Intervention Review

Sphincterotomy for biliary sphincter of Oddi dysfunction

  1. Alexander Craig1,*,
  2. James Toouli2

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 22 JAN 2001

Assessed as up-to-date: 5 SEP 2000

DOI: 10.1002/14651858.CD001509


How to Cite

Craig A, Toouli J. Sphincterotomy for biliary sphincter of Oddi dysfunction. Cochrane Database of Systematic Reviews 2001, Issue 1. Art. No.: CD001509. DOI: 10.1002/14651858.CD001509.

Author Information

  1. 1

    Adelaide, Australia

  2. 2

    Flinders Medical Centre, Dept of General and Digestive Surgery, Adelaide, Australia

*Alexander Craig, Adelaide, SA 5042, Australia. sandy@southgastro.com.au.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 22 JAN 2001

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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 methods

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.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Still awaiting evidence for sphincterotomy for biliary sphincter of Oddi dysfunction

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.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

用括約肌切開術治療膽管Oddi括約肌功能障礙

Oddi括約肌控制膽汁和胰液流向十二指腸。如果出現功能障礙,那麼將引起和膽管或胰管相關的問題。 在膽管方面,最常見的問題是實施膽囊切除術之後腹發膽道疼痛。

目標

括約肌切開術能夠有效治療膽管Oddi 括約肌功能障礙的病人嗎?

搜尋策略

搜索多種語言的電子資料庫,包括Collaborative Review Group trial registers, MEDLINE, EMBASE及參考文獻清單檢閱包括下列標題:Oddi功能障礙的括約肌、膽管功能紊亂、乳頭狹窄、 膽管協同失調、膽道口、乳頭炎、膽囊切除術後疼痛、右上腹部疼痛、不明原因的右上腹部疼痛。我們把這些標題和括約肌切開術進行配對。

選擇標準

分析以括約肌切開術治療疑似有膽管Oddi括約肌功能障礙的病人的安慰劑控制隨機對照試驗,以壓力計量測驗作為評估病人的一部分內容。如果基礎壓力大於 40 mmHg,則設定為不正常。試驗的主要結果(outcome)為實施括約肌切開術之後症狀是否有改善反應(界定為痊癒/改善或是沒有改善)

資料收集與分析

使用電子資料庫來搜尋以進行研究。並嘗試將試驗區分為:隨機臨床試驗、對照臨床試驗(如:半隨機臨床試驗),設計良好並且使用正確的對照組的觀察性試驗或其他種類試驗。分組後接著進入統合分析(metaanalysis)。

主要結論

只有2個隨機臨床試驗符合收錄標準。在一個有49位病人的研究中,括約肌切開術比安慰劑更能有效治療基礎壓力升高的病人(Peto odds ratio 9.08, 95% CI 2.97 – 277.77)。在一項有77 位病人的研究中,括約肌切開術在治療基礎壓力正常的病人並未比用安慰劑者較好 (Peto 比數比 1.28, 95% CI 0.52 – 3.13)。沒有關於生活品質或健康經濟學的資料。

作者結論

上述結果指出括約肌切開術能夠有效治療膽管功能障礙的病人,因Oddi括約肌的基礎壓力上升 (>40 mmHg)而造成,但是治療基礎壓力正常的病人,括約肌切開術則未優於安慰劑。因為只有兩個研究,而本研究的一位回顧作家(Toouli)則是該兩個研究其中之一的作者,所以本次文獻回顧的資料必須謹慎解釋。建議未來應該由獨立的團隊來進行研究分析。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

括約肌切開術治療膽管Oddi 括約肌功能障礙還有待進一步的證據證明。 括約肌切開術在治療基礎壓力較高的膽管Oddi 括約肌功能障礙的病人時,看起來似乎是非常引人注意,但是目前不建議在隨機臨床試驗以外的領域使用括約肌切開術。