- Email: [email protected]
Percutaneous cholecystostomy in critically ill patients with acute cholecystitis: Complications and late outcome
Clinical Radiology 69 (2014) e247ee252
Contents lists available at ScienceDirect
Clinical Radiology journal homepage: www.clinicalradiologyonline.net
Percutaneous cholecystostomy in critically ill patients with acute cholecystitis: Complications and late outcome E. Atar a, c, G.N. Bachar a, *, c, S. Berlin a, C. Neiman a, E. Bleich-Belenky a, S. Litvin a, M. Knihznik a, A. Belenky a, E. Ram b a
Units of Vascular and Interventional Radiology, Department of Diagnostic Radiology, Rabin Medical Center, Hasharon and Beilinson Hospitals, Petach Tikva, Israel b Department of Surgery, Rabin Medical Center, Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
art icl e i nformat ion Article history: Received 13 October 2013 Received in revised form 8 January 2014 Accepted 14 January 2014
AIM: To evaluate the outcome of percutaneous cholecystostomy in critically ill patients with acute cholecystitis. MATERIALS AND METHODS: The study group included critically ill patients who underwent percutaneous cholecystostomy for acute cholecystitis at a tertiary medical centre in 2007 e2011. Data on complications, morbidities, surgical outcome, and imaging findings were collected from the medical files and radiology information system. RESULTS: There were 48 women (59.3%) and 33 men (40.7%), with a median age of 82 years (range 47e99 years). Seventy-one (88%) had calculous cholecystitis and 10 (12%), acalculous cholecystitis. The drain was successfully inserted in all cases with no immediate major procedural complications. Fifteen patients (18.5%) died in-hospital within 30 days, mainly (93%) due to septic shock (14/15), another 20 patients (24.7%) died during the study period of unrelated co-morbidities. Of the remaining 46 patients, 36 (78.2%) had surgical cholecystectomies. In patients with acalculous cholecystitis, the drain was removed after cessation of symptoms. Transcystic cholangiography identified five patients with additional stones in the common bile duct. They were managed by pushing the stones into the duodenum via the cystostomy access, sparing them the need for surgical exploration. CONCLUSIONS: Early percutaneous gallbladder drainage is safe and effective in critically ill patients in the acute phase of cholecystitis, with a high technical success rate. Surgical results in survivors are better than reported in patients treated surgically without drainage. Bile duct stones can be eliminated without creating an additional access. Ó 2014 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Introduction * Guarantor and correspondent: G.N. Bachar, Department of Radiology, Rabin Medical Center, Petach Tikva 49100, Israel. Tel.: þ972 3 937 2219; fax: þ972 3 937 2550. E-mail address: [email protected] (G.N. Bachar). c Drs Atar and Bachar contributed equally to this study.
Acute cholecystitis is one of the most frequent reasons for emergency admission to general surgical services. Elderly persons account for 50e70% of cases. The main cause (>90% of cases) is obstruction of the cystic duct or neck of the gallbladder by gallstones.1 Most patients are
0009-9260/$ e see front matter Ó 2014 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.crad.2014.01.012
e248
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
admitted with acute calculous cholecystitis; acute acalculous cholecystitis generally occurs as a complication of a pre-existing critical illness.2 The reference standard of treatment of acute cholecystitis in low-risk patients is laparoscopic cholecystectomy, which carries a 0.8% mortality risk. However, the rate rises to 50% in older patients, especially those who are critically ill.2e4 Therefore, in highrisk cases, the administration of antibiotic therapy and hydration is often recommended in the acute phase followed by elective cholecystectomy.5,6 In severely septic patients, this approach is unfeasible, and gallbladder drainage via a cholecystostomy tube is necessary. Percutaneous cholecystostomy (PC) is a minimally invasive procedure usually performed in an interventional radiology suite or at bedside in the intensive care unit (ICU) under local anaesthesia with real-time imaging guidance. It was first described by Radder7 as an alternative to conservative treatment with antibiotics or to immediate open or laparoscopic cholecystectomy; the reported mortality rate was <2%.8 It may be used as a temporary “bridge” to surgery because of the high (19%) recurrence rate of cholecystitis.9,10 In patients with acute calculous cholecystitis, particularly critically ill patients, it may serve as the definitive treatment or at least as a means to eliminate the need for further highrisk interventions, such as endoscopic retrograde cholangiopancreatography or surgical exploration of the common bile duct. Although several studies have assessed the usefulness of PC, none referred to the possibility of further treatment of stone impaction via the cholecystostomy drain. Hence, there are no uniform guidelines to identify patients who may benefit from early PC. Moreover, the possibility of using the cholecystostomy drain access for further treatment of stone impaction has not been systematically investigated. The aim of the present study was to evaluate the morbidity, mortality, and long-term outcome of critically ill patients with acute calculous or acalculous cholecystitis after early insertion of a cholecystostomy drain. A further aim was to determine whether bile duct stones could be eliminated via the percutaneous access without the need to create an additional access.11
Materials and methods Patients and setting A retrospective study design was used. The study group included 81 consecutive critically ill patients with acute cholecystitis from four surgical departments of a major tertiary medical centre, who underwent urgent biliary drainage via a PC in the hospital’s Unit of Vascular and Interventional Radiology during 2007e2010. The study was approved by the Institutional Review Board. The diagnosis of acute cholecystitis was based on the medical history and clinical signs: positive Murphy’s sign, fever, pain in the right upper quadrant, and laboratory and imaging findings. Criteria for sonographic diagnosis were one of the following: positive sonographic Murphy’s sign,
enlargement of the anteroposterior gallbladder axis by >10 cm, diameter >5 cm, gallbladder wall thickening of >3 mm, loculated pericholecystic fluid, hazy delineation of the gallbladder wall, striated wall thickening, and the presence of pericystic fluid collection. Criteria for a computed tomography (CT) diagnosis were gallbladder distention with wall thickening of >3 mm, presence of pericholecystic fluid, haziness of pericholecystic fat, increased attenuation of bile, and increased gallbladder wall attenuation (on contrast-enhanced imaging). Sepsis was defined as infection causing hypotension and warranting colloid or catecholamine support, and/or one or more dysfunctional organs.12 All patients were considered to be at high anaesthetic or surgical risk because of the combination of poor septic state, irresponsiveness to conservative management, and complex co-morbidities, as defined by the American Society of Anesthesiologists (ASA).
