Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial
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 1...
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| Veröffentlicht in: | Journal of gastroenterology 2012-08, Vol.47 (8), p.912-917 |
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| creator | Otsuka, Taiga Kawazoe, Seiji Nakashita, Shunya Kamachi, Saori Oeda, Satoshi Sumida, Chinatsu Akiyama, Takumi Ario, Keisuke Fujimoto, Masaru Tabuchi, Masanobu Noda, Takahiro |
| description | 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 |
| doi_str_mv | 10.1007/s00535-012-0554-7 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_1034659015</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A714586021</galeid><sourcerecordid>A714586021</sourcerecordid><originalsourceid>FETCH-LOGICAL-c518t-57d7f5423d8aebbef7bd51910ddc1fee8208103245cbc186b4e915cca1cea56a3</originalsourceid><addsrcrecordid>eNp1ks-OFCEQxjtG486uPoAXQ-LFS68UDU2Pt81GXZNJvOiZ0FDMsumGFhjN-gw-tHRm13_RcACK31dUwdc0z4CeA6XyVaZUdKKlwFoqBG_lg2YDvEbElrGHzYZuOW8BJD9pTnO-oRQ6KobHzQljnaCSdpvm-y5-bW3MSBKaoidivZmiw6ANcTGRJeEXDMXHQKIjS8ylxVB5ExdvqqakuE_aIjHXcdJh7-Oig0moyxpfrm_J_d4Xn18TTZKu-tl_Q0tMDFU_TXVZktfTk-aR01PGp3fzWfPp7ZuPl1ft7sO795cXu9YIGEorpJVOcNbZQeM4opOjFbAFaq0BhzgwOgDtGBdmNDD0I8ctCGM0GNSi191Z8_KYd0nx8wFzUbPPBqfaAMZDVlXMe7GlICr64i_0Jh5SqNWtlGSSc-h_UXs9ofLBxZK0WZOqCwlcDD1lUKnzf1B1WJx9fQt0vsb_EMBRYFLMOaFTS_KzTrf1brU6QB0doKoD1OoAJavm-V3Bh3FG-1Nx_-UVYEcg16Owx_R7R__L-gPMwr2f</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1037274416</pqid></control><display><type>article</type><title>Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial</title><source>MEDLINE</source><source>SpringerLink_现刊</source><creator>Otsuka, Taiga ; Kawazoe, Seiji ; Nakashita, Shunya ; Kamachi, Saori ; Oeda, Satoshi ; Sumida, Chinatsu ; Akiyama, Takumi ; Ario, Keisuke ; Fujimoto, Masaru ; Tabuchi, Masanobu ; Noda, Takahiro</creator><creatorcontrib>Otsuka, Taiga ; Kawazoe, Seiji ; Nakashita, Shunya ; Kamachi, Saori ; Oeda, Satoshi ; Sumida, Chinatsu ; Akiyama, Takumi ; Ario, Keisuke ; Fujimoto, Masaru ; Tabuchi, Masanobu ; Noda, Takahiro</creatorcontrib><description>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.</description><identifier>ISSN: 0944-1174</identifier><identifier>EISSN: 1435-5922</identifier><identifier>DOI: 10.1007/s00535-012-0554-7</identifier><identifier>PMID: 22350703</identifier><language>eng</language><publisher>Japan: Springer Japan</publisher><subject>Abdominal Surgery ; Aged ; Analysis ; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage ; Biliary Tract ; Cholangiopancreatography, Endoscopic Retrograde ; Clinical trials ; Colorectal Surgery ; Diclofenac - administration & dosage ; Dosage and administration ; Endoscopic retrograde cholangiopancreatography ; Female ; Gastroenterology ; Hepatology ; Humans ; Incidence ; Indomethacin ; Male ; Medical research ; Medicine ; Medicine & Public Health ; Medicine, Experimental ; Original Article—Liver ; Pancreas ; Pancreatitis ; Pancreatitis - etiology ; Pancreatitis - prevention & control ; Postoperative Complications ; Prevention ; Prospective Studies ; Surgical Oncology ; Treatment Outcome</subject><ispartof>Journal of gastroenterology, 2012-08, Vol.47 (8), p.912-917</ispartof><rights>Springer 2012</rights><rights>COPYRIGHT 2012 