In addition to technical deficiencies and a blowout from biliary obstruction, what are the predisposing factors, theories or experience of such a complication?
Hi Anthony, I believe metal clips are mostly part of the problem. Remember when open surgery was rule and everybody was tying knots, we were not discussing this kind of problem. At our institute, We (including residents) have not used a single metal clip for choles in the last 10 years. After more than 6.000 choles (including 1700 minis) we have not faced a single cystic stump leak. Clips are faster, but not safer when comparing with surgical knots !
Hi, Gustavo. Thanks for your sharing your experience. What do you think is the specific deficiency with metal clips (not secure enough or too crushing)? How about other types of clips? And do you "hand-tie" or use an endo-loop?
The use of metal clips are safety. The most important point is that both the laparoscopic clip applier with twenty automatically advancing clips or a single load clip applier can not present any failure such as when arms keeps away even with the device closure. Other cause is a poor dissection of Callot's triangule with excessive traction of the cystic when it is cut.
A routine test have to be made to secure that the laparoscopic applier is working and secure.
Several deficiencies can be found in metal clips: starting with failure of reusable appliers and several different kinds of clips that can fail as well (We must not forget that recent clips are much better than the ones 20 years ago).
We hand tie our knots in all choles and we prefer mostly to use minilaparoscopic approach for being much easier than with conventional 5mm forceps. A good video showing how easy is to tie a knot with the NEW mini Low-Friction equipment can be found in YOUTUBE.
http://www.youtube.com/watch?v=MMJVd7wDeGM
In short everybody knows that metal clips are not the best option for securing the cystic duct.
We must not forget that in the open surgery era not a single surgeon used to secure the cystic duct with clips.
In the MIS era cystic duct closure with clips was largely used as the standard procedure, starting in the late 1980s with the laparoscopic surgery technique. The clips, despite some inherent problems in their use, are widely accepted among laparoscopic surgeons for being more simple and faster. But for this convenience we need to pay a price, and complications never seen before, when using knots started to appear seldom.
When dealing with minilaparoscopy, replacing the clips for surgical knots significantly decreased equipment costs, for not using the expensive and fragile 3mm optics. Furthermore, it avoided certain complications that are inherent to clip usage, such as clip migration off the cystic artery, causing hemorrhage or off the cystic duct, causing bile leakage. In addition, clips that moved to the duodenum or the hepatic duct causing duct obstruction have also been described.
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2. Carvalho GL, Silva FW, Bonin EA, et al. New Minilaparoscopic Low Friction Needle Trocar Improves Cosmesis; Diminish Surgical Effort And Increases Dexterity For Precise Surgical Tasks.Oral presentation at 20th International Congress of the European Association for Endoscopic Surgery (EAES) Brussels, Belgium, 20–23 June 2012, Abstract OA05, Surg Endosc. 2013 – Online first - DOI 10.1007/s00464-013-2875-x
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There is no clear correlation between clip design (via different product venders), or clip delivery size (5mm instrument verssus 10-12mm instrument).
The most typical scenario, although I can't site this as the "commonest cause", is a retained common bile duct stone causing back pressure on the cystic duct stump in the early post operative period (1-7 days). Second, would be an acute cholecystitis case, with significant edema around the duct.
CD stump leak is no longer classified as a "major bile duct injury", and a vast majority of these cases can be handled non-surgically via ERCP--guided CBD stenting---which is then removed 4-6 weeks later.
I personally believe some of these so blamed "cystic duct stump leak" are missed minor breach in the biliary passage. These are missed because they are not visible on the table itself. They are usually energy insults resulting in coagulative necrosis which sheds off after 24 hours or more. The energy insults are not looked for as energy is not visible & travels beyond the visible. I have conviction in these being related to 'energised dissection' (ED). I continue to be a helpless witness of most of these being unreported & patronizingly salvaged by gastroenterologist colleagues. I continue to do laparoscopic cholecystectomy without ED, in all my cases without any exclusion with a zero "adverse event' outcome so far. It is not to say that adverse events will remain never events with me but certainly avoiding ED is helpful. It also brings to my mind another question raised on this forum "surgical myths'. A similar myth is " a surgeon claiming to be zero risk rate is either lying or hasn't operated much' It is because of this perception that i don't publish my outcomes.
From my point of view most common cause of bile leakage after LCE is high pressure in common bile duct. The reasons for this could be benign or malignant strictures, stenoses or residual stones of CBD. The type of the clips is the least impact on the development of bile leakage.
There are no bile leakage after removal of holedohostomy drains under normal pressure level in the CBD.
I think that the most common cause of bile leakage is technical failure due to clip material or surgeon mistake. In difficult situations like wide cystic duct you could decide on alternative devices like hemolock or stapler (in case of wide cystic duct in a severe acute cholecystitis)
I'm agree with dr Carvalho that ligating by knot the cistic duct could reduce the cost, but I think that "clip method" is safer because is fit for all surgeons (from trainee at the first lap chole to the senior consultant surgeon) and it doesn't require any supplementary skill like knot tying.
