well i strongly agree with you about the weakness of TK 13 on stratifing comorbidities therefore in current practice i routinely use PC on patients with either grade 2 AC bearing severe comorbidities and failing to responf to medical treatment after three days of high dose broad spectrum antibiotics

the following question, in my opinion, should be how to manage elderly or severely hill patients after the acute phase resolved and the dreinage remains in site

i'm curently studing the recurrence rate among patients treated by PC alone

any experience on the issue?

In our practice we perform laparoscopic cholecystectomy in all patients that present with an acute cholecystitis (AC) of early onset unless they have severe comorbidities that do not allow for a surgical operation. Even septic patients in the ICU due to AC may be considered as candidates for an open cholecystectomy if in a multidisciplinary meeting it is decided that the cholecystectomy will greatly improve their status. That being said I believe that the adherence in TG13 is not absolute.

Patients that undergo a medical treatment will be considered for a percutaneous cholecystostomy (PC) after 48h of failure to clinically improve under broad spectrum antibiotics. In our experience PC is an effective treatment for these patients.

The major issue as Dr Polistina pointed out is how long to keep the drain in place in these fragile patients. We tend to clamp the drain and discharge the patient with the drain clamped. It will be removed in the outpatient department one month after the discharge. 

Then again there are those patients that will have recurrent episodes of AC or even Common Bile Duct (CBD) stone migration after the drain is removed. They are offered medical treatment and ERCP in the case of CBD stones. However their status combined with a severely retracted and post - inflammatory gallbladder makes a PC (as well as laparoscopic cholecystectomy)

Thank you guys for your comments.

AC is generally managed via cholecystectomy in Germany with PC being rarely performed. I can recall just two cases of PC. In both cases, PC was used as a bridge to surgery and cholecystectomy was performed within a few days.  I therefore lack the expertise to discuss this issue from a clinical perspective.

However, i feel very uncomfortable about PC for many reasons.

First, the number of publications on PC prior to the Tokyo guidelines is negligible in comparison to the number of papers after the publication of the Tokyo guidelines. This to my understanding is a direct influence of the treatment algorithm for grade 2 and 3 AC.  A vast portion of these patients are probably candidates for primary cholecystectomy. I therefore agree with Dimitrios that the decision to perform PC should be individualized irrespective oft he TK13 guidelines. 

Second, the current evidence on the benefit of PC is extremely weak. Most data is from retrospective series with limited case numbers and probably strict patient selection. Besides, many authors tend to publish only works with positive results so that it is difficult to say whether or not such results could be projected on a general population. This is also true with regard to the differences in institutional standards (e.g. 72h at Francesco´s institute and 48 h at Dimitrios´).  

Larger series (Anderson JE, Inui T, Talamini MA, Chang DC: Cholecystostomy offers no survival benefit in patients with acute acalculous cholecystitis and severe sepsis and shock. The Journal of surgical research 2014, 190(2):517-521.) and systematic reviews ( Gurusamy KS, Rossi M, Davidson BR: Percutaneous cholecystostomy for high-risk surgical patients with acute calculous cholecystitis. The Cochrane database of systematic reviews 2013, 8:CD007088) or (Winbladh A, Gullstrand P, Svanvik J, Sandstrom P: Systematic review of cholecystostomy as a treatment option in acute cholecystitis. HPB : the official journal of the International Hepato Pancreato Biliary Association 2009, 11(3):183-193.) have not been able to prove the benefit of PC in the management of critically ill patients with AC.

Third, to my understanding the focus of inflammation in AC is the gallbladder wall. The gallbladder content might by involved in just a few cases (20%) with empyematous cholecystitis. While gallbladder drainage seems reasonable in cases with empyematous cholecystitis, the remaining cases should be managed via removal of the inflamed gallbladder.  Since it is not possible to select the 20% of cases with empyema, surgery in my opinion should be grossly indicated.

Fourth, current evidence shows that delaying surgery might be associated with increased morbidity (due to dissection difficulties) and mortality (following sepsis / complications). These could be arguements to perform surgery as soon as possible.

Fifth, what happens with the patient after tube removal? Francesco would hopefully be able to provide us with some data in the future.

