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1 All authors: Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi 983-0824, Japan.
Received August 27, 2003;
accepted after revision February 2, 2004.
Address correspondence to K. Ito
(keiito{at}openhp.or.jp).
Abstract
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SUBJECTS AND METHODS. Fifty-eight patients with severe acute cholecystitis who did not improve after antibiotic treatment were included in this study. The patients were randomized into either the percutaneous cholecystostomy group (n = 30) or the gallbladder aspiration group (n = 28). Under sonographic guidance, percutaneous cholecystostomy was performed in the usual manner using a 6.5- or 7-French catheter. Gallbladder aspiration was carried out with a 21-gauge needle under sonographic guidance. The technical success, clinical response, and complications in each group were evaluated.
RESULTS. Percutaneous cholecystostomy and gallbladder aspiration were technically successful in 30 patients (100%) and 23 patients (82%), respectively (not statistically significant). In five patients (18%) of the gallbladder aspiration group, aspiration was unsuccessful because of replacement of bile with dense biliary sludge or pus. Good clinical response was obtained in 27 patients (90%) of the percutaneous cholecystostomy group and in 14 patients (61%) of the gallbladder aspiration group (p < 0.05). As for complications, dislodgment of the catheter occurred in one patient of the percutaneous cholecystostomy group and minor bleeding in one patient after gallbladder aspiration. No major complications or procedure-related deaths occurred in either group.
CONCLUSION. For severe acute cholecystitis, percutaneous cholecystostomy was superior to gallbladder aspiration in terms of clinical effectiveness and had the same complication rate as gallbladder aspiration.
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The patients included were randomized into either the percutaneous cholecystostomy group or the gallbladder aspiration group by means of the sealed envelope method after written informed consent had been obtained. Percutaneous cholecystostomy was performed by puncturing the gallbladder with an 18-gauge needle under sonographic guidance, followed by deployment of a 6.5- or 7-French pigtail catheter using the Seldinger technique. Gallbladder aspiration was carried out with a 21-gauge needle under sonographic guidance. The needle was removed immediately after aspiration of gallbladder contents. Both procedures were performed by trained gastroenterologists. This study was approved by the institutional review board.
Procedure
The technical success rate, clinical response rate, and incidence of early
complications were evaluated in each group. After the procedure, symptoms,
physical findings, and laboratory data such as WBC and C-reactive protein were
recorded on the next day and after 3 days. Percutaneous cholecystostomy and
gallbladder aspiration were regarded as technically successful when a pigtail
catheter was adequately placed in the gallbladder and when sufficient
aspiration of gallbladder contents was achieved and sonography revealed
shrinkage of the gallbladder to less than half its previous size. A positive
clinical response was defined as normalization of at least two of the three
clinical parameters of acute cholecystitis (abdominal pain, fever, and
leukocytosis) within 72 hr. When gallbladder aspiration was technically or
clinically unsuccessful, percutaneous cholecystostomy was performed as a
salvage procedure. Early complications were defined as those occurring within
1 week after the procedure.
Statistical Analysis
In previous reports, the clinical response rate of percutaneous
cholecystostomy in acute cholecystitis was 90–100%. On the basis of our
preliminary study, we expected the clinical response rate of gallbladder
aspiration to be 60%. Thirty-three patients were needed in each group to
achieve a ß value of 0.2 and an 
error of 5%.
The results were analyzed per protocol; all patients who underwent percutaneous cholecystostomy after gallbladder aspiration as a salvage procedure were included in the analysis. The Fisher's exact test, Student's t test, and Mann-Whitney U test were used for statistical analysis. A p value of less than 0.05 was regarded as significant.
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Percutaneous cholecystostomy and gallbladder aspiration were technically successful in 30 patients (100%) and 23 patients (82%), respectively, without statistically significant difference. In five patients (18%) of the gallbladder aspiration group, bile, consisting of biliary sludge or pus, was too thick to be aspirated. Good clinical response was obtained in 27 patients (90%) of the percutaneous cholecystostomy group and 14 patients (61%) of the gallbladder aspiration group (p < 0.05). Three patients in the percutaneous cholecystostomy group who did not achieve clinical response within 72 hr showed a positive clinical response after 72 hr. Twelve patients who did not achieve clinical response within 72 hr in the gallbladder aspiration group underwent percutaneous cholecystostomy and showed a positive clinical response after that procedure.
