Sphincterotomy for biliary sphincter of Oddi dysfunction in patients with a manometrically documented high basal pressure looks attractive, but should not be offered outside new randomised clinical trials.

This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2010 Issue 9, Copyright © 2010 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This record should be cited as: Craig A, Toouli J. Sphincterotomy for biliary sphincter of Oddi dysfunction. Cochrane Database of Systematic Reviews 2001, Issue 3. Art. No.: CD001509. DOI: 10.1002/14651858.CD001509

Editorial Group: Hepato-Biliary Group

This version first published online: July 23. 2001
Last assessed as up-to-date: September 6. 2000

Abstract

Background

The sphincter of Oddi regulates both bile and pancreatic juice flow into the duodenum. When dysfunction occurs it leads to problems relating to either the bile or pancreatic ducts. On the biliary side, the most common problem is recurrent biliary type pain following cholecystectomy.

Objectives

Is sphincterotomy effective treatment for biliary sphincter of Oddi dysfunction patients?

Search strategy

Electronic data bases, including the Collaborative Review Group trial registers, MEDLINE, and EMBASE, as well as checking reference lists in as many languages as possible that had the titles: sphincter of Oddi dysfunction, biliary dyskinesia, papillary stenosis, biliary dyssynergia, odditis, papillitis, post-cholecystectomy pain, right upper quadrant pain, or unexplained right upper quadrant pain were included. These titles were matched with sphincterotomy.

Selection criteria

Randomised placebo-controlled trials performing sphincterotomy in patients with suspected biliary sphincter of Oddi dysfunction using manometry as part of the patient evaluation. A basal pressure > 40 mmHg was defined as abnormal. The primary outcome measure was symptomatic response (defined either as cure/improvement or not improved) to sphincterotomy.

Data collection and analysis

Electronic data bases were used to search for the studies. Studies were attempted to be stratified as randomised clinical trials, controlled clinical trials (i.e., quasi-randomised clinical trials), well designed observational studies using a well matched control group, or other. These groupings were then entered into a meta-analysis.

Main results

Only two randomised clinical trials met the inclusion criteria. In 49 patients studied, sphincterotomy was more effective than placebo in treating patients with an elevated basal pressure (Peto odds ratio 9.08, 95% confidence interval 2.97-277.77). In 77 patients studied, sphincterotomy was no better than placebo in treating patients with a normal basal pressure (Peto odds ratio 1.28, 95% confidence interval 0.52-3.13). There were no data on quality of life or health economics.

Authors' conclusions

These results suggest that sphincterotomy for biliary sphincter of Oddi dysfunction appears effective in those patients with an elevated sphincter of Oddi basal pressure (>40 mmHg), but is no better than placebo in those patients with a normal basal pressure. The results reported in this review must be interpreted with caution as there are only two studies and one of the reviewers (Toouli) has been an author in both studies. Further trials by independent groups are recommended.

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