| Botulinum toxin injection after biliary sphincterotomy. | |
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MedLine Citation:
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PMID: 14765315 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND AND STUDY AIMS: Endoscopic biliary sphincterotomy in patients with sphincter of Oddi dysfunction (SOD) is associated with a high risk of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP), which may be secondary to residual pancreatic sphincter hypertension. It was hypothesized that botulinum toxin injection could be used to reduce pancreatic sphincter hypertension temporarily in SOD patients after biliary sphincterotomy, thereby reducing the rate of procedure-induced pancreatitis. PATIENTS AND METHODS: All patients undergoing ERCP with manometry due to a suspected biliary SOD were asked to participate in the study. Patients with elevated basal sphincter pressures were randomly assigned to receive either botulinum toxin or a sham saline injection after biliary sphincterotomy. Fifty units of botulinum toxin were delivered via a sclerotherapy needle in the form of two 25-U injections of 0.25 ml each into the pancreatic sphincter. In patients in the sham arm, 0.50 ml of saline was injected into the duodenal lumen. RESULTS: Between 12 February 1999 and 29 November 2000, a total of 98 patients were referred for ERCP with manometry; 86 consented to participate in the study, and 26 had elevated baseline pressures and underwent random assignment. Twelve received botulinum toxin injection and 14 were randomly assigned to receive the sham injection. A total of six patients in the sham group (43 %) developed procedure-induced pancreatitis, compared with three patients in the botulinum toxin group (25 %; P = 0.34). CONCLUSIONS: Biliary sphincterotomy in patients with sphincter of Oddi dysfunction without pancreatic protection is risky and should no longer be carried out. This study demonstrates that botulinum toxin injection into the residual pancreatic sphincter after biliary sphincterotomy is technically feasible and safe, showing a trend toward a reduced post-ERCP pancreatitis rate in patients with sphincter of Oddi dysfunction. Further studies will need to confirm the validity of these experimental results before this technique can be used routinely. |
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Authors:
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A Gorelick; J Barnett; W Chey; M Anderson; G Elta |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Endoscopy Volume: 36 ISSN: 0013-726X ISO Abbreviation: Endoscopy Publication Date: 2004 Feb |
Date Detail:
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Created Date: 2004-02-06 Completed Date: 2004-06-22 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0215166 Medline TA: Endoscopy Country: Germany |
Other Details:
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Languages: eng Pagination: 170-3 Citation Subset: IM |
Affiliation:
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Connecticut Gastroenterology Consultants, PC, New Haven, Connecticut, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acute Disease Adult Aged Botulinum Toxin Type A / administration & dosage*, therapeutic use Cholangiopancreatography, Endoscopic Retrograde / adverse effects*, methods Common Bile Duct Diseases / diagnosis, physiopathology, surgery* Female Humans Male Manometry Middle Aged Neuromuscular Agents / administration & dosage*, therapeutic use Pancreatitis / etiology, prevention & control* Prospective Studies Sphincter of Oddi / drug effects*, physiopathology Sphincterotomy, Endoscopic / adverse effects*, methods Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Botulinum Toxin Type A; 0/Neuromuscular Agents |
| Comments/Corrections | |
Comment In:
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Endoscopy. 2004 Aug;36(8):744; author reply 745
[PMID:
15280987
]
Endoscopy. 2004 Feb;36(2):179-82 [PMID: 14765317 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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