Procedure All patients were admitted with sepsis due to acute cholecystitis. According to the departmental protocol, they were seen primarily by a surgeon and immediately transferred to the ICU for standard resuscitation with fluid, catecholamine support, and administration of intravenous broad-spectrum antibiotics. Owing to the absence of clinical improvement within a few hours, the need for percutaneous gallbladder drainage was determined by a multidisciplinary team of surgeons, anaesthesiologists, intensivists, and interventional radiologists. Coagulopathies were corrected before the procedure to maintain the international normalized ratio (INR) <1.5 and the platelet count >50 109/l. All patients had an ASA score of >3 when the procedure was performed. Although the exact time of the request for gallbladder drainage was not known in all cases, the policy was to perform drainage as soon as possible, and always on the same day as the request, including after working hours drainage by on-call staff. After providing informed consent, patients underwent percutaneous drainage by placement of a cholecystostomy tube under local anaesthesia, either in the ICU or in the interventional radiology suite. The procedure was performed by a qualified interventional radiologist using an aseptic technique with either CT or, usually, real-time ultrasound guidance. Vital signs including blood pressure, pulse, and oxygenation status were monitored throughout the procedure. Gallbladder puncture was directed through a transhepatic route to reduce the risk of bile leakage into the peritoneum. A 21 F Chiba needle (Cook, Bloomington, IN, USA) was advanced under real-time sonographic guidance into the gallbladder, and bile was aspirated and cultured. The Seldinger technique was used, wherein the needle was exchanged over a 0.01800 guide wire to a Neff set (Cook) and over a 0.03800 guide wire. After dilatation of the newly created tract, an 8.3 or 10 F multipurpose drain was inserted (Cook). First fluid aspirated (either through the Chiba
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
needle or after changing to the Neff set, depending on bile viscosity) was sent for culture, and closed system drainage with a 20 ml syringe via a three-way stopcock was performed until almost complete manual evacuation, as verified sonographically. When the procedure was performed under CT guidance, the same equipment and technique were used. A few days after the patient stabilized and biliary symptoms ceased, transcystic cholangiography was performed to assess the presence/absence of cystic duct stones and passage into the biliary tree and to search for common bile duct stones. If stones were detected, patients were transferred to the interventional radiological suite, and the stones were eliminated via the papilla through the access afforded by the cystostomy drain, using the method described previously.11 In brief, following balloon dilatation of the papilla to a diameter equal to that of the largest stone, the stones were pushed over a stiff guide wire into the duodenum, and a biliary drain was placed for control for repeated cholangiographic verification of the common bile duct until surgical resection of the gallbladder. In all treated patients, no complications, such as bleeding, bile perforation, or pancreatitis were encountered.11 Major complications were defined as any procedurerelated morbidity requiring either radiological or emergency surgical intervention. Mortality was defined as any death occurring during the procedure and up to 30 days thereafter. A positive response was defined as an improvement in clinical signs (reduction of abdominal tenderness, fever, and leukocytosis) within 12 h after the procedure. In patients with stones only within the gallbladder, the policy was to leave the drain in place until the cholecystectomy was performed.
Data collection and analysis Data on demographics, clinical and surgical parameters, laboratory tests, bacterial cultures, and imaging findings were obtained from the clinical medical records and the institute’s radiology information system. The SPSS 16.0 statistical software package was used for data analysis. Categorical values were expressed as percentages. Continuous variables were expressed as means and standard deviations, medians and ranges.
Results The study group consisted of 48 women (59.3%) and 33 men (40.7%) of median age 82 years (range 47e99 years). All had complex co-morbidities (Table 1). Sixty patients (74%) presented to the emergency department with signs and symptoms of acute cholecystitis and 21 (26%) acquired acute cholecystitis during hospitalization. The average length of time from onset of symptoms to initiation of precholecystostomy antibiotic treatment was 20 h (range 2 h to 3 days). The average interval from symptom onset to catheter drainage was 2 days (range 6 h to 4 days). PC was technically successful in all patients, with no major procedure-related complications. One patient had
e249
Table 1 Comorbidities in 81 patients with acute cholecystitis. Comorbidity
n (%)
Cardiovascular disease Advanced renal disease Pancreatitis General debility Liver disease Immunosuppression Diabetes
50 21 2 7 10 5 58
(61.7%) (25.9%) (2.4%) (8.6%) (12.3%) (6.1%) (71.6%)
mild procedure-related bleeding from the upper gastrointestinal tract, which was conservatively treated with blood transfusion, with good response. There was no documentation of intraperitoneal or external bile leakage. Five demented patients pulled out the cholecystostomy drain during their hospital stay, and a new drain was successfully inserted. In 64 patients (79%), the abdominal pain resolved with a reduction in fever and leukocytosis within 3 days of PC. In 10 patients (12%) with acalculous cholecystitis in whom the drain was closed for 48 h and when symptoms did not recur, the tube was removed. In another five patients with calculous cholecystitis, cholangiography revealed common bile duct stones additionally to the gallbladder stones, and they were eliminated in a second procedure via the papilla through the cholecystostomy drain access, as described previously11 (Fig 1). In two patients (2.5%), the clinical status did not improve after gallbladder drainage, and they required emergency cholecystectomy. Reasons were additional stones impacted in the common bile duct in one patient and gangrenous cholecystitis, noted during subsequent surgery, in the other. Fifteen patients (18.5%) died within 30 days of the procedure, 14 (93%) of septic shock and one (7%) of pancreatitis. Twenty patients died from co-morbidities during the study period in spite of bile drainage. Nevertheless, a temporary response to the drainage reflecting a temperature increase (in shock patients) or decrease (in patients with high fever), improvement in blood pressure and general status was documented. Of the total 46 survivors, 36 (78%) underwent surgical cholecystectomies: laparoscopic in 32 (converted to open surgery in one because of adhesions), and open in three. One patient (2.8%) died of post-surgical sepsis and two (5.6%) had complications of small bowel obstruction, which resolved with conservative treatment, and transient pulmonary oedema treated conservatively. Ten patients (12.3%) had no gallbladder stones and did not require further intervention. Their bile drain was removed during the hospital stay. Fig 2 summarizes the overall outcome of patients who underwent cholecystostomy in the present study. Bile cultures were obtained in all patients. Results were positive in 63 patients (77.7%); more than one pathogen was found in 18 patients. Specifically, Gram-negative bacilli were identified in 65 patients (80.2%), Staphylococcus species in five (6.1%), Enterococcus in three (3.7%), other Grampositive species in three (3.7%), and fungi in five (6.1%).
