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1
Department of Radiology, Mail Code 7800, University of Texas Health Science
Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229.
2
Department of Surgery, University of Texas Health Science Center at San
Antonio, San Antonio, TX 78229.
Received March 27, 2000;
accepted after revision September 20, 2000.
Address correspondence to S. Chopra.
Abstract
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MATERIALS AND METHODS. Medical records of 53 consecutive non—critically ill, high-surgical-risk patients admitted with acute cholecystitis between July 1995 and July 1999 were reviewed. Thirty-one had gallbladder aspiration and 22 had percutaneous cholecystostomy. The primary outcome measure of clinical response within 72 hr and the secondary outcome measures of overall positive response rate, complication rate, time to resolution, and rate of recurrence of acute cholecystitis were compared between the two groups.
RESULTS. Gallbladder aspiration and percutaneous cholecystostomy were technically successful in 30 (97%) and 21 (97%) patients, respectively; of these, 23 (77%) and 19 (90%) patients responded clinically within 72 hr (p > 0.2). Complications occurred in three patients (12%) after percutaneous cholecystostomy and in none after gallbladder aspiration (p < 0.05). No significant difference was noted in the other secondary outcome measures of the two groups.
CONCLUSION. We found no significant difference in the clinical outcomes of gallbladder aspiration and percutaneous cholecystostomy in the treatment of acute cholecystitis in high-surgical-risk patients who are not critically ill. However, we found gallbladder aspiration to be significantly safer. Therefore, gallbladder aspiration should be the procedure of choice in high-risk patients with acute cholecystitis who are not critically ill, and percutaneous cholecystectomy should be reserved as a salvage procedure if gallbladder aspiration is technically or clinically unsuccessful.
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Diagnostic gallbladder aspiration through a needle placed percutaneously in the gallbladder lumen under imaging guidance has been reported [16, 17]. However, to our knowledge only a few reports describe the use of gallbladder aspiration in the treatment of acute cholecystitis in high-risk patients [18,19,20]. None of these studies has compared the efficacy of gallbladder aspiration with that of percutaneous cholecystostomy. In our clinical practice in a tertiary care teaching hospital, our approach to the treatment of acute cholecystitis in the high-risk patient before 1997 was to obtain gallbladder decompression using percutaneous cholecystostomy. In 1997, because of the comparative simplicity of performing gallbladder aspiration, we made a decision to alter the existing approach to adopt gallbladder aspiration as the initial procedure, using percutaneous cholecystostomy only as a salvage procedure in patients who did not respond to gallbladder aspiration. We conducted a retrospective medical record review of patients treated in our department to compare the clinical outcomes of gallbladder aspiration and percutaneous cholecystostomy in the treatment of acute cholecystitis in high-surgical-risk patients.
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Review of the medical records of the study patients showed that all had comorbid conditions producing an unacceptably high risk for cholecystectomy (Table 1). The diagnosis of acute cholecystitis was suspected on the basis of right upper quadrant pain and tenderness, fever, or leukocytosis. All patients underwent sonography as the initial confirmatory test for acute cholecystitis. The sonographic diagnostic criteria used are shown in the Appendix and are illustrated in Figures 1A and 2A. Sonography was diagnostic of acute cholecystitis in 40 patients (75%), equivocal in 10 (19%), and normal in three (6%). In patients with equivocal or normal sonographic findings, the diagnosis was confirmed with hepatobiliary scintigraphy using standard criteria [21]. All sonograms and hepatobiliary scintigrams were obtained using state-of-the-art equipment and standard techniques implemented by qualified technologists, and all were supervised and interpreted by board-certified radiologists.
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Patients belonging to both the gallbladder aspiration and the percutaneous cholecystostomy groups were admitted to the hospital, allowed no oral feeding, and administered broad-spectrum IV antibiotics. Coagulopathy, if present, was corrected with transfusions of fresh frozen plasma or platelets or both, as indicated. Light IV sedation was used in patients who were apprehensive. All procedures (gallbladder aspiration and percutaneous cholecystostomy) were performed in the interventional suite under aseptic conditions, using local anesthesia and a transhepatic route by trained interventional radiologists. An 18-gauge echogenic-tip needle was used to puncture the gallbladder for gallbladder aspiration (Fig. 1B). Gallbladder aspiration was considered technically successful when complete aspiration of the gallbladder contents was achieved (Fig. 1C), and the needle was removed. All percutaneous cholecystostomies were performed with the Seldinger technique using commercially available 18-gauge echogenic-tip needles (Fig. 2B), 0.038-inch guidewires (Fig. 2C), and 6- to 10-French pigtail catheters (Fig. 2D). Percutaneous cholecystostomy was considered technically successful when the pigtail catheter loop was visualized sonographically in the gallbladder lumen (Fig 2D) and the gallbladder contents could be aspirated freely through the percutaneous cholecystostomy catheter. All patients had their vital signs monitored and were observed for symptoms of local pain or shoulder discomfort for 4 hr after the procedure. In patients who had a difficult procedure, a chest radiograph was obtained to exclude pneumothorax. Right upper quadrant pain, fever, and leukocytosis were monitored in all patients.
