When reading this, remember the author is NOT a Doctor! He is a well-intentioned and well researched individual (about ERCP) who is funding the web-site out of private means. His experience is that the vetting of patients for ERCP is likely to be inadequate in many NHS hospitals, resulting in a high level of unnecessary ERCP. This checklist is designed to help patients assess their need for ERCP by priming them to the sort of questions they need to be asking. The questions are particularly appropriate for patients told they have a stone in their common bile duct.
To ask yourself:
- Am I jaundiced?
If you are, it is a sign you are quite likely to have a CBD obstruction and therefore may need ERCP. If you do not have jaundice it implies you have no obstruction (or no serious one), which is a good indication you may not need ERCP.
- Do I have a fever?
A fever is a sign of infection. Obstructions, typically caused by gallstones, within your CBD can lead to potentially serious infections such as cholangitis and pancreatitis. Do your own research to try and ascertain if your fever is consistent with either of these conditions (what other symptoms do you have? how long have you had the fever? is the fever likely to have another cause?). If ERCP is offered, I suggest you have the following thoughts: ERCP alone will not stop an infection but ERCP can help if it has a clear therapeutic purpose: to clear an obstruction that is leading to a sustained infection. The question then is: how clear is the evidence for an obstruction? If the evidence is not convincing, there is a good argument for being cautious and just treating the infection with antibiotics. It is a case of balancing the risks of ERCP versus the benefit of being able to remove the cause of an infection.
- Are my stools yellow / grey?
Gallstones can cause yellow / grey stools, as they may block the function of the gallbladder: so it can't supply the usual volume of (brown) bile and Bilirubin to your digestive system when you eat. However, there can be many other causes, including common infections and stress.
The lesson I have learnt is that if you have had one such episode, or even repeated occasional episodes, then as regards your need for ERCP, little weight should be placed on this evidence in the absence of any other more conclusive recent symptoms. Even if your pale stools are in fact related to gallstones, it would mean you are occasionally creating and passing them successfully without intervention. I would suggest extreme caution in considering this symptom a strong indicator for ERCP. There is a good chance no stone will be found at the time of ERCP and you will have risked your life for no good reason.
- Apart from any imaging evidence, is pain my main symptom?
Biliary Colic pain is an indicator of Gallstones. This can be painful, particularly when gallstones try to pass from the gall-bladder into the CBD, or when they become impacted trying to get out of your CBD. Do your research to learn how to identify such pain and check if your pain is consistent with this (check your Murphy's sign!). Biliary Colic is often experienced after meals as the gallbladder tries to contract in order to force out bile to aid digestion.
There can be many causes of abdominal pain and some can be difficult to diagnose. Keep a diary of your pain episodes to help with diagnosis. Be wary of having ERCP just to rule out CBD stones or other issues with your CBD. There will be a high risk of ERCP futility and unnecessary exposure to risk. Always favor non-invasive testing or scanning over invasive procedures like ERCP. If your pains are particularly persistent and troublesome and you have no other symptoms of CBD stones, you could raise the idea of an abdominal CAT scan. This is a particularly effective diagnostic tool, but does carry a longer term risk from the X-Ray exposure. You can arrange for one privately if necessary.
- Have any symptoms I've had previously, ceased?
This includes jaundice, yellow stools, pain, etc. If no such symptoms remain, it means any CBD stone you may have had, has probably been passed. I would suggest this is a strong indicator that you do not need ERCP and that you should not stand the risk of having it just as 'a check'!
To ask your doctor:
- Do I have gallstones currently showing in my gall-bladder?
It is reckoned 85% of patients with stones in their CBD will also have gallstones in their gall-bladder: where most of them originate from. It is also easy, and quite reliable, to identify the presence or absence of gallstones in the gallbladder by ultrasound or MRCP. Further, it is estimated only 10% of patients with symptomatic gallstones in their gallbladder will also have stones in their CBD. See this reference:
I read this as follows: If you have been told you do not have stones in your gallbladder, you should be wary of any CBD stone diagnosis: it really would be very unlikely! (If anyone wants to challenge me on this, then please send me the clinical evidence!). Even if you have stones in your gallbladder, there still only appears to be a 10% chance you'll also have one stuck in your CBD.
