Evaluating the Controversial Role of Cholecystostomy in Clinical Practice PDF

HOW I DO IT Evaluating the Controversial Role of Cholecystostomy in Current Clinical Practice Jonathan M. Lorenz, M.D.1 P ercutaneous cholecystostomy (PC) for the tion, randomized, controlled trials should attempt to treatment of acute cholec...

HOW I DO IT Evaluating the Controversial Role of Cholecystostomy in Current Clinical Practice Jonathan M. Lorenz, M.D.1 P ercutaneous cholecystostomy (PC) for the tion, randomized, controlled trials should attempt to treatment of acute cholecystitis is increasing in popular- address the following unanswered questions: ity, and has served as a definitive treatment, a bridge to surgery, or a means toward other minimally invasive 1. What is the procedural and 30-day morbidity and therapies. The absence of quality literature supporting a mortality of PC, open cholecystectomy, and laparo- clear definition of the role of PC and related adjunctive scopic cholecystectomy, and can untoward events therapies in the treatment of acute cholecystitis often resulting from comorbidities be distinguished from results in inconsistent application of this treatment those resulting from these procedures? option in clinical practice. Because excellent overviews 2. What is the rate of recurrence of acute cholecystitis of the technique of PC and associated clinical manage- after removal of cholecystostomy drains placed for ment have been published recently,1 this article focuses both acute calculous and acalculous cholecystitis? on the controversial indications, complications, and 3. For patients presenting with acute calculous chole- evolving roles of percutaneous cholecystostomy and cystitis, what is the morbidity and mortality after related therapies. cholecystostomy coupled with adjunctive therapies such as percutaneous gallbladder ablation? 4. How do complication rates of those adjunctive pro- THE CONTROVERSIAL ROLE OF cedures compare with complication rates of surgical CHOLECYSTOSTOMY cholecystectomy? PC is primarily indicated for accessing the gallbladder to 5. As technical improvements and clinical experience in manage cholecystitis or to serve as a portal to remove or laparoscopic cholecystectomy have improved, how dissolve gallstones.2 In the current literature and in does up-to-date laparoscopic cholecystectomy com- clinical practice, our colleagues in surgery and internal pare with PC with respect to procedural and 30-day medicine continue to recommend PC as an alternative to morbidity and mortality? surgical cholecystectomy in patients with acute chole- cystitis deemed poor surgical candidates. This trend is based largely on low-grade, retrospective studies and The current literature fails to answer these ques- anecdotal clinical experience, which result in an incon- tions and to establish precise guidelines for the applica- sistent and unsupported utilization of PC. The recom- tion of PC in actual clinical practice because of the mendation of PC over surgical alternatives will continue following limitations: to be based largely on clinical intuition until randomized, controlled trials answer a series of questions regarding 1. Randomized, controlled trials are limited and scant, the treatment of acute cholecystitis. In summary, con- leaving the basis for clinical decisions regarding the trolling for age, clinical parameters supporting the diag- treatment of acute cholecystitis to anecdotal clinical nosis, comorbidities, clinical signs of local or systemic experience, poorly defined clinical parameters for infection, hemodynamic status, renal failure, and com- establishing the diagnosis of acute cholecystitis, and plications such as gallbladder rupture or abscess forma- reluctance by surgeons to operate based on factors 1 The University of Chicago, Chicago, Illinois. M.D. Address for correspondence and reprint requests: Jonathan M. Semin Intervent Radiol 2011;28:444–449. Copyright # 2011 by Lorenz, M.D., The University of Chicago, 5841 S. Maryland Ave. Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY MC2026, Chicago, IL 60637 (e-mail: [email protected] 10001, USA. Tel: +1(212) 584-4662. go.edu). DOI: http://dx.doi.org/10.1055/s-0031-1296087. Genitourinary Intervention; Guest Editor, Darryl A. Zuckerman, ISSN 0739-9529. 