I think I have much less experience than experts like you, but I would like to share my experiece. In the facility I'm working, only metal clip is available as a clipping device, but there is no detectale cystic stump leak in my series of more than 300 SILS cholecystectomy. My opinion is using right clipping device in an appropriate situation without technical error is enough for cystic duct security. In addition to high pressure of CBD, overstretching of cystic duct during clipping (short cystic duct stumoe, wrong clipping position or poor clipping angle), energy damage of cystic duct stump, inflammatory induration of cystic duct is a major cause of loosening of metal clipping. Hemoloc would be a good solution or knot tying would be necessary, although it is technique demanding. In my experience, I always checked clip loosening (clip bending, clip corssing, clip overlapping, etc.) after clipping and replaced them as needed. If good clipping failed after 2-3 attempts, knot tying (one is enough) would be done.
There would appear to be little doubt that metal clips can be conducive to cystic duct leaks. I recognised this and reported it as far back as 1995 when automated metal clippers were not available to us . Where the automated metal clippers superseded the hand held manual applicators the clips were still metal and this has not resolved the problem. [Br J Surg 1995 [Nov] 82[1]:1543. All the respondents seem to be in accord on this and in fact there is good evidence to support the use of absorbable locking clips. [Surg Endos. 2006 Jun 20[6] 875-7 & Am J Surg 2012 Nov 78[11] 1228-31.
All the hypotheses proposed have some merit especially the difference between the LC's done in the acute state where the cystic duct is oedematous and more friable
and alternative skills need to be available under those circumstances such as careful application of suture material using endoloops or with direct suturing. Both can be challenging under the circumstances.
I am not sure there will a single step in preventing this complication and where we might reduce the incidence of this complication it will still occur regardless of the technique employed.
Therefore the most important element is the early recognition of the bile leak and after MR confirmation that there is no CBD calculus or I personally recommend that a repeat laparoscopy is mandatory and when performed early the site of the leak is often recognizable and the problem can be addressed on its individual merit. The approaches range from simple wash out and passive drainage to reapplication of a clip/suture plus or minus tissue glue. Always be cognisant of the possibility of an inadvertent bile duct injury.
Often this can prevent the necessity for Endoscopic Sphincterotomy and stent insertion which is not without its own morbidity and mortality.
I think that the cystic stump leakage is mitifoctoral issue depends on the patient condition( acute cholecystic,or CBD hight pressuer) and experience of the surgeon , in case of acute situiation we should pay attention to put a large clipp to over come the subside the odeoma of the duct after 2-3 days after inflmmation come down, also we should put in mind the intaor extracorporial knote if the duct so inflammed and dilated . any case with suspected stone in CBD should be do ERCP and sphinctertomy preoperative to decrease the CBD pressure , to my experience with more trhan 5000 Lap. cholecystectomies applied these rules you will have zero % of the cystic duct leakage
very interesting discussion everybody put forward very relavent points.I have a modest experience of more than 30000 cases as we i started the programme in 1992 at Apollo hospital,Chennai india.Retained cbd stones mentioned but our experience differs-jaundice is more common than leaks .Injury during dissection,cautery burn,severly inflammed duct and impropr ligation are commonproblems.Leave it be clipps,ties,sutures or as a matter of fact self locking vascular clips leaks can occur.The reasons are necrosis at duct or slippage as the edema regresses.we have been using ultrasonic devise for dissection and self locking clipps.These alone are not fool proof but safer in difficult cicumstances.Role of surgery is rare-ERCP and u/s guided drainage are the minimally invasive modalities.
The clips displacement due to the high CBD pressure is just another surgical myth. Being put on the normal cystic tissue the clips can hold up to 300 mm Hg that is the upper limit of the secretory pressure of the liver.
The clippage or ligation can both be complicated with the stump leakage so that these modalities do not matter, I remember 'the age of ligation' clearly, I was a beginner that time.
I am agree with previous colleagues in that that there are two major causes of the clips displacement from the cystic stump:
1) improper technique of the operator (incomplete dissection, too short stump, too closed to the brim of the stump, improper fixation, too wide the stump that demands another technique, etc.)
2) the clips put on the stump containing tissue of doubtful vitality or frank necrosis that is the proper technique as well.
Besides, there may be cases of the 'faulse' stump leakage:
for example, the clips was put on a fold of the cystic duct so that there a gap left lower to the clips; the ruptures of the junction of the cystic and the common duct, etc.
I think Jose's comment is the most comprehensive. Below a bit on this topic.
Methods of cystic duct occlusion during laparoscopic cholecystectomy.http://www.ncbi.nlm.nih.gov/pubmed/20927751
Endoscopic therapy for bile leak based on a new classification: results in 207 patients. http://www.giejournal.org/article/S0016-5107(04)01892-9/abstract
Post-cholecystectomy cystic duct stump leak: a preventable morbidity. http://onlinelibrary.wiley.com/doi/10.1111/j.1751-2980.2009.00387.x/pdf