e250
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
Figure 1 A 60-year-old man with acute cholecystitis who underwent insertion of a cholecystostomy tube. (a) Cholangiographic follow-up demonstrates three stones in the CBD. (b) Guidewire inserted via the gallbladder through the cholecystostomy tube tract, into the duodenum. (c) Balloon dilatation of the papilla (8 40 mm), equals the diameter of the largest stone. (d) After dilatation, the balloon was deflated and then re-inflated proximal to the stones and the stones were pushed into the duodenum. Control cholangiography verifies the elimination of the stones. (e) An 8 F biliary drain was left in place until cholangiographic follow-up and drain removal, prior to cholecystectomy.
The average length of the initial hospital stay was 21 days (range 7e96 days), and the average follow-up time was 4 months (range 3 weeks to 3 years). The average interval from drainage to elective cholecystectomy was 3
months (range 3 weeks to 8 months) and the drains were removed during surgery. No records of site infection or complications related to the drain were found in the medical records.
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
e251
Figure 2 The overall outcome of patients who underwent cholecystostomy.
Discussion This retrospective study assessed the outcome of percutaneous gallbladder drainage in critically ill patients with acute cholecystitis. Acute cholecystitis is a common disease that may lead to complications, such as empyema, gangrene, perforation, bile leakage, pericholecystitis with abscess formation, peritonitis, sepsis, and death. The incidence increases with age and those who also have a higher proportion of systemic comorbidities. PC was first reported by Radder7 in 1980, who successfully treated a patient with empyema of the gallbladder by percutaneous drainage. It is gaining acceptance as a less invasive alternative to open procedures for acute cholecystitis13e18 or a temporary means to relieve symptoms until interval cholecystectomy, particularly in patients who are critically ill or otherwise unsuitable for urgent cholecystectomy.8,19e24 Its use is based on the assumption that initial drainage of the gallbladder leads to acute decompression of the biliary system with subsequent resolution of gallbladder inflammation. Other advantages include bedside applicability, local anaesthesia,25 and lower complication rates than urgent cholecystectomy (3e13%).13e18 It spares patients with acalculous cholecystitis the need for surgery. It also makes it possible to perform diagnostic cholangiography to study the biliary system, and serves as an access for intervention to eliminate common bile duct stones, if necessary.11 The draining
catheter can stay in place until cholecystectomy is performed,23 although this practice is controversial. In the present study, urgent PC was performed in 81 critically ill patients with acute cholecystitis, 71 (88%) calculous and 10 (12%) acalculous. All were considered poor candidates for surgery because of the severity of their illness and the presence of serious comorbidities. In addition, all failed to clinically respond to treatment with fluids, catecholamine support, and intravenous broad-spectrum antibiotics administered immediately after diagnosis. In order to stop the clinical deterioration in these complicated patients caused by the bile occlusion, the policy was (and remains) to decompress the gallbladder as soon as possible, always on the same day and before antibiotic and fluids treatment became effective, with the view that immediate, direct treatment for the cause of deterioration would improve chances of survival. There is, as yet, no consensus on the value of PC as a definitive treatment. Griniatsos et al.,21 in a study of 24 elderly patients, reported control of acute cholecystitis with cholecystostomy in 90% of 24 elderly patients and recommended against interval cholecystectomy. However, Ha et al.22 found that patients with acute cholecystitis treated by cholecystostomy drainage without interval cholecystectomy had a high (46%) 3-year recurrence rate. Joseph et al.26 observed that the outcome after PC was better when acute cholecystitis was the primary illness and was not precipitated by a concurrent illness. In their study, patients who
e252
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
presented to the emergency department fared better (84%) than inpatients (34%). Patients with sepsis had the worst outcome overall. The authors also found that long-term outcome was better when cholecystectomy was performed later. Melloul et al.,24 in a study of 23 patients with acute cholecystitis, reported that the complication rate was low after percutaneous drainage but surgery was associated with significantly increased perioperative morbidity. Furthermore, after PC, 11% of patients underwent common bile duct stone elimination through the route created by cholecystostomy, thereby avoiding endoscopic retrograde cholangiopancreatography and surgical exploration of the common bile duct. The success rate in this subgroup was 100%, with no morbidity and zero fatalities. In the patients with acalculous cholecystitis (12% of patients), surgery was avoided altogether and the drain was removed when the infection subsided. In the present study of a critically ill, high-risk population, PC proved to be a safe option, with a technical success rate of 100%. The 18% in-hospital 30-day mortality rate was attributable mainly to the poor medical condition of the patients. Similar to the study of Melloul et al.,24 additional common bile duct stones were effectively eliminated through the cholecystostomy access. All patients with calculous cholecystitis who survived PC underwent cholecystectomy, with a generally satisfactory outcome. The post-surgery morbidity rate was 5.6% compared to 2.8e15% in the medical literature, and the mortality rate was 2.8% compared to 5.6e18% in the literature.7 These findings suggest that scheduled cholecystectomy after PC may prevent biliary complications over the long term. Currently, there are no clear guidelines for selecting patients who may benefit from PC over urgent cholecystectomy, and the decision relies mainly on clinical judgment. The ongoing retrospective, controlled Chocolate study is assessing which treatment modality is best suited for critically ill patients, but it does not include critically ill patients with acalculous cholecystitis. The main strength of the present study is the large sample size. To the authors’ knowledge, this is the largest such series to date published in the English language medical literature. The main limitations of the study are its retrospective design and its restriction of the study population to a single medical centre. Moreover, there was no control group, and patients were not blinded to their treatment. Further studies are needed to corroborate and expand the present findings. Nevertheless, given the high technical success rates and good outcomes of the procedures, early percutaneous gallbladder drainage has a place in the early management of acute cholecystitis in critically ill patients.