In my department, AC is surgically managed during the index admission. Cholecystectomy is scheduled depending on the clinical presentation, i.e. emergency cholecystectomy (next procedure), urgent cholecystectomy (as soon as possible) and early cholecystectomy (within 72h).  We use clinical and patient - dependent factors in the clinical decision – making. This could be objectified in a newly published scoring system (Ambe PC, Papadakis M, Zirngibl H: A proposal for a preoperative clinical scoring system for acute cholecystitis. J Surg Res 2015)

Despite its common nature, the management of AC is still a topic of discussion. More research is needed to improve patientcare. I am thankful for such discussions.

Francesco, you may find this paper interesting:

Mizrahi I, Mazeh H, Yuval JB, Almogy G, Bala M, Simanovski N, Ata NA, Kuchuk E, Rachmuth J, Nissan A et al: Perioperative outcomes of delayed laparoscopic cholecystectomy for acute calculous cholecystitis with and without percutaneous cholecystostomy. Surgery 2015, 158(3):728-735.

INTRODUCTION: The role of percutaneous cholecystostomy (PC) in the management of patients with acute calculous cholecystitis (ACC) remains controversial. The aim of this study is to report operative outcomes in a large cohort of patients undergoing PC before their delayed laparoscopic cholecystectomy (DLC). METHODS: All patients who underwent DLC because of ACC between 2003 and 2012 were included. Outcomes of patients with and without previous PC were compared. RESULTS: Of 639 patients who underwent DLC because of ACC at our institution during a 10-year time interval beginning 2003, 163 (25.5%) patients had PC before their DLC. Patients who underwent PC were older (64 +/- 1 years vs 48 +/- 0.8 years, P < .001) and had more comorbid conditions (P < .001). Accumulated duration of stay was longer in the PC group (16.2 +/- 0.4 days vs 9.7 +/- 0.1 days, P < .001). Rate of conversion to open procedure was greater in the PC group (11% vs 4%, P = .001) and operative time was longer (142 +/- 4 minutes vs 107 +/- 4 minutes, P < .001). Patients in the PC group had a greater rate of biliary-related complications (10% vs 4%, P = .003) and surgical-site infections; both superficial (5% vs 1%, P = .004) and deep (7% vs 3%, P = .04). On multivariable analysis PC was an independent risk factor for conversion to open cholecystectomy (odds ratio 2.67 95% CI 1.18-6.72) as well as to biliary-related complications (odds ratio 4.85 95% CI 1.57-14.92). CONCLUSION: DLC for ACC in patients with previous PC is associated with longer duration of stay, more readmissions, and, most importantly, greater conversion rate, biliary related complications, and surgical-site infections.

Although, I´m not familiar to the surgical conduct of percutaneous cholecystostomy (gallbladder drainage but, considering defined diagnostic criteria, of the TK 13 that enable a classification of acute cholecystitis in three severity grades. Grade I - mild  inflammation =Laparoscopic cholecystectomy l (LC); grade II - moderate gallbladder inflammation and grade III - severe gallbladder inflammation; a portion of patients with grade II should undergo LC in centers with expertise while all other patients (the rest of grade II and all grade III patients) should be managed via percutaneous cholecystostomy (PC). 

My opinion is that dysfunction is not limited only to the gallbladder but circumstance of the gastro-enterologic system that warranted, transit and sphyncteric incoordination leading to bile stones due to stasis, increased bacterial degradation and other physio-pathologic complex, which if combated systematically in many cases during acute cholecystitis symptoms could avoid or delay most surgical intervetion.

thank you very much Peter. The paper is truly relevantin my previoua answer i did not mention the true fact that in my dept also the main attitude is to perform cholecistectomy in all patients with AC regardless of the stage providing that the operative risk temains acceptable.

patients presenting with higher operative risk, mostly due to associated chronic disease not responding to antibiotics undergo PTCD.

Once again you are right when remembering me that inly 20 to 30% of patients with AC has empyematous AC but im my experince even patints without EC do dramatically improvr after PTCD. This may be due to the reduction of the pressure on the GB wall and subsequent improve in parietal blood flow.

Interesting abstract by dr. Ambe. Has it been considered that the drained gallbladders were the nasty sort - and since this was not a randomized study, the groups were not comparable and thus not an argument for or against PC?

