in patients with low risk remains controversial.
Methods
We performed a prospective, single‐center, single‐blinded, two‐arm parallel group, randomized controlled trial to clarify the efficacy of low dose (50 mg) rectal NSAID administration for preventing PEP in at‐risk patients. Patients scheduled to undergo ERCP were randomized into two groups, those with and without rectal administration of diclofenac. Patients in the diclofenac group received 50 mg of rectal diclofenac 30 min before undergoing ERCP. The primary endpoint was rate of PEP.
Results
A total of 303 were randomized into the study groups. Four patients declined participation following randomization, and another two were withdrawn. As a result, a total of 147 patients were assigned to the diclofenac group and 150 to the control group. The baseline and procedural characteristics were similar in both groups. The primary endpoint of PEP occurrence was seen in 13 of 297 patients (4.4%), including eight (5.4%) in the diclofenac group and five (3.3%) in the control group (P = 0.286). Additionally, those results were not significantly different when patients were classified as low or high risk.
Conclusions
Prophylactic low‐dose rectal diclofenac did not reduce the incidence of PEP following ERCP in patients classified as low or high risk.</description><identifier>ISSN: 0815-9319</identifier><identifier>EISSN: 1440-1746</identifier><identifier>DOI: 10.1111/jgh.14948</identifier><identifier>PMID: 31788849</identifier><language>eng</language><publisher>Australia: Wiley Subscription Services, Inc</publisher><subject>Diclofenac ; ERCP ; Inflammation ; Nonsteroidal anti-inflammatory drugs ; Pancreatitis ; post‐ERCP pancreatitis ; Rectum</subject><ispartof>Journal of gastroenterology and hepatology, 2020-07, Vol.35 (7), p.1247-1253</ispartof><rights>2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd</rights><rights>2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.</rights><rights>2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3978-144e37a53ae0e7a7e6384e2b31457b48b695a9f3ec114fdec414ea6c9d957e693</citedby><cites>FETCH-LOGICAL-c3978-144e37a53ae0e7a7e6384e2b31457b48b695a9f3ec114fdec414ea6c9d957e693</cites><orcidid>0000-0002-5815-0066 ; 0000-0002-6288-0045</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjgh.14948$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjgh.14948$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,777,781,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31788849$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Katoh, Takao</creatorcontrib><creatorcontrib>Kawashima, Kousaku</creatorcontrib><creatorcontrib>Fukuba, Nobuhiko</creatorcontrib><creatorcontrib>Masuda, Shigeto</creatorcontrib><creatorcontrib>Kobatake, Hiroko</creatorcontrib><creatorcontrib>Masaki, Kousaku</creatorcontrib><creatorcontrib>Araki, Yasuhiro</creatorcontrib><creatorcontrib>Kawano, Koichiro</creatorcontrib><creatorcontrib>Nishi, Katsuhisa</creatorcontrib><creatorcontrib>Takenaka, Mamoru</creatorcontrib><creatorcontrib>Ishihara, Shunji</creatorcontrib><creatorcontrib>Kinoshita, Yoshikazu</creatorcontrib><title>Low‐dose rectal diclofenac does not prevent post‐ERCP pancreatitis in low‐ or high‐risk patients</title><title>Journal of gastroenterology and hepatology</title><addtitle>J Gastroenterol Hepatol</addtitle><description>Background and Aim
The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post‐ERCP pancreatitis (PEP). Rectal nonsteroidal anti‐inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high‐risk patients. However, in contrast to high‐risk patients, the role of NSAID administration in patients with low risk remains controversial.
Methods
We performed a prospective, single‐center, single‐blinded, two‐arm parallel group, randomized controlled trial to clarify the efficacy of low dose (50 mg) rectal NSAID administration for preventing PEP in at‐risk patients. Patients scheduled to undergo ERCP were randomized into two groups, those with and without rectal administration of diclofenac. Patients in the diclofenac group received 50 mg of rectal diclofenac 30 min before undergoing ERCP. The primary endpoint was rate of PEP.
Results
A total of 303 were randomized into the study groups. Four patients declined participation following randomization, and another two were withdrawn. As a result, a total of 147 patients were assigned to the diclofenac group and 150 to the control group. The baseline and procedural characteristics were similar in both groups. The primary endpoint of PEP occurrence was seen in 13 of 297 patients (4.4%), including eight (5.4%) in the diclofenac group and five (3.3%) in the control group (P = 0.286). Additionally, those results were not significantly different when patients were classified as low or high risk.
