Professional Documents
Culture Documents
Kjg063 01 06
Kjg063 01 06
1, 32-38
http://dx.doi.org/10.4166/kjg.2014.63.1.32
pISSN 1598-9992 eISSN 2233-6869
ORIGINAL ARTICLE
Background/Aims: Percutaneous cholecystostomy (PC) is an effective treatment for cholecystitis in high-risk surgical patients.
However, there is no definitive agreement on the need for additional cholecystectomy in these patients.
Methods: All patients who were admitted to Cheju Halla General Hospital (Jeju, Korea) for acute cholecystitis and who underwent
ultrasonography-guided PC between 2007 and 2012 were consecutively enrolled in this study. Among 82 total patients enrolled,
35 underwent laparoscopic cholecystectomy after recovery and 47 received the best supportive care (BSC) without additional
surgery.
Results: The technical and clinical success rates for PC were 100% and 97.5%, respectively. The overall mean survival was
12.8 months. In the BSC group, mean survival was 5.4 months, and in the cholecystectomy group, mean survival was 22.4
months (p<0.01). However, there was no significant difference between these groups in multivariate analysis (relative risk
[RR]=1.92; 95% CI, 0.77-4.77; p=0.16). However, advanced age (RR=1.05; 95% CI, 1.02-1.08; p=0.001) and higher class
in the American Society of Anesthesiologists’ physical status (RR=3.06; 95% CI, 1.37-6.83, p=0.006) were significantly associated
with survival in the multivariate analysis. Among the 47 patients in the BSC group, the cholecystostomy tube was removed
in 31 patients per protocol. Recurrent cholecystitis was not observed in either group of patients during the follow-up period.
Conclusions: In high-risk surgical patients, PC without additional cholecystectomy might be the best definitive management.
Furthermore, the cholecystostomy drainage catheter can be safely removed in certain patients. (Korean J Gastroenterol
2014;63:32-38)
Received November 8, 2013. Revised December 10, 2013. Accepted December 10, 2013.
CC This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/
by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
*Byung Hyo Cha and Sang Hyub Lee equally contributed as co-first authors.
교신저자: 차병효, 690-766, 제주시 도령로 65, 제주한라병원 내과 소화기병센터
Correspondence to: Byung Hyo Cha, Digestive Disease Center, Department of Internal Medicine, Cheju Halla General Hospital, Doreongno 65, Jeju 690-766, Korea.
Tel: +82-64-740-8050, Fax: +82-64-743-3110, E-mail: drhyo@hotmail.com
Financial support: None. Conflict of interest: None.
3-6
and safe treatment modality. at admission based on clinical findings, laboratory data, and
However, patients with poor physical status often cannot radiologic tests, including abdominal ultrasonography (US)
undergo surgery on admission because of problems such as and/or CT. Positive clinical findings were defined as right up-
severe sepsis, extreme old age, and comorbidities. Although per quadrant or epigastric pain, tenderness, and fever.
cholecystectomy is generally safe, the mortality rate of chol- Positive laboratory findings were defined as leukocytosis or
ecystectomy in patients with high surgical risk, especially the positive C-reactive protein. Positive diagnostic through US or
elderly or critically ill, has been reported between 14% and CT findings included gallbladder wall thickening, gallbladder
7-9 14
30%. distension, and presence of inflammatory material.
Ultrasonography-guided transhepatic percutaneous chol- This study protocol was approved by the Institutional
ecystostomy (PC) is a minimally invasive, image-guided inter- Review Board of Cheju Halla General Hospital. And this study
vention performed under local anesthesia. Therefore, it has protocol also was registered to www.clinicaltrials.gov. and
become a useful therapeutic intervention in elderly or crit- was approved (No. NCT01894321).