Answering the primary question about familiarity: We have a long clinical experience with PC, but not selected according to the Tokyo classification. The primary reason for choosing DLC in our facility is the disease time - as AC approaching one week of disease time is more difficult to operate and thus have a higher risk of complications. In septic patients with AC that do not respond to conservative treatment - and with over one week of disease time - we often choose PC and we have not observed failures with this strategy. We leave the drain open for 7-10 days, to be removed in the out-patient clinic the following week, but using the drain to perform a cholangiography before the patients are dismissed. Many drains dislocate within a week, so this has become the standard as opposed to delayed cholangiography. MRCP is unnecessary in many patients with cholangiography performed. The drain is placed transhepatically, which often drains an accessory abscess in-between the liver and the gallbladder - and aimed for if detected during placement. Transhepatical is also more secure in regard of drain dislocation and leakage to the abdominal cavity.

Emphysematous cholecystitis (EC), most often seen in acalculous AC,  is a late sign fore a more agressively developing AC which should be dealt with, if possible by LC as early as possible, but also PC is a rescue procedure in selected patients. Often, the question is not whether the patient is healthy enough to withstand a LC, but rather whether the patient is too sick to not having a LC. Empyema is difficult to asses with image studies, but a drain gives the answer to that question.

In summary, drainage is not a first-line option, but can be very helpfull in prolonged disease. The recurrence rate of AC is not so high and in selected old patients, PC can provide the final treatment. Peroperative cholangiography is standard procedure in all cholecystectomies in our facility, acute as well as elective, including delayed, LC.

PC is useful in unwell or very unfit patient who cannot have surgery but i think it is only required in a very small proportion if cases and lap chole can more often than not be successful in managing acute cholecystitis. There are consequences of cholecytostomy, having a drain for weeks, bile leak, bleeding etc

Thank you for Prof. Andrey Borodach’s recent recommendation of this three years-old question on Oct. 20 2018.

I would like to share my opinions with a hope to solve the question currently we have about the laparoscopic cholecystectomy.

1. About Tokyo 13 guideline: I don’t adhere to this guideline. This is not an evidence based guideline. This is a grading of clinic signs and data without the supported evidence of intra-operative GB inflammation findings. I had been provided my opinion to Prof. Takada, the leader of this guideline, for their revised version.

1. For Grade I: there are many mild acute on chronic cholecystitis case with mild signs of inflammation; however may co-exist with severe fibrotic change. In such case, this is a difficult gall bladder (GB).

2. For Grade II: lapse time is not always proportioned to the severity of GB inflammation. Clinical symptom > 72 hours or > I week should not be a definite criterion as severe inflammation.

3. For Grade III: I don’t oppose the application of percutaneous trans-hepatic/peritoneal GB drainage (PTGBD) to relief the septic situation. Sometimes, it may be a definite treatment for the patients who are acalculous or not suitable candidate for operation; however it is not a panacea. I had experienced a mortality case with severe valvular heart disease and diabetes mellitus, PTGBD was applied instead of immediate LC. His GB was found in a necrolytic condition when open cholecystectomy was eventually necessary in a bile peritonitis situation. There is no absolute promise that GB inflammation will subside after PTGBD. In my study, the predictive result of inflammation of the difficult GB group is fibrosis if delayed interval LC policy is implemented, which will make the subsequent LC much more difficult (https://www.researchgate.net/publication/303968598_A_Predictive_Outcome_Analysis_of_Interval_Cholecystectomy_Based_on_Gall_Bladder_Inflammation_Status_during_Immediate_Laparoscopic_Cholecystectomy).

Therefore I suggest PTGBD in septic state as a bridge to the index or immediate LC instead of open cholecystectomy or delayed interval cholecystectomy. If current cholecystectomy policy is correct for the inflammation of GB stone disease, then index or immediate LC before the severe fibrosis formed should be performed by the experienced LC surgeon on those difficult GB cases. Iatrogenic fibrosis situation of the GB and vicinity structures should be avoided, especially those created by the delayed interval (6 weeks) LC strategy. The fibrosis may begin to appear in the severe inflammation case after 8th day of symptom in my series.