References 1. Hirota M, Takada T, Kawarada Y, et al. Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg 2007;14:78e82.
2. Laurila J, Syrjala H, Laurila PA, et al. Acute acalculous cholecystitis in critically ill patients. Acta Anaesthesiol Scand 2004;48:986e91. 3. Steiner CA, Bass EB, Talamini MA, et al. Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland. N Engl J Med 1994;330:403e8. 4. Wiseman JT, Sharuk MN, Singla A, et al. Surgical management of acute cholecystitis at a tertiary care center in the modern era. Arch Surg 2010;145:439e44. 5. Kum CK, Eypasch E, Lefering R, et al. Laparoscopic cholecystectomy for acute cholecystitis: is it really safe? World J Surg 1996;20:43e8. 6. Kiviluoto T, Siren J, Luukkonen P, et al. Randomized trial of laparoscopic vs open cholecystectomy for acute and gangrenous cholecystitis. Lancet 1998;351:321e5. 7. Radder RW. Ultrasonically guided percutaneous catheter drainage for gallbladder empyema. Diagn Imaging 1980;49:330e3. 8. Winbladh A, Gullstrand P, Svanvik J, et al. Systematic review of cholecystostomy as a treatment option in acute cholecystitis. HPB (Oxford) 2009;11:183e93. 9. Elyaderani M, Gabriele OF. Percutaneous cholecystostomy and cholangiography in patients with obstructive jaundice. Radiology 1979;130:601e2. 10. Koebrugge B, van Leuken M, Ernst MF, et al. Percutaneous cholecystostomy in critically ill patients with a cholecystitis: a safe option. Dig Surg 2010;27:417e21. 11. Atar E, Neiman C, Ram E, et al. Percutaneous transpapillary elimination of common bile duct stones utilizing existent gallbladder drain for access. Isr Med Assoc J 2012;14:1e4. 12. Lever A, Mackenzie I. Sepsis: definition, epidemiology, and diagnosis. Br Med J 2007;335:879e83. 13. Edlund G, Ljugdahl M. Acute cholecystitis in the elderly. Am J Surg 1990;159:414e6. 14. Margiotta SJ, Willis IH, Wallack MD. Cholecystectomy in the elderly. Am Surg 1988;54:34e9. 15. Lujan JA, Parilla P, Robles R, et al. Laparoscopic cholecystectomy vs open cholecystectomy in the treatment of acute cholecystitis: a prospective study. Arch Surg 1998;133:173e5. 16. Patel M, Miedema BW, James MA, et al. Percutaneous cholecystostomy is an effective treatment for high-risk patients with acute cholecystitis. Am Surg 2000;66:33e7. 17. Eldar S, Sabo E, Nash E, et al. Laparoscopic cholecystectomy for the various types of gallbladder inflammation: a prospective trial. Surg Laparosc Endosc 1998;8:200e7. 18. Berber E, Engle KL, String A, et al. Selective use of tube cholecystostomy with interval laparoscopic cholecystectomy in acute cholecystitis. Arch Surg 2000;135:341e6. 19. Schwesinger WH, Sirinek KR, Strodel WE. Laparoscopic cholecystectomy for biliary tract emergencies: state of the art. World J Surg 1999;33:334e42. 20. Ginat D, Saad WE. Cholecystostomy and transcholecystic biliary access. Tech Vasc Interv Radiol 2008;11:2e13. 21. Griniatsos J, Petrou A, Pappas P, et al. Percutaneous cholecystostomy without interval cholecystectomy as definitive treatment of acute cholecystitis in elderly and critically ill patients. South Med J 2008;101:586e90. 22. Ha JP, Tsui KK, Tang CN, et al. Cholecystectomy or not after percutaneous cholecystostomy for acute calculous cholecystitis in high-risk patients. Hepatogastroenterol 2008;55:1497e502. 23. Morse BC, Smith JB, Lawdahl RB, et al. Management of acute cholecystitis in critically ill patients: contemporary role for cholecystostomy and subsequent cholecystectomy. Am Surg 2010;76:708e12. 24. Melloul E, Denys A, Demartines N, et al. Percutaneous drainage versus emergency cholecystectomy for the treatment of acute cholecystitis in critically ill patients: does it matter? World J Surg 2011;35:826e33. 25. Holzheimer RG, Mannick JA, editors. Surgical treatment: evidence-based and problem-oriented. Munich: Zuckschwerdt; 2001. 26. Joseph T, Unver K, Hwang GL, et al. Percutaneous cholecystostomy for acute cholecystitis: ten-year experience. J Vasc Interv Radiol 2012;23:83e8.