10,11
ically ill patients. However, it has been considered as a
bridging modality for high-risk surgical patients until surgical 2. Procedure techniques
12,13
treatment, cholecystectomy. It remains controversial Percutaneous transhepatic cholecystostomy was per-
whether this procedure should only be used as a temporary formed by an expert interventional radiologist with US and
measure to delay definitive cholecystectomy or if this proce- fluoroscopic guidance in the interventional unit. After local
dure can be a definitive treatment. anesthesia was injected, an 18-gauge needle was inserted
The aim of this study was to determine if PC is appropriate at the sterile puncture site, and a 7F to 10F locking pigtail
as definitive treatment for acute cholecystitis in patients with cholecystostomy catheter was placed into the gallbladder
high surgical risks, using a well-designed management fundus through the guidance of wire. Bile samples were ob-
protocol. tained for culture, and the catheter was kept in place for gall-
bladder drainage. The catheter lumen was then flushed ev-
SUBJECTS AND METHODS ery 8 to 12 hours to prevent obstruction.
Technical success was defined as the proper positioning
1. Study population of the cholecystostomy tube into the gallbladder lumen and
All patients who were admitted to Cheju Halla General proper bile juice drainage without any complications. Clinical
Hospital (Jeju, Korea) via the emergency center or outpatient success was defined as the resolution of clinical symptoms
clinic with acute cholecystitis and who underwent ultra- and abnormal laboratory results after successful technical
sonography-guided PC between November 2007 and drainage. All patients recovering from acute treatment were
November 2012 were consecutively enrolled in this study re-assessed for elective cholecystectomy after successful
(Fig. 1). The diagnosis of acute cholecystitis was established cholecystostomy.
3. Post-cholecystostomy management
The physician, surgeon, anesthesiologist, and interven-
tional radiologist discussed each case to determine further
strategies, including elective cholecystectomy. The American
Society of Anesthesiologists’ (ASA) physical status classi-
15
fication, Eastern Cooperative Oncology Group (ECOG) per-
16
formance scores, clinical condition, and comorbidities that
might affect surgical outcomes were considered for each
groups were compared with the use of the log rank test. The proved with medical treatment alone.
hazard ratio was estimated using a stratified Cox propor- Among the 82 PC patients, 35 patients underwent laparo-
tional hazard model. All the statistical analyses were carried scopic cholecystectomy and 47 were managed by BSC. In the
out using SPSS software version 15.0 (SPSS Inc., Chicago, IL, cholecystectomy group, the mean bridging period (defined as
USA). the time between cholecystostomy and elective cholecystec-
tomy) was 7.43±4.99 days. Operation related mortality oc-
RESULTS curred in 2 cases (5.71%), 1 with bile peritonitis and 1 with
wound infection. In the BSC group, 16 patients treated with
A total 82 subjects that underwent ultrasound-guided PC cholecystostomy had their tube left in place, while 31 pa-
were enrolled in this study. Listed comorbidities are shown in tients were extubated following cholecystostomy manage-
Table 1. Baseline characteristics of the enrolled patients and ment protocols.
the two groups are described in Table 2.
The technical success rate for PC was 100%, and the clin- 1. Baseline characteristics and clinical outcomes be-
ical success rate was 97.5% (80 of 82 patients). A 76-year-old tween cholecystectomy and BSC groups
male patient underwent emergent cholecystectomy be- Baseline characteristics of the 2 treatment groups are
cause of ongoing severe pain with fever and insufficient
drainage despite appropriate medical treatment with anti-
a
Table 2. Baseline Characteristics of the Subjects
biotics and analgesics. A 71-year-old male patient, who was
admitted with multiple organ failure (septic shock, renal fail- Best
Cholecystec-
supportive Total