Many doctors will want to remove your gallbladder if you have gallstones in it. Some will want to refer you for ERCP first: to remove any stones in your CBD before your cholecystectomy. Others will only recommend ERCP after a cholecystectomy: if you still have symptoms of CBD stones a few weeks after surgery. Discuss the strategy carefully with your doctor. The latter approach appears to be the safer option as you are not exposed to the additional risks of ERCP, when this may prove unnecessary. During the gallbladder removal operation, the surgeon will have access to your CBD and can investigate and potentially 'trawl' this to remove any stones still in there at that time. Read up on 'Intraoperative Cholangiograms'.
The report below identifies that the likelihood of stones being in the CBD at the time of cholecystectomy is unlikely to exceed 5%.
http://www.bsg.org.uk/attachments/127_cbds_08.pdf
My thoughts are: why subject yourself to two sets of risks when one might do? In the 5% of cases where a stone is left behind in the CBD, many are likely to pass out unaided subsequently. Ask what clinical evidence supports the recommendation you are being given.
- Do I presently have raised Liver Function Test (LFT) results?
This type of Blood test is very important. If your common bile duct is blocked / restricted this will affect your liver and the signs will appear in your LFT results (raised Bilirubin etc). If you do not have raised LFT levels, this is a very important indicator that you may well not have a CBD stone.
- Is the wall of my gall-bladder thickened?
If yes, this is an indicator that you may be, or have previously been, creating and passing gallstones. If not, it means there is no indicator for this and means it is less likely you'll have a CBD stone. If, however you do have some thickening, then it means you may nevertheless have been creating and passing stones successfully. If so I suggest you consider what your chances are of passing any further stone which you may have had diagnosed in your CBD.
- Does my common bile duct show any dilation?
If this is reported it increases the chances of a CBD stone diagnosis being correct: as clearly there is likely to be something internal to it causing the dilation. Larger CBD stones like this may have less chance of being spontaneously 'passed out' and have more chance of becoming impacted and causing serious infections such as cholangitis or pancreatitis.
If there is no dilation, it reduces the chances of a CBD stone diagnosis being correct and reduces the chances (even if it was correct) of one being found at the time of ERCP. This is particularly the case if you have a small diameter CBD (4mm or less): as small CBD stones are less easy to diagnose reliably and are easier to pass naturally. Note: smaller objects cast a smaller and fainter 'shadow' (if any at all) on ultrasound. A good shadow acts as a good confirmation of gallstones.
Should you have no dilation, but still in fact have a CBD stone, it means the stone is small enough to probably have free movement within the CBD and be allowing the free passage of bile around it (so you may also not have raised LFT's or any jaundice). A small stone will also have more chance of spontaneously passing out of your CBD into your duodenum without causing an impaction or infection. This (to me) indicates that for such stones, the need for ERCP is highly questionable. Doctors may warn that such small stones may cause cholangitis (infection of the biliary tract) or (by entering the pancreatic duct) cause pancreatitis, but they will not be able to tell you the chances of this happening! Remember ERCP itself can be the cause of cholangitis and it also has a high (1 in 20) chance of causing pancreatitis!
-What size is my common bile duct?
A smaller duct means increased risk from ERCP. Why? Because if a precut is necessary (and you won't know this in advance), the surgeon is aiming for a smaller target as he burns through with the needle-knife. In other words, he's more likely to miss his target. I believe CBD diameters can vary from 3 to 10 mm, but 4mm is quite normal in people who have not had a cholecystectomy.
There is clinical evidence for this:
http://informahealthcare.com/doi/abs/10.3109/00365521.2014.898085
-Is the evidence (e.g. from earlier scans / blood tests) still strong evidence of the problem still being present?
If you feel better and are largely symptom free this is a strong indicator for caution: your problem (stone) may have passed! I suggest you don't subject yourself to ERCP if you suspect the problem has passed. ERCP should not be used as a diagnostic /checking tool.