Thank you for sharing your opinions Dr Chang

but from my point of view, some of them are questionable

1) TK 13 guidelines have been overwhelmed by the 2018 edition that finally put in place (or definetely tried to) the role of PTCD. I may agree with your statement that they're not evidence based baut i'd a simple question for you: whic guideline on the issue may be seriously defined as "evidence based"? you certainly know thw attempt from Varadachary and colleagues to perform a meta-analysis on the AC issue. Well they concluded that for that scope we should program a prospective randomized study enrolling not least than 50.000 patient per study arm

2) One may even find a patient tyhat had never experienced AC to have a "difficult gallbladder". This is why Lap Chole is not an easy procedure

3)Absolutely i agree with you

4)The main issue on grade III AC is, in my opinion, the SIRS presence. Since patients experience a systemic damage it makes a little sense to perform any operation. PD has the advantage of removing the causes with a little systemic impact and this may happen through at least two different routes: a) removes the pus from the empyema; b) improves the parietal pefusion by resolving idrostatic tension and increases the efficacy of antibiotics. In my personal experience, PCD arries a mortality rate as high as the natural hystory of the disease. Either lap or open chole are certainly options for patient with a good performance status and/or no need for ICU and, once again i agree should be performed only by trained and experienced dedicated surgeons.

I totally disagree on the use of the operative cholecystolilhotomy, it carries the systemic damage of an abdominal operation, the risks of a suture on an inflamed tissue and do not resolve the stone issue. In my opinion this knd of procedure should be banded from the surgeon's skills

Dear Dr. Polistina

Thank you for your comments.

1. I am not asking a randomized study to support TK guideline. If surgeons can record and photo the macroscopic inflammation status during each LC of the Grade I & II of TK 13, then we can retrospectively verify the justification of TK 13 guideline easily. Also the questionable suggestion of biliary drainage for Grade II case (s/s > 72 hours, WBC > 18,000, positive Murphy’s sign, RUQ palpable mass) can be checked as well.

2. In Tokyo guideline 2018, they have modified the criteria of biliary drainage + delayed LC. Some cases are allowed to perform early LC without drainage. Yet, the timing of delayed LC is not indicated and fibrosis consequence may not be averted.

About the cholecystolithotomy issue, there is a trend by the endoscopist performing TED (transluminal endoscopic drainage) with lumen-apposing metal stent (LAMS), after their success in treating acute necrotizing pancreatitis, to replace PTGBD with promising results. I am expecting this trend to solve the problem of drainage and cholecystolithotomy (spontaneous dislodge or endoscopic removal of the stones from LAMS) and to avert the risk of challenging a difficult GB.

(Feasibility and safety of endoscopic ultrasound-guided gallbladder drainage using a newly designed lumen-apposing metal stent - Surg Endosc 2018 Oct 17. doi:10.1007/s00464-018-6485-5)

Once again i thank you for sharing

TED is somewhat an unexplored field

In my opinion it may be comparedo to PTCD with a very few advantages if one.

First of all, i suppose that anyone will agree if i say that it may treat severe AC in patients unfit for surgery, therefore the only meaningfull comparison should be done with PCD, agree?

well let's try ro make a comparison between the procedures

1) PCD local anesthesia, TED at least deep patient sedation

2) PCD takes about 10 minutes, TED i guess much more

3) PCD may be safely performed almost ever, TED has some contraindications (previous surgery, Portal hypertension, ascites)

4) Success rate seems to be higher in PCD

5) complications related to PCD are rare and usually not life threatening, complciations from TED seem to be somewhat more difficult to deal with

6) After PCD one can still perform a lap chole to finally treat the disease, TED will never allow you to perform a routine cholecystectomy with a reasonable operative risk

which procedure should you choose?

Dear Dr. Polistina :

Thank you for your response.

As I had mentioned earlier, I do not oppose PTGBD. But, I think that TEGBD has a potential to become a new trend. I am expecting more reports of cholecystolithotomy by the TEGBD to know if the subsequent difficult cholecystectomy as well as IBD injury, can be omitted. If bile stasis can be solved eventually by this fistula, then stone formation may not recur in the GB or may spontaneous dislodge from the fistula; therefore there is no need for a cholecystectomy.