Pause...and then whip out the gallbladder
Squeezing impatiently through the waddling crowd of the unhealthy and the overweight in a hospital's corridors and stairways (and the world in general), it is astounding to remember that that the lifetime prevalence of gallstone disease is actually only about 10% to 20%. It's even more difficult to keep this at the forefront of your mind in a General Surgery outpatient clinic or On-Call, when there is barely a patient who doesn't have abdominal pain that they attribute to their inevitable gallstones! Nonetheless, I assumed that the decision making was a foregone conclusion in these patients who present with typical biliary colic and have proven stones or sludge - of course we should just whip their gallbladder out!
Whilst this bit is easy, the practical business of listing a patient for cholecystectomy is a little harder - particularly with the decimation wrought by the COVID-19 pandemic on waiting list times. Patients with uncomplicated biliary colic are extraordinarily fortunate if they get their operation within 18 months! Furthermore, in my corner of the world, the local newspapers have recently been running some uncomfortable articles on patients who have regrettably suffered bile duct injuries during cholecystectomy. My interest was therefore piqued when I came across the following article that was published recently:
Latenstein CSS et al. A Clinical Decision Tool for Selection of Patients With Symptomatic Cholelithiasis for Cholecystectomy Based on Reduction of Pain and a Pain-Free State Following Surgery. JAMA Surg. 2021 Oct 1;156(10). PMID: 34379080.
This article has been written by a Dutch collaborative group, using data from two previous trials - the SECURE[1] (2014-2017) and SUCCESS[2] (2017-2019). These trials looked to address the issue that whilst all hospitals in the Western World are seemingly overwhelmed by patients with symptomatic, but otherwise uncomplicated gallstone disease, the evidence base for how to manage these patients is actually quite limited. The initial SECURE trial was published in The Lancet in 2019[1]. The authors randomised patients to either a 'usual care' arm, where the surgeon listed patients for cholecystectomy as per their normal practice, or a 'restrictive' arm in which patients were only operated on if they met the 'ROME III Criteria'. I think that the researchers were hoping to use the optimistically-named follow up SUCCESS trial[2] to validate their approach in selecting patients who could be reasonably assigned to conservative management. However, rather dejected, they conclude that by apply these restrictions they only reduced the number of patients undergoing surgery by 7%.
Beyond the limited success of their trial however, I was horrified to read that they additionally found that 40% of patients experienced persistent abdominal pain after their surgery, regardless of a restrictive or regular policy for the indication for cholecystectomy. 40% of patients still had abdominal pain, even with their gallbladder in the bin!!! This trial therefore demonstrated not only that the Rome III Criteria is a pretty rubbish tool with which to select patients for cholecystectomy, but also more strikingly that we are not being nearly selective enough when deciding who should and who should not go under the knife. Not only are we apparently subjecting patients to operations that give them no benefit, but there are thousands more festering and suffering on waiting lists who are being denied the surgery that they deserve.
This is where the aforementioned recent article hopes to step in; by throwing the Rome III Criteria out, along with their initial research aims. Instead, they take the data prospectively collected from the 1561 patient during the two trials, and identify that patients with the following characteristics had a higher chance for a clinically relevant pain reduction after cholecystectomy:
- older patients;
- patients with no history of abdominal surgery;
- an increased baseline visual analog scale pain score;
- pain that radiation to the back;
- pain reduction with simple analgesics;
- presence of nausea;
- absence of heartburn.
They have even come up with a natty app, to help surgeons decide whether they should take out someone's gallbladder:
Reading on the above list, it's all pretty obvious and fails to shatter the Earth for me - of course the patients with symptoms more typical of biliary colic are likely to be happier bereft of their gallbladder than those presenting with vague or atypical symptoms! A surgeon may even feel their ego start to bruise a little at the implication that they need an app to hold their hand in making such a basic decision.
Bruised egos aside however, it does raise the point that perhaps we should pause for a moment of consideration before whipping out the gallbladder of every patient who combines some form of abdominal symptoms with the presence of gallstones. Even better, we should probably let patients in on this figure of 40% persistent pain before getting out the knives? An argument against this, is that it will lead to an awful lot of grumpy patients with abdominal pain that they attribute to their gallstones, as the only way to prove to a patient (or a gynaecologist) that a pain does not originate from a gallbladder, appendix or other organ is of course to chop it out!
Thankfully, there is currently another randomised controlled trial called "C-Gall" being carried out in Aberdeen, Scotland that I believe aims to pit cholecystectomy against conservative management to see what patient-reported quality of life is like, as well as the cost implications[3].
References
- van Dijk AH et al. Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial. Lancet. 2019 Jun 8;393. PMID: 31036336.
- SUCCESS Trial - https://www.trialregister.nl/trial/7069
- Ahmed I et al. Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial). BMJ Open. 2021 Mar 25;11(3). PMID: 33766835.
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