Conclusions
Prophylactic low‐dose rectal diclofenac did not reduce the incidence of PEP following ERCP in patients classified as low or high risk.</description><subject>Diclofenac</subject><subject>ERCP</subject><subject>Inflammation</subject><subject>Nonsteroidal anti-inflammatory drugs</subject><subject>Pancreatitis</subject><subject>post‐ERCP pancreatitis</subject><subject>Rectum</subject><issn>0815-9319</issn><issn>1440-1746</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp10MFOGzEQBmALFTVp2gMvgCz10h4W7PXsen2sopSAIlFV7dlyvLOJw2Yd7A1RbjwCz8iTYAhwqFRfxodvfo1-Qk44O-Ppna8WyzMOCqojMuQALOMSyg9kyCpeZEpwNSCfYlwxxoDJ4iMZCC6rqgI1JMuZ3z3eP9Q-Ig1oe9PS2tnWN9gZS2uPkXa-p5uAd9il6WOf-OT3-BfdmM4GNL3rXaSuo-1LEvWBLt1imb7BxZukepc242dy3Jg24pfXOSJ_f07-jKfZ7PricvxjllmhZJWl81FIUwiDDKWRWIoKMJ8LDoWcQzUvVWFUI9ByDk2NFjigKa2qVZGwEiPy7ZC7Cf52i7HXaxcttq3p0G-jzkXOSmAgRaJf_6Ervw1duk7nkHPJVC4hqe8HZYOPMWCjN8GtTdhrzvRz_TrVr1_qT_b0NXE7X2P9Lt_6TuD8AHauxf3_k_TVxfQQ-QT8pJJC</recordid><startdate>202007</startdate><enddate>202007</enddate><creator>Katoh, Takao</creator><creator>Kawashima, Kousaku</creator><creator>Fukuba, Nobuhiko</creator><creator>Masuda, Shigeto</creator><creator>Kobatake, Hiroko</creator><creator>Masaki, Kousaku</creator><creator>Araki, Yasuhiro</creator><creator>Kawano, Koichiro</creator><creator>Nishi, Katsuhisa</creator><creator>Takenaka, Mamoru</creator><creator>Ishihara, Shunji</creator><creator>Kinoshita, Yoshikazu</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-5815-0066</orcidid><orcidid>https://orcid.org/0000-0002-6288-0045</orcidid></search><sort><creationdate>202007</creationdate><title>Low‐dose rectal diclofenac does not prevent post‐ERCP pancreatitis in low‐ or high‐risk patients</title><author>Katoh, Takao ; Kawashima, Kousaku ; Fukuba, Nobuhiko ; Masuda, Shigeto ; Kobatake, Hiroko ; Masaki, Kousaku ; Araki, Yasuhiro ; Kawano, Koichiro ; Nishi, Katsuhisa ; Takenaka, Mamoru ; Ishihara, Shunji ; Kinoshita, Yoshikazu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3978-144e37a53ae0e7a7e6384e2b31457b48b695a9f3ec114fdec414ea6c9d957e693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Diclofenac</topic><topic>ERCP</topic><topic>Inflammation</topic><topic>Nonsteroidal anti-inflammatory drugs</topic><topic>Pancreatitis</topic><topic>post‐ERCP pancreatitis</topic><topic>Rectum</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Katoh, Takao</creatorcontrib><creatorcontrib>Kawashima, Kousaku</creatorcontrib><creatorcontrib>Fukuba, Nobuhiko</creatorcontrib><creatorcontrib>Masuda, Shigeto</creatorcontrib><creatorcontrib>Kobatake, Hiroko</creatorcontrib><creatorcontrib>Masaki, Kousaku</creatorcontrib><creatorcontrib>Araki, Yasuhiro</creatorcontrib><creatorcontrib>Kawano, Koichiro</creatorcontrib><creatorcontrib>Nishi, Katsuhisa</creatorcontrib><creatorcontrib>Takenaka, Mamoru</creatorcontrib><creatorcontrib>Ishihara, Shunji</creatorcontrib><creatorcontrib>Kinoshita, Yoshikazu</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of gastroenterology and hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Katoh, Takao</au><au>Kawashima, Kousaku</au><au>Fukuba, Nobuhiko</au><au>Masuda, Shigeto</au><au>Kobatake, Hiroko</au><au>Masaki, Kousaku</au><au>Araki, Yasuhiro</au><au>Kawano, Koichiro</au><au>Nishi, Katsuhisa</au><au>Takenaka, Mamoru</au><au>Ishihara, Shunji</au><au>Kinoshita, Yoshikazu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Low‐dose rectal diclofenac does not prevent post‐ERCP pancreatitis in low‐ or high‐risk patients</atitle><jtitle>Journal of gastroenterology and hepatology</jtitle><addtitle>J Gastroenterol Hepatol</addtitle><date>2020-07</date><risdate>2020</risdate><volume>35</volume><issue>7</issue><spage>1247</spage><epage>1253</epage><pages>1247-1253</pages><issn>0815-9319</issn><eissn>1440-1746</eissn><abstract>Background and Aim
The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post‐ERCP pancreatitis (PEP). Rectal nonsteroidal anti‐inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high‐risk patients. However, in contrast to high‐risk patients, the role of NSAID administration in patients with low risk remains controversial.
Methods
We performed a prospective, single‐center, single‐blinded, two‐arm parallel group, randomized controlled trial to clarify the efficacy of low dose (50 mg) rectal NSAID administration for preventing PEP in at‐risk patients. Patients scheduled to undergo ERCP were randomized into two groups, those with and without rectal administration of diclofenac. Patients in the diclofenac group received 50 mg of rectal diclofenac 30 min before undergoing ERCP. The primary endpoint was rate of PEP.
Results
A total of 303 were randomized into the study groups. Four patients declined participation following randomization, and another two were withdrawn. As a result, a total of 147 patients were assigned to the diclofenac group and 150 to the control group. The baseline and procedural characteristics were similar in both groups. The primary endpoint of PEP occurrence was seen in 13 of 297 patients (4.4%), including eight (5.4%) in the diclofenac group and five (3.3%) in the control group (P = 0.286). Additionally, those results were not significantly different when patients were classified as low or high risk.
Conclusions
Prophylactic low‐dose rectal diclofenac did not reduce the incidence of PEP following ERCP in patients classified as low or high risk.</abstract><cop>Australia</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31788849</pmid><doi>10.1111/jgh.14948</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-5815-0066</orcidid><orcidid>https://orcid.org/0000-0002-6288-0045</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Diclofenac ERCP Inflammation Nonsteroidal anti-inflammatory drugs Pancreatitis post‐ERCP pancreatitis Rectum |
title | Low‐dose rectal diclofenac does not prevent post‐ERCP pancreatitis in low‐ or high‐risk patients |
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