Contents lists available at ScienceDirect
Clinical Radiology journal homepage: www.clinicalradiologyonline.net
Percutaneous cholecystostomy in critically ill patients with acute cholecystitis: Complications and late outcome E. Atar a, c, G.N. Bachar a, *, c, S. Berlin a, C. Neiman a, E. Bleich-Belenky a, S. Litvin a, M. Knihznik a, A. Belenky a, E. Ram b a
Units of Vascular and Interventional Radiology, Department of Diagnostic Radiology, Rabin Medical Center, Hasharon and Beilinson Hospitals, Petach Tikva, Israel b Department of Surgery, Rabin Medical Center, Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
art icl e i nformat ion Article history: Received 13 October 2013 Received in revised form 8 January 2014 Accepted 14 January 2014
AIM: To evaluate the outcome of percutaneous cholecystostomy in critically ill patients with acute cholecystitis. MATERIALS AND METHODS: The study group included critically ill patients who underwent percutaneous cholecystostomy for acute cholecystitis at a tertiary medical centre in 2007 e2011. Data on complications, morbidities, surgical outcome, and imaging findings were collected from the medical files and radiology information system. RESULTS: There were 48 women (59.3%) and 33 men (40.7%), with a median age of 82 years (range 47e99 years). Seventy-one (88%) had calculous cholecystitis and 10 (12%), acalculous cholecystitis. The drain was successfully inserted in all cases with no immediate major procedural complications. Fifteen patients (18.5%) died in-hospital within 30 days, mainly (93%) due to septic shock (14/15), another 20 patients (24.7%) died during the study period of unrelated co-morbidities. Of the remaining 46 patients, 36 (78.2%) had surgical cholecystectomies. In patients with acalculous cholecystitis, the drain was removed after cessation of symptoms. Transcystic cholangiography identified five patients with additional stones in the common bile duct. They were managed by pushing the stones into the duodenum via the cystostomy access, sparing them the need for surgical exploration. CONCLUSIONS: Early percutaneous gallbladder drainage is safe and effective in critically ill patients in the acute phase of cholecystitis, with a high technical success rate. Surgical results in survivors are better than reported in patients treated surgically without drainage. Bile duct stones can be eliminated without creating an additional access. Ó 2014 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Introduction * Guarantor and correspondent: G.N. Bachar, Department of Radiology, Rabin Medical Center, Petach Tikva 49100, Israel. Tel.: þ972 3 937 2219; fax: þ972 3 937 2550. E-mail address: [email protected] (G.N. Bachar). c Drs Atar and Bachar contributed equally to this study.
Acute cholecystitis is one of the most frequent reasons for emergency admission to general surgical services. Elderly persons account for 50e70% of cases. The main cause (>90% of cases) is obstruction of the cystic duct or neck of the gallbladder by gallstones.1 Most patients are
0009-9260/$ e see front matter Ó 2014 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.crad.2014.01.012
e248
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
admitted with acute calculous cholecystitis; acute acalculous cholecystitis generally occurs as a complication of a pre-existing critical illness.2 The reference standard of treatment of acute cholecystitis in low-risk patients is laparoscopic cholecystectomy, which carries a 0.8% mortality risk. However, the rate rises to 50% in older patients, especially those who are critically ill.2e4 Therefore, in highrisk cases, the administration of antibiotic therapy and hydration is often recommended in the acute phase followed by elective cholecystectomy.5,6 In severely septic patients, this approach is unfeasible, and gallbladder drainage via a cholecystostomy tube is necessary. Percutaneous cholecystostomy (PC) is a minimally invasive procedure usually performed in an interventional radiology suite or at bedside in the intensive care unit (ICU) under local anaesthesia with real-time imaging guidance. It was first described by Radder7 as an alternative to conservative treatment with antibiotics or to immediate open or laparoscopic cholecystectomy; the reported mortality rate was <2%.8 It may be used as a temporary “bridge” to surgery because of the high (19%) recurrence rate of cholecystitis.9,10 In patients with acute calculous cholecystitis, particularly critically ill patients, it may serve as the definitive treatment or at least as a means to eliminate the need for further highrisk interventions, such as endoscopic retrograde cholangiopancreatography or surgical exploration of the common bile duct. Although several studies have assessed the usefulness of PC, none referred to the possibility of further treatment of stone impaction via the cholecystostomy drain. Hence, there are no uniform guidelines to identify patients who may benefit from early PC. Moreover, the possibility of using the cholecystostomy drain access for further treatment of stone impaction has not been systematically investigated. The aim of the present study was to evaluate the morbidity, mortality, and long-term outcome of critically ill patients with acute calculous or acalculous cholecystitis after early insertion of a cholecystostomy drain. A further aim was to determine whether bile duct stones could be eliminated via the percutaneous access without the need to create an additional access.11
Materials and methods Patients and setting A retrospective study design was used. The study group included 81 consecutive critically ill patients with acute cholecystitis from four surgical departments of a major tertiary medical centre, who underwent urgent biliary drainage via a PC in the hospital’s Unit of Vascular and Interventional Radiology during 2007e2010. The study was approved by the Institutional Review Board. The diagnosis of acute cholecystitis was based on the medical history and clinical signs: positive Murphy’s sign, fever, pain in the right upper quadrant, and laboratory and imaging findings. Criteria for sonographic diagnosis were one of the following: positive sonographic Murphy’s sign,
enlargement of the anteroposterior gallbladder axis by >10 cm, diameter >5 cm, gallbladder wall thickening of >3 mm, loculated pericholecystic fluid, hazy delineation of the gallbladder wall, striated wall thickening, and the presence of pericystic fluid collection. Criteria for a computed tomography (CT) diagnosis were gallbladder distention with wall thickening of >3 mm, presence of pericholecystic fluid, haziness of pericholecystic fat, increased attenuation of bile, and increased gallbladder wall attenuation (on contrast-enhanced imaging). Sepsis was defined as infection causing hypotension and warranting colloid or catecholamine support, and/or one or more dysfunctional organs.12 All patients were considered to be at high anaesthetic or surgical risk because of the combination of poor septic state, irresponsiveness to conservative management, and complex co-morbidities, as defined by the American Society of Anesthesiologists (ASA).