ure, respiratory distress syndrome, and loss of conscious- tomy group p-value
care group (n=82)
(n=35)
ness), died of organ failure in the intensive care unit (ICU), de- (n=47)
spite successful drainage and aggressive medical therapy, Age (yr) 71.0±12.2 73.0±14.7 72.1±13.7 0.519
Sex 0.460
including infusion of inotropic agents, mechanical ven-
Male 20 (57.1) 23 (48.9) 43 (52.4)
tilation, and administration of antibiotics. Caregivers of the Female 15 (42.9) 24 (51.1) 39 (47.6)
patient refused urgent operative management. Procedure- ASA class <0.001
≤3 31 (88.6) 18 (38.3) 49 (59.8)
related complications occurred in 2 cases (2.4%) with bile ≥4 4 (11.4) 29 (61.7) 33 (40.2)
leakage peritonitis, and the condition of these patients im- ECOG class <0.001
≤2 26 (74.3) 6 (12.8) 32 (39.0)
≥3 9 (25.7) 41 (87.2) 50 (61.0)
Gallstone 0.130
a
Table 1. Comorbidities of the Subjects Acalculous 12 (34.3) 24 (51.1) 36 (44.0)
Disease category Value Calculous 23 (65.7) 23 (48.9) 46 (56.0)
Hypotension 0.210
Advanced malignant disease 23 (16.5) Yes 5 (14.3) 12 (25.5) 17 (20.7)
Renal failure 20 (14.4) No 30 (85.7) 35 (74.5) 65 (79.3)
Severe cardiovascular disease 19 (13.7) Renal failure 0.340
Septic shock 18 (12.9) Yes 6 (17.1) 12 (26.1) 18 (22.2)
Severe cerebrovascular disease 15 (10.8) No 29 (82.9) 34 (73.9) 63 (77.8)
Severe neuropsychiatric disease 13 (9.4) ICU admission <0.01
Severe bone and spinal disease 9 (6.5) Yes 1 (2.9) 20 (43.5) 21 (25.9)
COPD 7 (5.0) No 34 (97.1) 26 (56.5) 60 (74.1)
Miscellaneous 6 (4.3) Follow-up 9.5 4.0 5.2 0.623
Heart failure 4 (2.9) duration (mo) (0.8-87.7) (4.0-51.5) (5.4-87.7)
Chronic repiratory disease 3 (2.2) Survival time 15.3 2.4 4.4 0.001
Decompesated liver cirrhosis 2 (1.4) (mo) (0.8-92.0) (0.1-24.8) (0.1-92.0)
Total response 139 (100.0)
Values are presented as mean±SD, n (%), or median (range).
a
Values are presented as n (%). Eighty-two enrolled acute cholecystitis patients who underwent
a
Eighty-seven patients who underwent percutaneous cholecystos- ultrasound-guided percutaneous cholecystostomy.
tomy in Cheju Halla General Hospital, Jeju, Korea, between 2007 ASA class, American Society of Anesthesiologists’ physical status
and 2012. classification; ECOG, Eastern Cooperative Oncology Group; ICU,
COPD, chronic obstructive pulmonary disease. intensive care unit.
spective study is warranted. 14. Hirota M, Takada T, Kawarada Y, et al. Diagnostic criteria and se-
In summary, we concluded that BSC with PC rather than verity assessment of acute cholecystitis: Tokyo Guidelines. J
Hepatobiliary Pancreat Surg 2007;14:78-82.
cholecystectomy may be considered in cholecystitis patients
15. Meyer S. Grading of patients for surgical procedures. Anesthe-
with extreme old age and higher morbidity (ASA ≥4). It can be siology 1941;2:281-284.
considered to recommend BSC rather than cholecystectomy. 16. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response cri-
teria of the Eastern Cooperative Oncology Group. Am J Clin Oncol
1982;5:649-655.
REFERENCES 17. Hatzidakis AA, Prassopoulos P, Petinarakis I, et al. Acute chol-
ecystitis in high-risk patients: percutaneous cholecystostomy vs
1. Everhart JE, Khare M, Hill M, Maurer KR. Prevalence and ethnic conservative treatment. Eur Radiol 2002;12:1778-1784.
differences in gallbladder disease in the United States. 18. Escarce JJ, Shea JA, Chen W, Qian Z, Schwartz JS. Outcomes of
Gastroenterology 1999;117:632-639. open cholecystectomy in the elderly: a longitudinal analysis of
2. Kalliafas S, Ziegler DW, Flancbaum L, Choban PS. Acute acalcu- 21,000 cases in the prelaparoscopic era. Surgery 1995;117:
lous cholecystitis: incidence, risk factors, diagnosis, and 156-164.
outcome. Am Surg 1998;64:471-475. 19. Morse BC, Smith JB, Lawdahl RB, Roettger RH. Management of
3. Kiviluoto T, Sirén J, Luukkonen P, Kivilaakso E. Randomised trial acute cholecystitis in critically ill patients: contemporary role for
of laparoscopic versus open cholecystectomy for acute and gan- cholecystostomy and subsequent cholecystectomy. Am Surg
grenous cholecystitis. Lancet 1998;351:321-325. 2010;76:708-712.