444  EVALUATING THE CONTROVERSIAL ROLE OF CHOLECYSTOSTOMY IN CURRENT CLINICAL PRACTICE/LORENZ 445 such as comfort level, operative experience, and the PC other than the after-hours avoidance of emergent time of day. cholecystectomy procedures on-call. 2. Retrospective studies tend to bias PC toward more Although some surgeons3 suggest that improve- critically ill and unstable patients with a host of ments in laparoscopic technique in recent years may comorbidities deemed unsuitable by surgeons for obviate the need for PC in many cases, it should be both general anesthesia and cholecystectomy. Thus, noted that in the emergent setting, the reported con- the PC cohort is likely to suffer spuriously high rates version rates to open cholecystectomy have been histor- of morbidity and mortality compared with the surgi- ically high—often exceeding 15%.4 Given this cally treated cohort. information, when weighing the comparative risks of 3. Retrospective studies tend to underestimate the clin- PC versus surgery in high-risk patients, perhaps open ical success of PC because clinical support for the rather than laparoscopic surgery should be considered diagnosis of acute cholecystitis is highly variable. PC the comparative surgical option. is often prescribed for soft indicators such as ‘‘high As the era of evidence-based medicine pro- clinical suspicion’’ despite little to no imaging evi- gresses, all physicians have had to accept the fact dence as compared with hard indicators such as that many treatments are deemed indicated despite indisputable findings on hepatobiliary iminodiacetic only anecdotal or theoretical evidence, expert clinical acid (HIDA) scan, ultrasound, or cross-sectional intuition, and the absence of prospective randomized imaging studies. Because a cholecystostomy tube is studies. The bottom line remains: PC is performed unlikely to improve the clinical picture if acute when surgeons deem patients with acute cholecystitis cholecystitis is not present, the PC cohort is likely to be unsuitable for surgery. That said, what evidence to suffer low rates of clinical success compared with is available to assist in the decision to apply this the surgically treated cohort. treatment option? 4. Review articles disguised as high-power studies amassing large patient populations produce deceptive results with little clinical applicability because they CHOLECYSTOSTOMY AS A TEMPORIZING summarize a series of patient populations lacking MEASURE precisely controlled and well-defined descriptors for Most authors still describe PC as a temporizing measure clinical presentation and clinical response. The clin- prior to the definitive open or laparoscopic cholecystec- ical benefit of a retrospective study of retrospective, tomy. This application is most appropriate in patients uncontrolled studies does not change if the patient with acute calculous cholecystitis. For calculous chole- population numbers 1000 or 10,000. cystitis in otherwise healthy, stable patients, surgical resection of the gallbladder remains the first-line and To illustrate these problems, a review3 by sur- definitive treatment option, and patients who happen to geons of 53 studies comprising 1918 patients identified undergo cholecystostomy as a temporizing measure no randomized, controlled studies comparing the out- usually undergo interval cholecystectomy after resolution comes of PC and cholecystectomy in elderly or critically because of an unacceptable risk of recurrence. Even if ill patients with acute cholecystitis. This painstaking resolution of cholecystitis can be achieved and patency of review calculated a 30-day mortality of 15.4% in patients the cystic duct reestablished, recurrence rates after cal- treated with PC and only 4.5% in those going directly to culous cholecystitis range from 10 to 20%5 within the cholecystectomy, though such a comparison was empha- first few years. The utility of cholecystostomy with sized in the final analysis as ‘‘not appropriate’’ based on adjunctive treatments to reduce the risk of recurrence the inadequate literature carefully outlined in the review. (addressed below) has yet to be fully established in I would suggest the following interpretation: Of the PC quality, long-term studies. In low-risk patients, pub- patients that ultimately underwent cholecystectomy, lished periprocedural mortality rates of both open and 15.4% died, but because this patient cohort usually fell laparoscopic cholecystectomy are typically below 1%,6 under the description of unacceptably high-risk for further