Need for further randomised clinical trials to assess the role of cholecystectomy in patients with suspected gallbladder dyskinesia

Gallbladder dyskinesia is a motility disorder of the gallbladder (the gallbladder does not contract properly). The disorder is associated with intermittent right upper abdominal pain typically lasting for at least half an hour. The optimal treatment for patients with suspected biliary dyskinesia is controversial. This review evaluates the two alternatives for the diagnosed patient group, that is, cholecystectomy (removal of the gallbladder) versus no intervention. The removal of the gallbladder can be performed by key hole surgery (laparoscopic cholecystectomy) or open surgery (open cholecystectomy). Cholescintigraphy after radiolabeled cholecystokinin (hormone that promotes gallbladder contraction) infusion can measure gallbladder contraction and has been used for the diagnosis of gallbladder dyskinesia. The duration of the cholecystokinin infusion and the cut-off values of ejection fraction (of radioisotope cleared from the gallbladder on contraction) used for the diagnosis of gallbladder dyskinesia are variable, although the most popular cut-off is 35%. Thus, currently, a gallbladder ejection fraction below 35% is considered to be gallbladder dyskinesia. However, there are some doctors who believe that irrespective of ejection fraction, pain related to the gallbladder in the absence of other causes of such pain can be considered gallbladder dyskinesia. One randomised clinical trial including 21 patients found significant cure in pain symptoms after removal of gallbladder (by open surgery) post cholecystectomy (10/11) in patients with a low ejection fraction prior to cholecystectomy compared to those who did not undergo cholecystectomy and had a low ejection fraction (1/10). Further randomised clinical trials of low bias-risk (low risk of systematic error) are necessary to assess the role of cholecystectomy in suspected gallbladder dyskinesia.

Authors' conclusions: 

The evidence for the benefits and harms of cholecystectomy in gallbladder dyskinesia from randomised clinical trials is based on a single small trial at risk of bias. Further randomised clinical trials with improved bias control are necessary to confirm or reject the promising results.

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Background: 

The optimal treatment for patients with suspected biliary dyskinesia is controversial. Some studies found that cholecystectomy produced symptomatic improvement in patients with gallbladder dyskinesia (diagnosed by low gallbladder ejection fraction) while others found no significant benefit. Some studies have shown that gallbladder ejection fraction can discriminate patients who would benefit from cholecystectomy. Other studies have not confirmed this.

Objectives: 

The aim of this review was to compare the benefits and harms of cholecystectomy for patients with suspected gallbladder dyskinesia.

Search strategy: 

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2008.

Selection criteria: 

We considered for inclusion all randomised clinical trials comparing cholecystectomy versus no cholecystectomy on patients with gallbladder dyskinesia.

Data collection and analysis: 

We collected the data on the characteristics, methodological quality, mortality, number of patients in whom symptoms were improved or cured from the one identified trial. We planned to analyse the data using the fixed-effect and the random-effects models using RevMan Analysis. For each outcome we planned to calculate the risk ratio (RR) with 95% confidence intervals based on intention-to-treat analysis.

Main results: 

We included one trial with 21 patients randomised: 11 to cholecystectomy and 10 to control (no cholecystectomy). This trial was considered to be of high risk of bias as patients were not blinded and the procedure-related morbidity was not reported. There was no mortality in either group. All patients in the cholecystectomy group and only one patient in the control group had improvement in symptoms (P = 0.0001) after a mean follow-up period of 33.6 months.

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