4. Lo CM, Liu CL, Fan ST, Lai EC, Wong J. Prospective randomized 20. McKay A, Abulfaraj M, Lipschitz J. Short- and long-term outcomes
study of early versus delayed laparoscopic cholecystectomy for following percutaneous cholecystostomy for acute cholecystitis
acute cholecystitis. Ann Surg 1998;227:461-467. in high-risk patients. Surg Endosc 2012;26:1343-1351.
5. Koo KP, Thirlby RC. Laparoscopic cholecystectomy in acute 21. Granlund A, Karlson BM, Elvin A, Rasmussen I. Ultrasound-guid-
cholecystitis. What is the optimal timing for operation? Arch Surg ed percutaneous cholecystostomy in high-risk surgical patients.
1996;131:540-544. Langenbecks Arch Surg 2001;386:212-217.
6. Lujan JA, Parrilla P, Robles R, Marin P, Torralba JA, Garcia-Ayllon 22. Ha JP, Tsui KK, Tang CN, Siu WT, Fung KH, Li MK. Cholecys-
J. Laparoscopic cholecystectomy vs open cholecystectomy in tectomy or not after percutaneous cholecystostomy for acute
the treatment of acute cholecystitis: a prospective study. Arch calculous cholecystitis in high-risk patients. Hepatogastroenter-
Surg 1998;133:173-175. ology 2008;55:1497-1502.
7. Houghton PW, Jenkinson LR, Donaldson LA. Cholecystectomy in 23. Leveau P, Andersson E, Carlgren I, Willner J, Andersson R.
the elderly: a prospective study. Br J Surg 1985;72:220-222. Percutaneous cholecystostomy: a bridge to surgery or definite
8. Frazee RC, Nagorney DM, Mucha P Jr. Acute acalculous management of acute cholecystitis in high-risk patients? Scand
cholecystitis. Mayo Clin Proc 1989;64:163-167. J Gastroenterol 2008;43:593-596.
9. Weiss CA 3rd, Lakshman TV, Schwartz RW. Current diagnosis 24. Bakkaloglu H, Yanar H, Guloglu R, et al. Ultrasound guided percu-
and treatment of cholecystitis. Curr Surg 2002;59:51-54. taneous cholecystostomy in high-risk patients for surgical
10. Vogelzang RL, Nemcek AA Jr. Percutaneous cholecystostomy: di- intervention. World J Gastroenterol 2006;12:7179-7182.
agnostic and therapeutic efficacy. Radiology 1988;168:29-34. 25. Koebrugge B, van Leuken M, Ernst MF, van Munster I, Bosscha
11. Hultman CS, Herbst CA, McCall JM, Mauro MA. The efficacy of K. Percutaneous cholecystostomy in critically ill patients with a
percutaneous cholecystostomy in critically ill patients. Am Surg cholecystitis: a safe option. Dig Surg 2010;27:417-421.
1996;62:263-269. 26. Chok KS, Chu FS, Cheung TT, et al. Results of percutaneous
12. Welschbillig-Meunier K, Pessaux P, Lebigot J, et al. Percutaneous transhepatic cholecystostomy for high surgical risk patients with
cholecystostomy for high-risk patients with acute cholecystitis. acute cholecystitis. ANZ J Surg 2010;80:280-283.
Surg Endosc 2005;19:1256-1259. 27. Griniatsos J, Petrou A, Pappas P, et al. Percutaneous chol-
13. Byrne MF, Suhocki P, Mitchell RM, et al. Percutaneous chol- ecystostomy without interval cholecystectomy as definitive
ecystostomy in patients with acute cholecystitis: experience of 45 treatment of acute cholecystitis in elderly and critically ill
patients at a US referral center. J Am Coll Surg 2003;197:206-211. patients. South Med J 2008;101:586-590.