- Can you show me my scan reports?
This is very important! Ask the doctor to show you all the scan reports (ultrasound / MRCP etc). READ THEM YOURSELF CAREFULLY! (even photograph them to study again later). Your doctor is highly unlikely to have reviewed any images from such scans himself, so he is relying on a radiologists interpretation. Is he reading the reports in the same way as you would?
The radiologist will also be unaware of how much weight will be attached to his report subsequently. If imaging evidence is the only or main source of evidence for a continuing problem, I strongly suggest you insist that your scans be referred for a second opinion with a request that the new report identifies all other possible diagnoses and their likelihood. Be particularly wary if the report says there is a small 'stone' or the like which measures 5 mm or less. The accuracy of diagnosis in these circumstances is significantly less than 100%.
- Can you explain how you are interpreting evidence
Always challenge your doctor to explain WHY he / she is discarding any evidence or discarding the absence of certain symptoms (as mentioned above)!
If you have time, I consider this report below to be a very important, well researched document concerning the management of CBD stones. Read this if you want to try and understand what ‘best practice’ means for managing CBD stones. Chances are, once you have done so, you will know just as much as your doctor!
http://www.bsg.org.uk/attachments/127_cbds_08.pdf
Section 7.1 on page 1007 is particularly worth a read. It illustrates the need to take a number of indicators into account in order to increase the reliability of CBD stone diagnosis.
Don't be persuaded that because an earlier ultrasound scan showed 'something' that it reinforces the chances of a CBD stone diagnosis on a later MRCP being correct. In my view it does not. Read my ‘considerations’ section: the paragraph on missed / over diagnosis.
Don't forget also to consider the elapsed time between your scans, LFT tests and your ERCP date. You must consider whether your body has naturally passed a 'possible' stone that showed up on a scan many weeks previous! Have your symptoms gone or eased since? If so this is, I would suggest, a strong contra-indicator for ERCP even if you have positive scan results.
Note: if you are told that normal LFTs and the absence of any jaundice or CBD dilation does not mean you do not have a CBD stone, be suspicious! Whilst you could still have a CBD stone, it is statistically much less 'likely'. Your doctor may be one of those looking for reasons to treat and be willfully / ignorantly ignoring reasons not to treat.
- Have all my scan images been reviewed in this Hospital?
Were all the scans made in the hospital where you have been referred? and have they all been reviewed in this hospital? If (as is common these days) an initial ultrasound scan was done in a community health centre prior to referral, were the images from this requested (as they can be) for review? Although doing so will help protect you from misdiagnosis, many doctors will not bother: as it will cost them time!
Don’t forget, if you identify the provider who did the scan you can request from them a copy of it on CD, which you can then simply hand over (but keep a copy!). Don’t expect this ‘involvement’ to be welcomed however. It is my honest opinion however that this practice, if universally adopted, would reduce the incidence of unnecessary ERCP and the consequential death rate.
- Should any tests be repeated?
This is particularly important if a long time has elapsed since they were done. Our bodies are remarkably able to heal themselves and overcome problems, given time. Don't intervene if you feel your body is resolving a problem naturally. Read up on what causes gallstones: you may be able to do a lot of self-help.
- Can you arrange for an Endoscopic ultrasound test before ERCP?
This is an invasive test like ERCP, so carries some risk, but a much lower risk than ERCP as there is no therapeutic (treatment) element to it. An endoscope is inserted into your duodenum from where it can scan for CBD stones in a much more sensitive way than external ultrasound. Like with any ultrasound scan, the consultant is driving the instrument as he views the images, so is able to reposition in order to 'explore' any object. Any stone will be much closer to the scanner, which greatly increases the sensitivity. In my view this technology is unlikely to confuse a blood vessel with a CBD stone or air pocket like MRCP can.