Early complications occurred in one patient (3%) (dislodgment of catheter) in the percutaneous cholecystostomy group. The event occurred 2 days after the procedure, but the catheter did not need to be replaced. Mild bleeding occurred after gallbladder aspiration in one patient (4%) with liver cirrhosis showing no coagulopathy. Bleeding into the gallbladder occurred immediately after removal of the needle and spontaneously stopped in a few minutes. The patient underwent percutaneous cholecystostomy 1 day after gallbladder aspiration because of no improvement of clinical symptoms. Although the gallbladder contents were blood, blood transfusion was not necessary. No major complications or procedure-related deaths occurred in either of the two groups.
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Since Radder [20] reported the first sonographically guided percutaneous cholecystostomy for the drainage of gallbladder empyema, several studies have confirmed the efficacy of this procedure in acute cholecystitis [21–25]. Borzellino et al. [11] reported 84 patients older than 70 years who had acute cholecystitis treated by percutaneous cholecystostomy. Technical success and good clinical response were achieved in 83 patients. Elective cholecystectomy was then performed in 70 patients with no deaths and a morbidity rate of 24%. Berber et al. [12] and Spira et al. [13] concluded that tube cholecystostomy with elective laparoscopic cholecystectomy was useful in the management of selected patients with acute cholecystitis. Kuster and Domagk [9] reported that laparoscopic cholecystostomy for acute cholecystitis decreased the conversion rate to open surgery from 11% to 1.5%. Kim et al. [26] reported that percutaneous cholecystostomy was successfully performed in 33 patients with acute cholecystitis. Consequently, 26 patients with gallstones underwent percutaneous transhepatic cholecystoscopy, and concomitant stone removal was successfully carried out in one to four consecutive sessions. These studies suggest that tube cholecystostomy for acute cholecystitis enables selection of treatment options such as laparoscopic cholecystectomy or cholecystoscopic stone removal and improves the safety of elective surgery in selected patients.
On the other hand, gallbladder aspiration, which was introduced as a diagnostic procedure [14, 16, 17], is becoming therapeutic in high-risk patients with acute cholecystitis [15, 18]. Contrary to percutaneous cholecystostomy for acute cholecystitis, which enables continuous drainage, gallbladder aspiration provides only one-time gallbladder decompression and drainage of the contents. Therefore, these two procedures are fundamentally different. Because patients with acute cholecystitis often improve by antibiotic treatment, the effectiveness of gallbladder aspiration should not be estimated by retrospective studies or noncomparative studies. To our knowledge, only one study has compared the efficacy of gallbladder aspiration with that of percutaneous cholecystostomy [19]. Chopra et al. [19] reported that gallbladder aspiration and percutaneous cholecystostomy were technically successful in 97% and 97%, respectively, and clinical improvement was achieved in 77% and 90%, respectively. Complications occurred in 0% and 14%. They suggested that gallbladder aspiration was significantly safer than percutaneous cholecystostomy and should be the procedure of choice in high-risk patients with acute cholecystitis. A possible cause of discrepancy in the efficacy of gallbladder aspiration between our study and that of Chopra et al. is the difference in the size of the needle used. A small sample size in their study may be another reason. The efficacy of gallbladder aspiration and that of tube cholecystostomy in their study were 77% and 90%, respectively (p = 0.10). Given the small sample size, they may have failed to show a difference. Because their study was a nonrandomized and retrospective study, a prospective randomized trial is necessary to evaluate the efficacy of the two procedures.
We carried out a prospective randomized controlled trial to compare and determine the effectiveness and safety of percutaneous cholecystostomy and gallbladder aspiration in cases of severe acute cholecystitis. We excluded patients with pericholecystic abscess because such patients require continuous drainage of the gallbladder. Consequently, percutaneous cholecystostomy was more effective than gallbladder aspiration in terms of clinical effectiveness. Our study showed that thick bile or pus could not be aspirated sufficiently by gallbladder aspiration using a 21-gauge needle. Although needles thicker than 19-gauge in diameter may facilitate aspiration of thick bile or pus, because of the risk of increased bleeding we chose thinner needles. However, an 18-gauge needle was successfully used in the study of Chopra et al. [19] in 97% of the patients, and no complications occurred. Our study shows the results of gallbladder aspiration with a 21-gauge needle. Room for improvement may be possible for the technical success rate in gallbladder aspiration. Further studies on the correlation between the needle size and its effectiveness and safety are necessary. Our overall complication rate of 3% in percutaneous cholecystostomy is low compared with previously reported rates of 4–24% [11, 13, 19, 24], which means that the size of the catheter we used was sufficiently large for successful drainage and offered increased safety. Dislodgment of a catheter occurred in one patient. The patient required no catheter replacement. The overall morbidity rates were the same in the two groups.
In conclusion, percutaneous cholecystostomy rather than gallbladder aspiration is the treatment of choice for patients with severe acute cholecystitis who are at high surgical risk.
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