Procedure All patients were admitted with sepsis due to acute cholecystitis. According to the departmental protocol, they were seen primarily by a surgeon and immediately transferred to the ICU for standard resuscitation with fluid, catecholamine support, and administration of intravenous broad-spectrum antibiotics. Owing to the absence of clinical improvement within a few hours, the need for percutaneous gallbladder drainage was determined by a multidisciplinary team of surgeons, anaesthesiologists, intensivists, and interventional radiologists. Coagulopathies were corrected before the procedure to maintain the international normalized ratio (INR) <1.5 and the platelet count >50 109/l. All patients had an ASA score of >3 when the procedure was performed. Although the exact time of the request for gallbladder drainage was not known in all cases, the policy was to perform drainage as soon as possible, and always on the same day as the request, including after working hours drainage by on-call staff. After providing informed consent, patients underwent percutaneous drainage by placement of a cholecystostomy tube under local anaesthesia, either in the ICU or in the interventional radiology suite. The procedure was performed by a qualified interventional radiologist using an aseptic technique with either CT or, usually, real-time ultrasound guidance. Vital signs including blood pressure, pulse, and oxygenation status were monitored throughout the procedure. Gallbladder puncture was directed through a transhepatic route to reduce the risk of bile leakage into the peritoneum. A 21 F Chiba needle (Cook, Bloomington, IN, USA) was advanced under real-time sonographic guidance into the gallbladder, and bile was aspirated and cultured. The Seldinger technique was used, wherein the needle was exchanged over a 0.01800 guide wire to a Neff set (Cook) and over a 0.03800 guide wire. After dilatation of the newly created tract, an 8.3 or 10 F multipurpose drain was inserted (Cook). First fluid aspirated (either through the Chiba
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
needle or after changing to the Neff set, depending on bile viscosity) was sent for culture, and closed system drainage with a 20 ml syringe via a three-way stopcock was performed until almost complete manual evacuation, as verified sonographically. When the procedure was performed under CT guidance, the same equipment and technique were used. A few days after the patient stabilized and biliary symptoms ceased, transcystic cholangiography was performed to assess the presence/absence of cystic duct stones and passage into the biliary tree and to search for common bile duct stones. If stones were detected, patients were transferred to the interventional radiological suite, and the stones were eliminated via the papilla through the access afforded by the cystostomy drain, using the method described previously.11 In brief, following balloon dilatation of the papilla to a diameter equal to that of the largest stone, the stones were pushed over a stiff guide wire into the duodenum, and a biliary drain was placed for control for repeated cholangiographic verification of the common bile duct until surgical resection of the gallbladder. In all treated patients, no complications, such as bleeding, bile perforation, or pancreatitis were encountered.11 Major complications were defined as any procedurerelated morbidity requiring either radiological or emergency surgical intervention. Mortality was defined as any death occurring during the procedure and up to 30 days thereafter. A positive response was defined as an improvement in clinical signs (reduction of abdominal tenderness, fever, and leukocytosis) within 12 h after the procedure. In patients with stones only within the gallbladder, the policy was to leave the drain in place until the cholecystectomy was performed.
Data collection and analysis Data on demographics, clinical and surgical parameters, laboratory tests, bacterial cultures, and imaging findings were obtained from the clinical medical records and the institute’s radiology information system. The SPSS 16.0 statistical software package was used for data analysis. Categorical values were expressed as percentages. Continuous variables were expressed as means and standard deviations, medians and ranges.
Results The study group consisted of 48 women (59.3%) and 33 men (40.7%) of median age 82 years (range 47e99 years). All had complex co-morbidities (Table 1). Sixty patients (74%) presented to the emergency department with signs and symptoms of acute cholecystitis and 21 (26%) acquired acute cholecystitis during hospitalization. The average length of time from onset of symptoms to initiation of precholecystostomy antibiotic treatment was 20 h (range 2 h to 3 days). The average interval from symptom onset to catheter drainage was 2 days (range 6 h to 4 days). PC was technically successful in all patients, with no major procedure-related complications. One patient had
e249
Table 1 Comorbidities in 81 patients with acute cholecystitis. Comorbidity
n (%)
Cardiovascular disease Advanced renal disease Pancreatitis General debility Liver disease Immunosuppression Diabetes
50 21 2 7 10 5 58
(61.7%) (25.9%) (2.4%) (8.6%) (12.3%) (6.1%) (71.6%)
mild procedure-related bleeding from the upper gastrointestinal tract, which was conservatively treated with blood transfusion, with good response. There was no documentation of intraperitoneal or external bile leakage. Five demented patients pulled out the cholecystostomy drain during their hospital stay, and a new drain was successfully inserted. In 64 patients (79%), the abdominal pain resolved with a reduction in fever and leukocytosis within 3 days of PC. In 10 patients (12%) with acalculous cholecystitis in whom the drain was closed for 48 h and when symptoms did not recur, the tube was removed. In another five patients with calculous cholecystitis, cholangiography revealed common bile duct stones additionally to the gallbladder stones, and they were eliminated in a second procedure via the papilla through the cholecystostomy drain access, as described previously11 (Fig 1). In two patients (2.5%), the clinical status did not improve after gallbladder drainage, and they required emergency cholecystectomy. Reasons were additional stones impacted in the common bile duct in one patient and gangrenous cholecystitis, noted during subsequent surgery, in the other. Fifteen patients (18.5%) died within 30 days of the procedure, 14 (93%) of septic shock and one (7%) of pancreatitis. Twenty patients died from co-morbidities during the study period in spite of bile drainage. Nevertheless, a temporary response to the drainage reflecting a temperature increase (in shock patients) or decrease (in patients with high fever), improvement in blood pressure and general status was documented. Of the total 46 survivors, 36 (78%) underwent surgical cholecystectomies: laparoscopic in 32 (converted to open surgery in one because of adhesions), and open in three. One patient (2.8%) died of post-surgical sepsis and two (5.6%) had complications of small bowel obstruction, which resolved with conservative treatment, and transient pulmonary oedema treated conservatively. Ten patients (12.3%) had no gallbladder stones and did not require further intervention. Their bile drain was removed during the hospital stay. Fig 2 summarizes the overall outcome of patients who underwent cholecystostomy in the present study. Bile cultures were obtained in all patients. Results were positive in 63 patients (77.7%); more than one pathogen was found in 18 patients. Specifically, Gram-negative bacilli were identified in 65 patients (80.2%), Staphylococcus species in five (6.1%), Enterococcus in three (3.7%), other Grampositive species in three (3.7%), and fungi in five (6.1%).