If the only evidence for a CBD stone is an earlier ultrasound and / or MRCP scan, then I would strongly suggest you ask for an endoscopic ultrasound before committing to ERCP. Please take into account the next point (below) also. Be prepared to learn however that your Hospital cannot provide this service. In that case I would go back to your GP and check if he / she can arrange such a test at another Hospital. Be awkward! Your chances of coming out alive and well depend on getting as reliable a diagnosis as you can! ERCP should not be performed if there is any doubt about your need for it.
- Will the Hospital be able to repair any perforation using clips inserted via an endoscope?
If you suffer a perforation, this will be extremely serious. In this situation if the Hospital has the ability to place clips over the perforation via an endoscope, this will be the safest and most effective way to repair the damage and potentially save your life. However not all Hospitals have surgeons and/or the instruments to do this. If you suffer such an injury and this type of repair is not possible, you will be much more likely to need highly invasive conventional surgery which carries a high risk of serious complications. If such techniques are not available at your Hospital, I would again suggest you try and look elsewhere for your ERCP.
- How many doctors do you have who undertake ERCP?
- How many ERCP procedures does the Hospital undertake every year?
From these two facts one can work out how many on average each performs. Any surgeon doing under 50 ERCP procedures per annum is considered more at risk of higher failure rates (because they're not maintaining their skills adequately). I read that about 11% of ERCP procedures are carried out by doctors doing less than 50 per year.
- What percentage of ERCP procedures require a precut?
Please ensure you read the page: 'ERCP hidden facts'. Precuts are a controversial procedure that some ERCPists avoid altogether, as it carries serious risks to the patient (it's what led to my partner's death). If you are told that NO precuts are done, this should be very reassuring to you. When precuts are performed, I understand it would be typical for 10% of patients to undergo this. If the actual rate is much higher than this, I would suggest this is an indicator of poor skills and high risk. If my experience is anything to go by, you'll not be told the figure! I suggest you assume the worst and think about going elsewhere.
- What is the risk of perforation?
All facts like this will be audited (how else would they know what to put on a consent form for example?). If the doctor cannot tell you it implies he / she is unqualified enough (in my view) to adequately inform you for the purpose of gaining your consent. It may be of course that he / she doesn't want you to know! Either way I suggest you be wary of evasive answers. A 1% figure would not be unusual. As precuts are a major cause of perforations, the typical figures used here would indicate a typical 1 in 10 perforation risk with precuts.
- Does the hospital have a care plan to follow should I receive a perforation? In particular, will I receive endoscopic naso-biliary drainage (ENBD); will I be assessed by a Consultant Microbiologist; will I be monitored hourly in an ITU environment?
If the answer is "yes" on all counts this should be hugely reassuring to you! This means the Hospital is working to 'best practice' by international standards. You will stand a much higher chance of surviving a perforation. If they don't, but say they would immediately transfer you to another - better equipped - Hospital this should also be reassuring (to a degree).
If the answer is "no" to all these (as is most likely I suspect, for most NHS hospitals) I would suggest you really need to think: how lucky will I be? Because to be brutally honest, if you suffer a perforation, your survival will depend on a great deal of luck. A care plan greatly helps ensure best practice after such an event.
You might consider going back to your GP and checking if he / she can refer you to another Hospital which is better equipped / skilled with managing serious complications post-ERCP. Ask if any hospitals will provide ENDB and are likely to have spare ITU beds.
Why is ENBD important? Our livers produce bile constantly: about 1 litre per day; our pancreas' also produce gastric juices and we swallow about 0.3 litres of saliva per day. Even though one will be NBM (nil by mouth) after a perforation, all these fluids will still be entering the duodenum. Also, during ERCP your duodenum will have been pressurized with air, to expand it (like pumping up a tyre inner-tube) in order to get the endoscope down. Any perforation will cause this high pressure air to exit into one's abdominal cavity where it will remain until gradually reabsorbed by the body over several days. During this period, before the wound has had a chance to heal over, it will not be difficult to understand (if you know your physics) how your duodenum, once filled with fluid, will easily be able to leak this through the perforation into the void behind. The pressure (like a hand over a skin puncture wound) from adjacent organs will not be there to restrict the leak. This is why (I believe) ERCP perforations are so potentially fatal. ENBD is simply the BEST type of drainage to apply: as it takes all the bile and pancreatic fluids away from the wound site. Coupled with normal NG (Naso-gastric) drainage for removing swallowed saliva from the stomach, one's body will then be given the best possible chance of recovery.