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A positive clinical response was defined as normalization of at least two of the three clinical parameters of acute cholecystitis (right upper quadrant pain, fever, and leukocytosis) with subsequent resolution and freedom from recurrence for at least 1 month, or improvement in the overall clinical status sufficient to permit cholecystectomy. The frequency of positive clinical response at 72 hr was selected as the primary measure of clinical outcome. Patients who showed no positive clinical response at 72 hr after percutaneous cholecystostomy were treated with continued catheter drainage; those whose showed no positive clinical response at 72 hr after gallbladder aspiration were salvaged with a percutaneous cholecystostomy.
After recovery from acute cholecystitis, patients were followed up until surgery, recurrence, or death, whichever occurred first. In patients with percutaneous cholecystostomy in whom the comorbid condition persisted, long-term catheter drainage was continued, with a change of catheter every 3 months. The secondary measures of clinical outcome were the overall frequency of positive clinical response obtained by adding the number of patients in the gallbladder aspiration or percutaneous cholecystostomy groups who showed clinical response at 72 hr to those who recovered after the salvage percutaneous cholecystostomy or after continued catheter drainage, respectively; complication rates; time to clinical resolution; the length of time the catheter drainage continued in patients with percutaneous cholecystostomy; and the frequency of recurrence after 1 month.
The gallbladder aspiration and percutaneous cholecystostomy groups were statistically compared regarding their demographic, comorbid, clinical, laboratory, and imaging features. Technical success rates of gallbladder aspiration and percutaneous cholecystostomy were compared in all patients, and the clinical outcomes were compared only in patients in whom the procedures were technically successful. We compared the frequencies of the primary and secondary outcome measures in the gallbladder aspiration group with those in the percutaneous cholecystostomy group. To assess the effect of patient characteristics on clinical outcomes, we compared the frequencies of the positive clinical response at 72 hr in each group among patients with and without the various demographic, clinical, laboratory, and imaging features shown in Table 2. We used Fisher's exact test for comparing categoric variables and the Student's t test for numeric variables in all analyses. We also assessed the significance of the difference between the frequencies of positive clinical response at 72 hr and the overall frequency of positive clinical response in each group using the sign test.
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All statistical analysis was carried out by a professional statistician using SAS statistical software (SAS Institute, Cary, NC). All statistical tests were two-tailed. Values for p of less than 0.05 were considered statistically significant.
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Technical Success Rates
Gallbladder aspiration was technically successful in 30 patients (97%) and
failed in one in whom the bile was too thick to be aspirated through an
18-gauge needle because of biliary sludge. Percutaneous cholecystostomy was
technically successful in 21 patients (95%) and failed in one patient in whom
the gallbladder was filled with stones and would not accommodate a pigtail
catheter. No significant difference was seen in the technical success rates of
the two procedures (p > 0.7).
Clinical Outcome
Of the 30 and 21 patients with technically successful gallbladder
aspiration and percutaneous cholecystostomy, a positive clinical response at
72 hr was seen in 23 (77%) and 19 (90%), respectively
(Table 3); the difference was
not statistically significant (p > 0.1).
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All seven patients in the gallbladder aspiration group who did not show a positive clinical response at 72 hr underwent salvage percutaneous cholecystostomy with a positive clinical response occurring in six patients (18%) and death in one (3%). In the two patients in the percutaneous cholecystostomy group who did not show a clinical response at 72 hr, catheter drainage was continued. Of these, one patient showed a positive clinical response and the other died. Thus, 29 patients (97%) treated with gallbladder aspiration and salvage percutaneous cholecystostomy and 20 patients (95%) treated with percutaneous cholecystostomy showed a positive clinical response. No significant difference was seen between the two groups treated with these two approaches (p > 0.6). However, the addition of salvage percutaneous cholecystostomy significantly improved the overall frequency of positive clinical response in patients who were treated with gallbladder aspiration (p < 0.05).