establishing the one-step, definitive surgical surgery in the acute setting, it should be assumed that option as a better option than prolonged catheterization the mortality rate of acute cholecystectomy would have after cholecystostomy. been much higher. Interestingly, although the afore- For acute calculous cholecystitis in patients who mentioned review is authored by surgeons and falls short are elderly, unstable, critically ill or suffering from severe of finding a well-substantiated indication for PC over comorbidities, the mortality rate of open cholecystec- cholecystectomy in the acute setting, in actual clinical tomy under general anesthesia approaches 20%.7 For this practice, the surgeons themselves are the driving force delicate patient population, PC with interval cholecys- for the popularity of PC because they often control the tectomy or PC with adjunctive therapies such as stone decision to either perform cholecystectomy or defer removal and gallbladder ablation are likely to remain patients to PC. They must perceive an advantage for important options in the treatment algorithm.8 446 SEMINARS IN INTERVENTIONAL RADIOLOGY/VOLUME 28, NUMBER 4 2011 CHOLECYSTOSTOMY AS A DEFINITIVE without adjunctive therapies has been described as a TREATMENT first-line and definitive treatment. The availability of If surgical options under general anesthesia can be such therapies may sway the decision toward PC in select avoided by a fast, simple, low-risk procedure under cases. They include percutaneous stone removal, gall- conscious sedation in any patient, it stands to reason bladder ablation, and gallbladder aspiration. Patients that that procedure should become the new primary with gallbladder rupture and pericholecystic abscess are treatment option. Controversy and confusion over the not considered candidates for these therapies. application of PC raises a key question: Does the exist- ing, albeit insufficient, literature support the potential application of PC as a first-line and potentially definitive therapy for any cases of acute cholecystitis? With randomized, controlled trials, the treatment algorithm will likely evolve, but a review of the limited current literature suggests that there is the greatest support for PC as a first-line, definitive treatment in many patients with acalculous cholecystitis, less support in elderly patients, permanently comorbid patients or critically ill patients with acute calculous cholecystitis, and the least support in otherwise healthy, stable patients with acute calculous cholecystitis. In the case of acalculous cholecystitis, if the cholecystitis as well as the acute, predisposing clinical conditions leading to its manifestation resolve, the cholecystostomy tube can be removed without the need for elective interval cholecystectomy in most cases. The question of whether or not to perform interval cholecys- tectomy depends on the risk of recurrence, which, though not adequately determined, is likely to be low based on the current literature. Chung et al retrospec- tively reviewed 57 patients undergoing PC for acute acalculous cholecystitis and found that of the 49% managed nonoperatively and followed over a median period of 32 months, only 7% of the nonoperative group recurred.9 This result raises the possibility that perform- ance of elective cholecystectomy is often not worth the risk in a patient population that tends toward multiple, long-term systemic comorbidities. In patients with calculous cholecystitis for whom cholecystectomy is likely to remain contraindicated indefinitely, authors have described permanent external drainage or the application of therapies described in the next section. Included in this category are many pa- tients with nonoperable malignant obstruction of the cystic duct, high-risk elderly patients, and patients with critical illnesses and multiple comorbidities. In such patients, the choice of cholecystostomy versus chole- Figure 1 (A) Axial, contrast-enhanced computed tomogra- cystectomy in the acute setting is made by estimating phy image shows a cholecystostomy drain coiled within the the risks of the two interventions on a case-by-case gallbladder (large arrow). The radiopaque marker indicating the basis. position of the most peripheral sidehole (small arrow) has been inadvertently retracted to the peritoneum, and a large bile leak has developed in the right perihepatic space (arrow- head). Note that this catheter was placed via a transperitoneal ADJUNCTIVE AND ASSOCIATED window, which may reduce catheter stability. (B) Coronal THERAPIES reconstruction shows bile extending from the subdiaphrag- Some authors have argued for the application of PC in matic space to the pelvis (arrowhead). Gas in the subdiaph- patients who are likely to remain poor surgical candi- ragmatic space (arrow) indicated superinfection in this patient dates indefinitely. In such cases, cholecystostomy with or who presented with sepsis and peritonitis.  