e250
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
Figure 1 A 60-year-old man with acute cholecystitis who underwent insertion of a cholecystostomy tube. (a) Cholangiographic follow-up demonstrates three stones in the CBD. (b) Guidewire inserted via the gallbladder through the cholecystostomy tube tract, into the duodenum. (c) Balloon dilatation of the papilla (8 40 mm), equals the diameter of the largest stone. (d) After dilatation, the balloon was deflated and then re-inflated proximal to the stones and the stones were pushed into the duodenum. Control cholangiography verifies the elimination of the stones. (e) An 8 F biliary drain was left in place until cholangiographic follow-up and drain removal, prior to cholecystectomy.
The average length of the initial hospital stay was 21 days (range 7e96 days), and the average follow-up time was 4 months (range 3 weeks to 3 years). The average interval from drainage to elective cholecystectomy was 3
months (range 3 weeks to 8 months) and the drains were removed during surgery. No records of site infection or complications related to the drain were found in the medical records.
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
e251
Figure 2 The overall outcome of patients who underwent cholecystostomy.
Discussion This retrospective study assessed the outcome of percutaneous gallbladder drainage in critically ill patients with acute cholecystitis. Acute cholecystitis is a common disease that may lead to complications, such as empyema, gangrene, perforation, bile leakage, pericholecystitis with abscess formation, peritonitis, sepsis, and death. The incidence increases with age and those who also have a higher proportion of systemic comorbidities. PC was first reported by Radder7 in 1980, who successfully treated a patient with empyema of the gallbladder by percutaneous drainage. It is gaining acceptance as a less invasive alternative to open procedures for acute cholecystitis13e18 or a temporary means to relieve symptoms until interval cholecystectomy, particularly in patients who are critically ill or otherwise unsuitable for urgent cholecystectomy.8,19e24 Its use is based on the assumption that initial drainage of the gallbladder leads to acute decompression of the biliary system with subsequent resolution of gallbladder inflammation. Other advantages include bedside applicability, local anaesthesia,25 and lower complication rates than urgent cholecystectomy (3e13%).13e18 It spares patients with acalculous cholecystitis the need for surgery. It also makes it possible to perform diagnostic cholangiography to study the biliary system, and serves as an access for intervention to eliminate common bile duct stones, if necessary.11 The draining
catheter can stay in place until cholecystectomy is performed,23 although this practice is controversial. In the present study, urgent PC was performed in 81 critically ill patients with acute cholecystitis, 71 (88%) calculous and 10 (12%) acalculous. All were considered poor candidates for surgery because of the severity of their illness and the presence of serious comorbidities. In addition, all failed to clinically respond to treatment with fluids, catecholamine support, and intravenous broad-spectrum antibiotics administered immediately after diagnosis. In order to stop the clinical deterioration in these complicated patients caused by the bile occlusion, the policy was (and remains) to decompress the gallbladder as soon as possible, always on the same day and before antibiotic and fluids treatment became effective, with the view that immediate, direct treatment for the cause of deterioration would improve chances of survival. There is, as yet, no consensus on the value of PC as a definitive treatment. Griniatsos et al.,21 in a study of 24 elderly patients, reported control of acute cholecystitis with cholecystostomy in 90% of 24 elderly patients and recommended against interval cholecystectomy. However, Ha et al.22 found that patients with acute cholecystitis treated by cholecystostomy drainage without interval cholecystectomy had a high (46%) 3-year recurrence rate. Joseph et al.26 observed that the outcome after PC was better when acute cholecystitis was the primary illness and was not precipitated by a concurrent illness. In their study, patients who
e252
E. Atar et al. / Clinical Radiology 69 (2014) e247ee252
presented to the emergency department fared better (84%) than inpatients (34%). Patients with sepsis had the worst outcome overall. The authors also found that long-term outcome was better when cholecystectomy was performed later. Melloul et al.,24 in a study of 23 patients with acute cholecystitis, reported that the complication rate was low after percutaneous drainage but surgery was associated with significantly increased perioperative morbidity. Furthermore, after PC, 11% of patients underwent common bile duct stone elimination through the route created by cholecystostomy, thereby avoiding endoscopic retrograde cholangiopancreatography and surgical exploration of the common bile duct. The success rate in this subgroup was 100%, with no morbidity and zero fatalities. In the patients with acalculous cholecystitis (12% of patients), surgery was avoided altogether and the drain was removed when the infection subsided. In the present study of a critically ill, high-risk population, PC proved to be a safe option, with a technical success rate of 100%. The 18% in-hospital 30-day mortality rate was attributable mainly to the poor medical condition of the patients. Similar to the study of Melloul et al.,24 additional common bile duct stones were effectively eliminated through the cholecystostomy access. All patients with calculous cholecystitis who survived PC underwent cholecystectomy, with a generally satisfactory outcome. The post-surgery morbidity rate was 5.6% compared to 2.8e15% in the medical literature, and the mortality rate was 2.8% compared to 5.6e18% in the literature.7 These findings suggest that scheduled cholecystectomy after PC may prevent biliary complications over the long term. Currently, there are no clear guidelines for selecting patients who may benefit from PC over urgent cholecystectomy, and the decision relies mainly on clinical judgment. The ongoing retrospective, controlled Chocolate study is assessing which treatment modality is best suited for critically ill patients, but it does not include critically ill patients with acalculous cholecystitis. The main strength of the present study is the large sample size. To the authors’ knowledge, this is the largest such series to date published in the English language medical literature. The main limitations of the study are its retrospective design and its restriction of the study population to a single medical centre. Moreover, there was no control group, and patients were not blinded to their treatment. Further studies are needed to corroborate and expand the present findings. Nevertheless, given the high technical success rates and good outcomes of the procedures, early percutaneous gallbladder drainage has a place in the early management of acute cholecystitis in critically ill patients.
