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No Clarity for Cholecystectomy
Abstract & commentary
By Malcolm Robinson, MD, FACP, FACG, AGAF, Emeritus Clinical Professor of Medicine, University of Oklahoma College of Medicine, Oklahoma City. Dr. Robinson reports no financial relationship to this field of study.
Synopsis: We don't have the slightest idea whether evidence of gallbladder dyskinesia should warrant cholecystectomy or not.
Source: Gurusamy KS, et al. Cholecystectomy for suspected gallbladder dyskinesia. Cochrane Database Syst Rev 2009;(1):CD007086; doi: 10.1002/14651858.CD007086.pub2.
Gallbladder dyskinesia, defined as a gallbladder motility disorder (usually with scintigraphic evidence of subnormal gallbladder emptying), is thought to be associated with symptoms that include right upper quadrant pain lasting half an hour or longer. Many surgeons and some gastroenterologists believe that gallbladder scintigraphy should be performed in patients with suspected cholecystitis who have had negative ultrasound studies for gallstones. Scintigraphic studies include the administration of cholecystokinin to induce gallbladder contraction. Although there is some disagreement about specific numbers, a 35% ejection fraction seems to be generally accepted as the lower limit of normal. If less than 35% of gallbladder contents are emptied, dyskinesia is diagnosed and cholecystectomy in such patients has been urged by many clinicians. In one randomized clinical trial, open cholecystectomy largely eliminated symptoms in 10 of 11 patients with low gallbladder ejection fractions. Only 1 of 10 patients who did not undergo surgery had similar symptom resolution. It has also been reported that more than two-thirds of resected gallbladders after cholecystectomy for gallbladder dyskinesia have pathologic evidence for chronic acalculous cholecystitis. On the other hand, studies have indicated similar improvements after cholecystectomies in patients with or without findings of gallbladder dyskinesia. Although cholecystectomies are usually considered to be low morbidity procedures, there can be severe complications up to and including death. This Cochrane review was designed to evaluate the world's literature on the subject of cholecystectomy for gallbladder dyskinesia. A total of 238 references were initially identified, of which 175 were found to be irrelevant and 61 to be duplicates. The final result was the identification of a single relevant study. However, the authors felt that this trial (as outlined above) was unblinded and at high risk of bias. The endpoint of "improvement in symptoms" was felt to be rather weak. This review concluded that further large randomized trials should be undertaken and that the nonsurgical group should have sham procedures performed including sedation and skin incisions.
Cochrane reviews are often felt to be the ultimate source of data mining to resolve difficult clinical issues like the value of cholecystectomy in patients with scintigraphically documented gallbladder dyskinesia. My review of this manuscript was therefore undertaken with considerable enthusiasm and the hope that the question would be resolved once and for all. Needless to say, the presence of a single relevant study was very disappointing. In clinical practice, there have been very large numbers of cholecystectomies performed on the basis of gallbladder dyskinesia. It seems fair to say that this practice cannot be justified on the basis of any meaningful evidence. Chronic acalculous cholecystitis is a very soft pathological diagnosis, often meaning that there were a few extra chronic inflammatory cells present. In my view, this is a questionable diagnosis at best. Although it is not possible to state that no patient with gallbladder dyskinesia should ever have cholecystectomy, it is clear that scintigraphy has minimal utility when compared to gallbladder ultrasound for gallstones. Although not addressed in the manuscript being reviewed, gallbladder scintigraphy seems to share many characteristics with other fuzzy diagnostic techniques such as the analysis of biliary contents of the duodenum for crystals. Even if it were agreed that cholecystectomy is exceptionally safe, it is definitely not inexpensive. In today's world of imperative medical cost controls, it seems reasonable to curtail payments for interventions that are as weakly substantiated as cholecystectomy for suspected gallbladder dyskinesia. By the way, the likelihood that Institutional Review Boards or patients would accept enrollment in studies involving sham surgery with sedation seems negligible.