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c518t-57d7f5423d8aebbef7bd51910ddc1fee8208103245cbc186b4e915cca1cea56a3</citedby><cites>FETCH-LOGICAL-c518t-57d7f5423d8aebbef7bd51910ddc1fee8208103245cbc186b4e915cca1cea56a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00535-012-0554-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00535-012-0554-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22350703$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Otsuka, Taiga</creatorcontrib><creatorcontrib>Kawazoe, Seiji</creatorcontrib><creatorcontrib>Nakashita, Shunya</creatorcontrib><creatorcontrib>Kamachi, Saori</creatorcontrib><creatorcontrib>Oeda, Satoshi</creatorcontrib><creatorcontrib>Sumida, Chinatsu</creatorcontrib><creatorcontrib>Akiyama, Takumi</creatorcontrib><creatorcontrib>Ario, Keisuke</creatorcontrib><creatorcontrib>Fujimoto, Masaru</creatorcontrib><creatorcontrib>Tabuchi, Masanobu</creatorcontrib><creatorcontrib>Noda, Takahiro</creatorcontrib><title>Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial</title><title>Journal of gastroenterology</title><addtitle>J Gastroenterol</addtitle><addtitle>J Gastroenterol</addtitle><description>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.</description><subject>Abdominal Surgery</subject><subject>Aged</subject><subject>Analysis</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</subject><subject>Biliary Tract</subject><subject>Cholangiopancreatography, Endoscopic Retrograde</subject><subject>Clinical trials</subject><subject>Colorectal Surgery</subject><subject>Diclofenac - administration & dosage</subject><subject>Dosage and administration</subject><subject>Endoscopic retrograde cholangiopancreatography</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Incidence</subject><subject>Indomethacin</subject><subject>Male</subject><subject>Medical research</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Medicine, Experimental</subject><subject>Original Article—Liver</subject><subject>Pancreas</subject><subject>Pancreatitis</subject><subject>Pancreatitis - etiology</subject><subject>Pancreatitis - prevention & control</subject><subject>Postoperative Complications</subject><subject>Prevention</subject><subject>Prospective Studies</subject><subject>Surgical Oncology</subject><subject>Treatment Outcome</subject><issn>0944-1174</issn><issn>1435-5922</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1ks-OFCEQxjtG486uPoAXQ-LFS68UDU2Pt81GXZNJvOiZ0FDMsumGFhjN-gw-tHRm13_RcACK31dUwdc0z4CeA6XyVaZUdKKlwFoqBG_lg2YDvEbElrGHzYZuOW8BJD9pTnO-oRQ6KobHzQljnaCSdpvm-y5-bW3MSBKaoidivZmiw6ANcTGRJeEXDMXHQKIjS8ylxVB5ExdvqqakuE_aIjHXcdJh7-Oig0moyxpfrm_J_d4Xn18TTZKu-tl_Q0tMDFU_TXVZktfTk-aR01PGp3fzWfPp7ZuPl1ft7sO795cXu9YIGEorpJVOcNbZQeM4opOjFbAFaq0BhzgwOgDtGBdmNDD0I8ctCGM0GNSi191Z8_KYd0nx8wFzUbPPBqfaAMZDVlXMe7GlICr64i_0Jh5SqNWtlGSSc-h_UXs9ofLBxZK0WZOqCwlcDD1lUKnzf1B1WJx9fQt0vsb_EMBRYFLMOaFTS_KzTrf1brU6QB0doKoD1OoAJavm-V3Bh3FG-1Nx_-UVYEcg16Owx_R7R__L-gPMwr2f</recordid><startdate>20120801</startdate><enddate>20120801</enddate><creator>Otsuka, Taiga</creator><creator>Kawazoe, Seiji</creator><creator>Nakashita, Shunya</creator><creator>Kamachi, Saori</creator><creator>Oeda, Satoshi</creator><creator>Sumida, Chinatsu</creator><creator>Akiyama, Takumi</creator><creator>Ario, Keisuke</creator><creator>Fujimoto, Masaru</creator><creator>Tabuchi, Masanobu</creator><creator>Noda, Takahiro</creator><general>Springer Japan</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20120801</creationdate><title>Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial</title><author>Otsuka, Taiga ; Kawazoe, Seiji ; Nakashita, Shunya ; Kamachi, Saori ; Oeda, Satoshi ; Sumida, Chinatsu ; Akiyama, Takumi ; Ario, Keisuke ; Fujimoto, Masaru ; Tabuchi, Masanobu ; Noda, Takahiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c518t-57d7f5423d8aebbef7bd51910ddc1fee8208103245cbc186b4e915cca1cea56a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Abdominal