References 1. Hirota M, Takada T, Kawarada Y, et al. Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg 2007;14:78e82.
2. Laurila J, Syrjala H, Laurila PA, et al. Acute acalculous cholecystitis in critically ill patients. Acta Anaesthesiol Scand 2004;48:986e91. 3. Steiner CA, Bass EB, Talamini MA, et al. Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland. N Engl J Med 1994;330:403e8. 4. Wiseman JT, Sharuk MN, Singla A, et al. Surgical management of acute cholecystitis at a tertiary care center in the modern era. Arch Surg 2010;145:439e44. 5. Kum CK, Eypasch E, Lefering R, et al. Laparoscopic cholecystectomy for acute cholecystitis: is it really safe? World J Surg 1996;20:43e8. 6. Kiviluoto T, Siren J, Luukkonen P, et al. Randomized trial of laparoscopic vs open cholecystectomy for acute and gangrenous cholecystitis. Lancet 1998;351:321e5. 7. Radder RW. Ultrasonically guided percutaneous catheter drainage for gallbladder empyema. Diagn Imaging 1980;49:330e3. 8. Winbladh A, Gullstrand P, Svanvik J, et al. Systematic review of cholecystostomy as a treatment option in acute cholecystitis. HPB (Oxford) 2009;11:183e93. 9. Elyaderani M, Gabriele OF. Percutaneous cholecystostomy and cholangiography in patients with obstructive jaundice. Radiology 1979;130:601e2. 10. Koebrugge B, van Leuken M, Ernst MF, et al. Percutaneous cholecystostomy in critically ill patients with a cholecystitis: a safe option. Dig Surg 2010;27:417e21. 11. Atar E, Neiman C, Ram E, et al. Percutaneous transpapillary elimination of common bile duct stones utilizing existent gallbladder drain for access. Isr Med Assoc J 2012;14:1e4. 12. Lever A, Mackenzie I. Sepsis: definition, epidemiology, and diagnosis. Br Med J 2007;335:879e83. 13. Edlund G, Ljugdahl M. Acute cholecystitis in the elderly. Am J Surg 1990;159:414e6. 14. Margiotta SJ, Willis IH, Wallack MD. Cholecystectomy in the elderly. Am Surg 1988;54:34e9. 15. Lujan JA, Parilla P, Robles R, et al. Laparoscopic cholecystectomy vs open cholecystectomy in the treatment of acute cholecystitis: a prospective study. Arch Surg 1998;133:173e5. 16. Patel M, Miedema BW, James MA, et al. Percutaneous cholecystostomy is an effective treatment for high-risk patients with acute cholecystitis. Am Surg 2000;66:33e7. 17. Eldar S, Sabo E, Nash E, et al. Laparoscopic cholecystectomy for the various types of gallbladder inflammation: a prospective trial. Surg Laparosc Endosc 1998;8:200e7. 18. Berber E, Engle KL, String A, et al. Selective use of tube cholecystostomy with interval laparoscopic cholecystectomy in acute cholecystitis. Arch Surg 2000;135:341e6. 19. Schwesinger WH, Sirinek KR, Strodel WE. Laparoscopic cholecystectomy for biliary tract emergencies: state of the art. World J Surg 1999;33:334e42. 20. Ginat D, Saad WE. Cholecystostomy and transcholecystic biliary access. Tech Vasc Interv Radiol 2008;11:2e13. 21. Griniatsos J, Petrou A, Pappas P, et al. Percutaneous cholecystostomy without interval cholecystectomy as definitive treatment of acute cholecystitis in elderly and critically ill patients. South Med J 2008;101:586e90. 22. Ha JP, Tsui KK, Tang CN, et al. Cholecystectomy or not after percutaneous cholecystostomy for acute calculous cholecystitis in high-risk patients. Hepatogastroenterol 2008;55:1497e502. 23. Morse BC, Smith JB, Lawdahl RB, et al. Management of acute cholecystitis in critically ill patients: contemporary role for cholecystostomy and subsequent cholecystectomy. Am Surg 2010;76:708e12. 24. Melloul E, Denys A, Demartines N, et al. Percutaneous drainage versus emergency cholecystectomy for the treatment of acute cholecystitis in critically ill patients: does it matter? World J Surg 2011;35:826e33. 25. Holzheimer RG, Mannick JA, editors. Surgical treatment: evidence-based and problem-oriented. Munich: Zuckschwerdt; 2001. 26. Joseph T, Unver K, Hwang GL, et al. Percutaneous cholecystostomy for acute cholecystitis: ten-year experience. J Vasc Interv Radiol 2012;23:83e8.