0. To operate or not to operate
To operate or not to operate? On acute cholecystitis in elderly and critically ill patients
Dr. Prashanth Sreeramoju
Assistant Professor of Surgery
Montefiore-Einstein Medical Center

1. Goal :
To provide evidence supporting the non-operative management of acute cholecystitis(AC) in elderly and critically ill patients as a safe and effective bridge treatment strategy
My goal for today is to convince the audience and

2. Introduction Definitions of terms Elderly > 65 years
Severe acute cholecystitis - based on Tokyo Guidelines (TG07) – acute cholecystitis with systemic or organ dysfunction/s
Critically ill pts
ASA class IV or above
APACHE II score > 12; SAPS >15 (Simplified Acute Physiology Score); SOFA (Sequential Organ Failure Assessment)
Definition of terms – Literature considers anyone aged above 65 years as elderly
Definition of severe acute cholecystitis is based on TG07 which is acute cholecystitis with an organ dysfunction or multiple
Most of the studies in the literature considered a pt as critically ill, if they belong to ASA class IV or above or if they have APACHE two score of more than 12 or SAPS of more than 15
All those measurements consider acute physiological changes and chronic comorbidities.

3. Tokyo Guidelines for acute cholecystitis (TG 07)
Mild - RUQ pain w/murphy’s signs and USG findings (40-70%)
Moderate - acute cholecystitis w/ WBC >18K; >72hrs of symptoms; palpable tender mass (25%-60%)
Severe - acute cholecystitis with organ dysfunction/s
Tokyo Guidelines for acute cholecystitis were published in 2007 to provide diagnostic criteria and severity assessment criteria for acute cholecystitis. They have proposed these guidelines for appropriate treatment strategies and better outcomes.

4. Severe acute cholecystitis
Incidence % are severe acute cholecystitis
Severe acute cholecystitis – acute cholecystitis along with one of the below:
Cardiac dysfunction (pressor requirement)
Neurologic dysfunction (altered mental status)
Hepatic dysfunction (INR >1.5)
Renal dysfunction (Cr > 2.0mg/dl)
Respiratory dysfunction (PaO2/FiO2 ratio <300)
Hematologic dysfunction (Plt count <100K)
For the purpose of today’s talk we will concentrate on severe acute cholecystitis. It’s incidence is about 1-6% among the pts present with acute cholecystitis.
Severe cholecystitis is associated with an organ or multiple organ dysfunction as listed below.

5. Cholecystitis in critically ill pts
Calculus cholecystitis (ACC) vs Acalculus cholcystitis(AAC)
AAC seen in 10-20%
High mortality rates of up to 50%
Gallstones is still a common cause of cholecystitis in critically ill patients. However, Acalculous cholecystitis is seen in about 10-20% of criitically pts.
Cholecystitis in critically ill patients is associated with high mortality rates of up to 50% compared to mere 1% in non-critically ill patients.
Surgical management in these patients carry mortality rate of 4-6%

6. Non-operative management of cholecystitis
Antibiotics covering gram – bacilli and anaerobic organisms
Gall bladder drainage procedures
Percutaneous vs Endoscopic transpapillary approach
Non operative management for cholecystitis involves broad spectrum antibiotics covering gram – bacilli and anaerobic organisms and gall bladder drainage procedures It can be done either percutaneously or endoscopically under monitored anesthesia care. Of course better pain control; a happy patient, a happy doctor!!

7. Studies comparing percutaneous cholecystostomy(PC) vs cholecystectomy(CCY)
A nationwide examination of outcomes of percutaneous cholecystostomy compared with cholecystectomy for acute cholecystitis (Surg Endosc (2013) 27:3406–3411)
Study group
Time frame
Type of study
Morbidity
PC CCY
Mortality
PC CCY
Length of stay
Conver-sion rate
Talamini
et al, 2013
Retrospective
4.1%
8.5%
p<0.05%
11%
1.1%
PC>CCY
Oleynikov D. et al,2013 5% 8%
2.6%
2.1% NS
PC<CCY
26.5%
McGillcudd-y et al, 2012 4%
9.2%
N/A
20.3%
Melloul
et al, 2011
8.7%
47%
13%
16%
Abi-Haidar et al, 2012
2.9%
1.9%
15.4%
4.5%
24%
Emergent cholecystostomy is superior to open cholecystectomy in extremely ill patients with acalculous cholecystitis: a large multicenter outcome study (Am J Surg (6), )
I did extensive literature search to find best evidence for non-operative management of cholecystitis in critically ill patients and to prove my talk for today. Unfortunately, I found mostly retrospective studies and only few of them made head to head comparison between nonoperative and surgical management. Surgical management involves laparoscopic cholecystectomy or open. I have selected five of those studies and assimilated in to this table highlighting their key findings. Rather findings which we are interested in !!
Frist study is a “nationwide examination…..” recently published in Surgical Endoscopy journal. A retrospective study involving patients in the time frame There is a homogenous distribution of Patients characteristics in each group. It showed that group managed non-operatively has significantly lower morbidity rate compared to surgical group. Their high mortality rate in conservative mgmt groups is explained due to their critically ill condition not due to cholecystitis or procedure.
Second study- is another recently published paper in the Am J of surgery titled – “ Emergent cholecyst…..” another retrospective study showing significantly low morbidty rate in nonopeartive mgmt compared to CCY group.
Third study - retrospectively evalauted non-op mgmt of acute cholecystis in elderly. Published in British J of surgery in demonstrated low complication rate in non-op mgmt
Fourth study – published in World J of surgery, year 2011 comparing percutaneous drainage vs. emergency cholecystectomy for the treatment of acute cholecystitis in critically ill pts. It showed similar results of significantly low morbidity rate in percutaneous group
Last study I would like to discuss showed contradictory results compared to previously described studies. It is paper from Archives of surgery published in 2012 ,assessing the data from VA hospital in Boston.. Reviewing a decade experience of percutaneous cholecystomy for acute cholecystitis. It was a poorly analyzed study. Comparing apples with oranges.. Pts in the PC are significantly sicker pts with ASA class IV compared to pts in surgery group who belong to ASA class I or II.
Non-operative management of acute cholecystitis in the elderly (Br J Surg 2012; 99: 1254–1261)
Percutaneous Drainage versus Emergency Cholecystectomy for the Treatment of Acute Cholecystitis in Critically Ill Patients: Does it Matter? (World J Surg (2011) 35:826–833 )
Revisiting Percutaneous Cholecystostmy for Acute Cholecystitis Based on a 10-Year Experience (Arch Surg. 2012;147(5): )