EVALUATING THE CONTROVERSIAL ROLE OF CHOLECYSTOSTOMY IN CURRENT CLINICAL PRACTICE/LORENZ 447 Stone Removal may limit the future of this option as a definitive Authors have employed the cholecystostomy tract to treatment. facilitate removal of gallstones by basket extraction,10,11 dissolution with bile acids, and/or destruction and retrieval with shock-wave lithotripsy.12,13 Retrospec- Gallbladder Ablation tive studies have demonstrated a gallstone recurrence A combination of thermal ablation of the cystic duct and rate of
10 to 30% per year and a symptomatic chemical ablation of the gallbladder lumen have been recurrence rate requiring repeat treatment of
6 to described to treat patients at high risk for complications 18% per year. Stone removal can be repeated as needed, of surgery. Xu et al described small-bore cholecystostomy but the high rate of symptomatic recurrence and the followed by microwave ablation of the cystic duct and risks and consequences of recurrent acute cholecystitis chemical ablation of the gallbladder lumen by infusion of Figure 2 (A) This fluoroscopic image was obtained immediately after percutaneous cholecystectomy for acute acalculous cholecystitis. The catheter is positioned correctly (arrow). (B) The patient was referred back to interventional radiology for worsening fevers and abdominal pain. The catheter is kinked (arrow). (C) Axial, noncontrast computed tomography image shows that the tube does not pass through liver parenchyma, which may reduce its stability. 448 SEMINARS IN INTERVENTIONAL RADIOLOGY/VOLUME 28, NUMBER 4 2011 Figure 3 (A) Prior to catheter removal, one should obtain a fluoroscopic image showing contrast opacification of the cystic duct (arrow) and common bile duct (arrowhead) and free spillage of contrast into the small bowel. (B) An over-the-wire tractogram is usually obtained to verify the presence of an intact tract (arrow) to prevent bile leakage and peritonitis. 95% ethanol14 in 34 patients. Ethanol infusion for 30- clinical outcomes of the acute cholecystitis but a higher minute intervals was repeated every 4 hours eight times. complication rate for PC. However, unlike gallbladder In this retrospective study, mean follow-up was 9 years ablation or gallstone removal, gallbladder aspiration still and the long-term clinical success without recurrence was fails to offer a protracted solution to address the high 85.3%. Future corroboration of these results in random- recurrence rates of acute calculous cholecystitis, a life- ized, controlled trials would suggest a place for ablation as threatening condition. a primary, definitive treatment in high-risk patients with calculous cholecystitis. COMPLICATIONS OF CHOLECYSTOSTOMY Gallbladder Aspiration Major periprocedural complications include sepsis, hem- Some interventional radiologists have advocated gall- orrhage, abscess, peritonitis, transgression of intervening bladder aspiration over PC for the treatment of acute structures such as the colon, and death.2 Studies of cholecystitis. Theoretically, the success of aspiration is patients with the poorest clinical status demonstrate an dependent on two assumptions: the gallbladder cannot incidence of up to 2 to 3% for each of these complications, refill after drainage (a ball-valve obstruction is not but other studies report lower rates that compare favorably present) and adequate drainage is achievable. Ito et al with surgical alternatives in the setting of acute cholecys- prospectively randomized patients with severe acute titis in critically ill patients with multiple comorbidities. cholecystitis to either PC (n ¼ 30) or gallbladder aspira- Major postprocedural complications include inadvertent tion with a 21-gauge needle (n ¼ 27) and obtained good catheter dislodgment or removal resulting in repeat PC, clinical response in 90% of PC patients versus 61% of surgery, or death (