Effect of Patient Characteristics on Clinical Outcome
No patient characteristic significantly affected the outcome after
gallbladder aspiration or percutaneous cholecystostomy. However, in the
gallbladder aspiration group, 11 (48%) of the 23 patients who showed a
positive clinical response at 72 hr had positive bile cultures, whereas five
(83%) of six patients who showed a positive clinical response only after
salvage percutaneous cholecystostomy had positive bile cultures. Nonetheless,
the difference did not reach statistical significance.
Other Secondary Outcome Measures
During percutaneous cholecystostomy, complications of right pneumothorax,
hepatic subcapsular hematoma, and misplacement of the catheter were seen in a
significantly higher number of patients (n = 3 [14%]) than after
gallbladder aspiration that had no complications (p < 0.05).
The mean time to complete resolution of the clinical parameters of acute cholecystitis was 4.4 days (range, 1-14 days) in patients in the gallbladder aspiration group and 3.8 days (range, 1-14 days) in patients in the percutaneous cholecystostomy group. The difference was not statistically significant (p > 0.5).
Mean duration of follow-up was 482 days (range, 27-661 days) and 562 days (range, 25-1492 days), respectively, for patients in the gallbladder aspiration and percutaneous cholecystostomy groups with overall resolution. Of the 29 such patients in the gallbladder aspiration group and 20 in the percutaneous cholecystostomy group, seven (24%) and four (20%), respectively, had subsequent cholecystectomy, one (3%) and two (10%) succumbed to their comorbid conditions, and 28 (97%) and 18 (90%) were living at the time of data collection. Of the 21 patients with technically successful percutaneous cholecystostomy, the percutaneous cholecystostomy catheter was in situ for less than 1 month in six patients (29%), 30-179 days in six (29%), and 180 days or more in nine (43%). Recurrence of acute cholecystitis more than 1 month after the procedure was seen in one patient from each group. Both were successfully treated with percutaneous cholecystostomy.
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Gallbladder aspiration is fundamentally different from percutaneous cholecystostomy in that gallbladder aspiration provides only onetime gallbladder decompression. On the surface, this appears to go against the traditional surgical principle of treating infected collections with continuous drainage. Therefore, despite its potential advantages, gallbladder aspiration has not been widely adopted in the treatment of acute cholecystitis in high-surgical-risk patients. We performed this study to compare the clinical outcomes of gallbladder aspiration and percutaneous cholecystostomy. To our knowledge, ours is the only study comparing gallbladder aspiration and percutaneous cholecystostomy and elucidating the concept of a salvage procedure in patients in whom the initial gallbladder aspiration fails.
The results of our study suggest that no significant difference exists between the clinical outcomes of high-surgical-risk patients with acute cholecystitis treated with gallbladder aspiration or those treated with percutaneous cholecystostomy. Clinical response was seen within 72 hr in 77% and 90% of patients after gallbladder aspiration and percutaneous cholecystostomy, respectively (p > 0.6). In our opinion, the similarity of clinical outcomes in patients treated with gallbladder aspiration and percutaneous cholecystostomy can be explained on the basis of the pathogenesis of acute cholecystitis. Three factors are potentially active in the development of acute cholecystitis: increased intraluminal pressure due to obstruction, chemical injury of the mucosa from bile salts, or bacterial infection [1]. Infection is not present in all patients. Indeed, bile cultures were positive in only 49% of our patients, similar to the frequency of 16-48% described by other authors [6, 12, 17, 22]. Therefore, continuous drainage may not be the critical element in the treatment of acute cholecystitis. One-time aspiration of bile from the obstructed gallbladder removes the irritant luminal contents and reduces the intraluminal pressure. In our opinion, in most patients, even those with infected bile, this one-time aspiration is enough to cause resolution of acute cholecystitis. However, in a small but significant proportion of patients, one-time gallbladder aspiration may not be sufficient. In our series, 23% of patients did not show a clinical response at 72 hr after gallbladder aspiration. Although not statistically significant, this number appeared to be higher among patients with infected bile. In such a situation, the concept of a salvaging procedure to repeat the gallbladder decompression proves useful. Verbanck et al. [19] used repeated gallbladder aspiration in patients who did not respond within 72 hr and increased the frequency of response from 15 patients (83%) after a single gallbladder aspiration to 17 (94%) with repeated gallbladder aspiration in a series of 18 patients with infected bile. In our institution, we adopted a different clinical approach by using percutaneous cholecystostomy as a salvage procedure. Using the approach of gallbladder aspiration with salvage percutaneous cholecystostomy, we were able to avoid percutaneous cholecystostomy in 77% of patients while obtaining the overall frequency of positive clinical response close to that of percutaneous cholecystostomy.