8. Limitations in the literature
Recommendation grading (Guyatt and colleagues) -2C
No randomized/prospective trials
Limitations in the literature, as per Recommendation grading system, current literature provides a weak evidence for non-operative management. There are no randomized or prospective trials so far..

9. Cholecystitis in cirrhosis and pregnancy
AC in Cirrhosis
Morbidity rates child A 18%; Child’s B 37% ; Child C 75%
MELD score >13 - complication rates
AC in pregnancy
Conservative management in 1st and 3rd trimester
Surgical intervention for Cholecystitis in Child’s C cirrhosis patients carry significantly higher morbidity rates compared to Child A and Child B cirrhosis.
Pts with high MELD score more than 13 are prone for increased complications
Management of cholecystitis in pregnancy has been always a challenge, as we need to worry about two life's. Old data suggests non-operative management in the 1st and 3rd trimester with Safe window of opportunity for surgical intervention in the second trimester.
However, new literature shows a cholecystectomy can be safely performed in any trimester. It might be due to advancements of surgical technology and surgeons becoming more skillful laparoscopically.
Pregnant pts who are conservatively managed before have 40-50% recurrence of symptoms.

10. Gall bladder mass – indications for non-surgical management
Unresectable tumors Stage III/IV
5-year survival rate 5% and 1 % respectively
Median OS – 5.8months
Management
Biliary drainage procedures - ERCP/PTC
Clinical Trials
Gemcitabine or 5-FU based CTx
Best supportive care
Unresectable gall bladder tumors is an another indication for conservative management. Most of these pts belong to stage III and IV as per TNM staging system. They have poor 5- year survival rate in the range of 1-5% with median overall survival of 6months.
Their management involves best supportive care and biliary drainage procedures. Some are enrolled in clinical trials or Gemcitabine or 5-FU based Ctx

11. Objectives of non-operative management
Avoids general anesthesia risk
Optimizes pt for definitive treatment
Avoids Higher risk of conversion
Decreases morbidity rate
Objectives we achieve with nonoperative management are : First – To avoid risk associated with general anesthesia in critically ill patients.
Second – to optimize those patients for a definitive treatment later
Third –retains the advantages of laparoscopic procedure at a later stage
Fourth – Non operative mgmt has low morbidity rate

12. Conclusion To operate? or Not to operate !
In conclusion I would think non-operative management of acute cholecystitis in elderly and critically ill patients is definitively a safer option with less complications. To keep it simple, it is like managing an abscess by draining it.
However, because of the limitations in current literature, in future there is a need for better prospective studies to assess the true efficacy of non-operative management.

13. References:-
A nationwide examination of outcomes of percutaneous cholecystostomy compared with cholecystectomy for acute cholecystitis, Surg Endosc (2013) 27:3406–3411
Emergent cholecystostomy is superior to open cholecystectomy in extremely ill patients with acalculous cholecystitis: a large multicenter outcome study. Am J Surg (6),
2013 WSES guidelines for management of intra-abdominal infections. World J Emerg Surg. 2013; 8: 3.
TG13 surgical management of acute cholecyst. J Hepatobiliary Pancreat Sci Jan;20(1):89-96
Non-operative management of acute cholecystitis in the elderly. British J Surg 2012; 99: 1254–1261

14. Revisiting Percutaneous Cholecystostomy for Acute Cholecystitis Based on a 10-Year Experience. Arch Surg. 2012;147(5):
Percutaneous Drainage versus Emergency Cholecystectomy for the Treatment of Acute Cholecystitis in Critically Ill Patients: Does it Matter? World J Surg (2011) 35:826–833
NCCN guidelines consortium
Laparoscopic management of appendicitis and symptomatic cholelithiasis during pregnancy. Langenbecks Arch Surg Sep;391(5):467-71
Cirrhosis is not a contraindication to laparoscopic cholecystectomy: results and practical recommendations. HPB (Oxford) Mar;13(3):192-7.

15. Questions ?