Surgery</topic><topic>Aged</topic><topic>Analysis</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</topic><topic>Biliary Tract</topic><topic>Cholangiopancreatography, Endoscopic Retrograde</topic><topic>Clinical trials</topic><topic>Colorectal Surgery</topic><topic>Diclofenac - administration & dosage</topic><topic>Dosage and administration</topic><topic>Endoscopic retrograde cholangiopancreatography</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Hepatology</topic><topic>Humans</topic><topic>Incidence</topic><topic>Indomethacin</topic><topic>Male</topic><topic>Medical research</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Medicine, Experimental</topic><topic>Original Article—Liver</topic><topic>Pancreas</topic><topic>Pancreatitis</topic><topic>Pancreatitis - etiology</topic><topic>Pancreatitis - prevention & control</topic><topic>Postoperative Complications</topic><topic>Prevention</topic><topic>Prospective Studies</topic><topic>Surgical Oncology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Otsuka, Taiga</creatorcontrib><creatorcontrib>Kawazoe, Seiji</creatorcontrib><creatorcontrib>Nakashita, Shunya</creatorcontrib><creatorcontrib>Kamachi, Saori</creatorcontrib><creatorcontrib>Oeda, Satoshi</creatorcontrib><creatorcontrib>Sumida, Chinatsu</creatorcontrib><creatorcontrib>Akiyama, Takumi</creatorcontrib><creatorcontrib>Ario, Keisuke</creatorcontrib><creatorcontrib>Fujimoto, Masaru</creatorcontrib><creatorcontrib>Tabuchi, Masanobu</creatorcontrib><creatorcontrib>Noda, Takahiro</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>ProQuest_Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of gastroenterology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Otsuka, Taiga</au><au>Kawazoe, Seiji</au><au>Nakashita, Shunya</au><au>Kamachi, Saori</au><au>Oeda, Satoshi</au><au>Sumida, Chinatsu</au><au>Akiyama, Takumi</au><au>Ario, Keisuke</au><au>Fujimoto, Masaru</au><au>Tabuchi, Masanobu</au><au>Noda, Takahiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial</atitle><jtitle>Journal of gastroenterology</jtitle><stitle>J Gastroenterol</stitle><addtitle>J Gastroenterol</addtitle><date>2012-08-01</date><risdate>2012</risdate><volume>47</volume><issue>8</issue><spage>912</spage><epage>917</epage><pages>912-917</pages><issn>0944-1174</issn><eissn>1435-5922</eissn><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.</abstract><cop>Japan</cop><pub>Springer Japan</pub><pmid>22350703</pmid><doi>10.1007/s00535-012-0554-7</doi><tpages>6</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0944-1174 |
| ispartof | Journal of gastroenterology, 2012-08, Vol.47 (8), p.912-917 |
| issn | 0944-1174 1435-5922 |
| language | eng |
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| source | MEDLINE; SpringerLink_现刊 |
| subjects | Abdominal Surgery Aged Analysis Anti-Inflammatory Agents, Non-Steroidal - administration & dosage Biliary Tract Cholangiopancreatography, Endoscopic Retrograde Clinical trials Colorectal Surgery Diclofenac - administration & dosage Dosage and administration Endoscopic retrograde cholangiopancreatography Female Gastroenterology Hepatology Humans Incidence Indomethacin Male Medical research Medicine Medicine & Public Health Medicine, Experimental Original Article—Liver Pancreas Pancreatitis Pancreatitis - etiology Pancreatitis - prevention & control Postoperative Complications Prevention Prospective Studies Surgical Oncology Treatment Outcome |
| title | Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial |
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