Our study also elucidates some of the advantages of gallbladder aspiration over percutaneous cholecystostomy. First, the complication rate of gallbladder aspiration is significantly lower than that of percutaneous cholecystostomy (p < 0.05). This is to be expected because gallbladder aspiration is a one-step procedure performed with an 18-gauge needle, whereas percutaneous cholecystostomy, when performed using the Seldinger method, is a three-step procedure involving using a much thicker 8-French catheter. Second, gallbladder aspiration does not lead to the patient's being discharged with an indwelling tube. In our patients, percutaneous cholecystostomy was maintained in situ for more than 1 month in 71% and for more than 6 months in 42% of patients. It could be argued that prolonged percutaneous cholecystostomy drainage, unlike gallbladder aspiration, helps avoid long-term recurrence of acute cholecystitis in patients who are unfit for surgery. This effect was not observed in our study because the long-term recurrence rates of gallbladder aspiration and percutaneous cholecystostomy were not significantly different. Third, our experience showed that gallbladder aspiration was much quicker, and the cost of materials was a fraction of that for percutaneous cholecystostomy. Therefore, adopting the approach of gallbladder aspiration with salvage percutaneous cholecystostomy or repeated gallbladder aspiration is likely to result in fewer complications, reduced patient discomfort, and savings of time and money.
In a few situations percutaneous cholecystostomy is preferable to gallbladder aspiration. Gallbladder aspiration may not be technically feasible in patients with viscous, sludge-laden bile. In such patients, percutaneous cholecystostomy has more likelihood of succeeding because of the larger caliber of the catheter. Also, because it does not provide continuous drainage, gallbladder aspiration is inappropriate in patients in whom the indication for gallbladder drainage is to provide relief from a distal biliary obstruction.
Our study has two major limitations. First, it is a nonrandomized and retrospective study. Second, we excluded patients who developed acute cholecystitis in the prolonged intensive care setting. Although we recognize that such patients may from the bulk of those requiring percutaneous decompression of the gallbladder in some institutions, such was not our experience. During the study period, only 16 (23%) of the 70 patients who underwent gallbladder decompression were in the intensive care unit. Most of these patients had undergone percutaneous cholecystostomy rather than gallbladder aspiration. Because various authors have shown the results of percutaneous cholecystostomy in critically ill patients to be much worse than in non-critically ill patients, the inclusion of critically ill patients would have created a selection bias against percutaneous cholecystostomy [9, 12, 22, 23]. In addition, making the diagnosis in patients who develop acute cholecystitis in the prolonged intensive care setting is difficult. Such patients often present with unexplained sepsis, are insensitive to pain, have hypoalbuminemia and hydration issues that may independently cause gallbladder wall thickening, and have poor excretory liver function, thus making the scintigraphic diagnosis less accurate. Indeed, many times percutaneous cholecystostomy is performed in these patients as a therapeutic test to exclude the gallbladder as the cause of sepsis. In such a situation it would be difficult to assess whether the lack of response to percutaneous cholecystostomy or gallbladder aspiration is caused by the failure of the procedure or by an erroneous diagnosis of acute cholecystitis. Further studies will be required to elucidate this point.
In conclusion, we found no significant difference in the clinical outcomes of gallbladder aspiration and percutaneous cholecystostomy in the treatment of acute cholecystitis in high-surgical-risk patients outside the ICU setting. However, gallbladder aspiration is significantly safer than percutaneous cholecystostomy. Therefore, gallbladder aspiration should be the procedure of choice in high-surgical-risk patients with acute cholecystitis, and percutaneous cholecystostomy should be reserved as a salvage procedure if gallbladder aspiration is technically or clinically unsuccessful.
APPENDIX: Sonographic Signs of Acute Cholecystitis
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Acknowledgments
We thank John Schoolfield for statistical analysis.
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