Note: NG drainage alone will reduce the amount of leakage but may not prevent it, but it is much better than nothing. You might be lucky in some hospitals however to even get that! Without drainage, leakage of such fluids into one's abdomen will instigate a huge inflammatory response which invariably triggers the onset of sepsis leading to a high probability of death.
Why is early assessment by a consultant microbiologist important? It is because you will be at high risk of developing a life threatening infection due to leakage through the perforation. Your gut will contain several types of bacteria coming under the categories of: coliforms, anaerobes and enterococci. No one antibiotic can kill all these! In my experience only a microbiology consultant can be relied upon to correctly assess the optimal mix of antibiotics needed and their dose. You may also have an antibiotic allergy that needs to be factored in. Any failure to get patients onto the optimal antibiotic regime from the earliest moment will risk bacterial colonies starting and multiplying exponentially to a point of no return potentially as soon as 36 hours after an ERCP perforation.
Do not assume that all UK NHS hospitals provide the same level of care for ERCP patients, or to the same standard as other advanced nations. The only question (for me) is how much worse the death rates in some NHS hospitals are compared to the best performing hospitals around the world. I will update this info later, but I would not be surprised to find that some institutions are 10 times better than the UK average: and that one of the main reasons will be the use of ENBD.
As I seek to encourage improvements, and encourage patients to use the safest institutions, if there are any hospitals wishing me to publish their verifiable ERCP performance stats, and other info (such as their usage of ENBD) on this website, they are more than welcome to e-mail me.
- What is the risk of pancreatitis?
Expect to hear 5% or 1 in 20. If the doctor doesn't know, he/she is not qualified (in my view) to inform you before gaining your agreement for ERCP.
- What is the risk of sepsis from ERCP?
There are 150,000 cases of sepsis in the UK every year, resulting in over 40,000 deaths; this is a staggering 22 times as many deaths as occur on our roads every year. It is a very serious condition and its incidence is closely monitored: so medics should know the risk. Be suspicious if they can't tell you.
- What is the death rate from sepsis in this Hospital?
Death from Sepsis is a very real risk; roughly 25% of septic patients will die from it. To survive it you need early recognition and top class intensive treatment, plus luck. It appears from these figures, and as I experienced, that most UK hospitals do not have a good record with diagnosing sepsis quickly and dealing with it effectively. After the onset of sepsis, every 1 hour’s delay in diagnosis and the commencement of effective treatment will reduce the chances of survival by 10%.
If you're wondering why the government wants a 24x7 NHS, I suggest you ponder these statistics and think about what would happen if you were a patient who started to go septic at midnight; on a full ward; with minimal overstretched nursing cover; no experienced doctor (consultant) available until the next morning; where the junior staff on duty were in fear of the consequences of calling anyone out of bed!
- What is the overall death rate from ERCP (where ERCP is the main cause)?
The Hospital will know this important auditable figure, but will probably not want you to know! It could be better, or more likely, worse, than the figure on the PIL. Why? because many hospitals use standard PILs produced from (presumably) national or international average figures. They then stick their letterhead on making one think these are their figures. What each Hospital's actual figures are I challenge anyone to find out! These appear closely guarded secrets.
- What is your typical occupancy rate for ITU beds?
The higher it is the less chance there'll be one available to you should you need it! This could be a life or death matter if the worst happens. This non-availability of beds is now very common in the NHS.
- Summary
If you have read all through the above, you may now realize there are many more issues for you to consider, and questions to ask, than might have occurred to you beforehand. As such, I hope this site has done its job: to inform you to the point where you now have the knowledge to assess for yourself what your best course of action is.
I predict though you will struggle to get any of your questions answered to your satisfaction, but your attempts to do so will no doubt provide you with further insights that will be helpful.
If anyone wants to join me in my campaign for improved ERCP practice, please feel free to e-mail me.