Gallstone disease: diagnosis and management

This guideline covers diagnosing and managing gallstone disease in adults. It aims to reduce variation in care by promoting the most effective treatments, and to improve the advice given to people with gallstone disease before and after treatment.

# Introduction
Gallstone disease occurs when hard fatty or mineral deposits (gallstones) form in the gallbladder. Approximately 15% of the adult population are thought to have gallstone disease, and most of these people experience no symptoms. For a small proportion of people with gallstone disease, the stones irritate the gallbladder or block part of the biliary system, and this can cause symptoms such as pain, infection and inflammation. If these symptoms are left untreated, gallstones can cause more serious and in some cases lifethreatening conditions such as cholecystitis, cholangitis, pancreatitis and jaundice.
There is variation in how gallstone disease is managed. Some people with symptomless gallstone disease are offered treatment to prevent symptoms developing in the future, whereas others are offered a watchandwait approach. When people experience symptoms of gallstone disease they often need surgery to remove their gallbladder. There is uncertainty about the best way of treating gallstone disease. In addition, if surgery is appropriate there is uncertainty about whether it should be performed as soon as possible after a gallstones attack or delayed until any infection and inflammation has subsided.
This guideline addresses some of these uncertainties and provides recommendations about how gallstone disease should be identified, diagnosed and managed in adults.# Recommendations
People have the right to be involved in discussions and make informed decisions about their care, as described in making decisions about your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

# Diagnosing gallstone disease
Offer liver function tests and ultrasound to people with suspected gallstone disease, and to people with abdominal or gastrointestinal symptoms that have been unresponsive to previous management.
Consider magnetic resonance cholangiopancreatography (MRCP) if ultrasound has not detected common bile duct stones but the:
bile duct is dilated and/or
liver function test results are abnormal.
Consider endoscopic ultrasound (EUS) if MRCP does not allow a diagnosis to be made.
Refer people for further investigations if conditions other than gallstone disease are suspected.

# Managing gallbladder stones
Reassure people with asymptomatic gallbladder stones found in a normal gallbladder and normal biliary tree that they do not need treatment unless they develop symptoms.
Offer laparoscopic cholecystectomy to people diagnosed with symptomatic gallbladder stones.
Offer daycase laparoscopic cholecystectomy for people having it as an elective planned procedure, unless their circumstances or clinical condition make an inpatient stay necessary.
Offer early laparoscopic cholecystectomy (to be carried out within 1 week of diagnosis) to people with acute cholecystitis.
Offer percutaneous cholecystostomy to manage gallbladder empyema when:
surgery is contraindicated at presentation and
conservative management is unsuccessful.
Reconsider laparoscopic cholecystectomy for people who have had percutaneous cholecystostomy once they are well enough for surgery.

# Managing common bile duct stones
Offer bile duct clearance and laparoscopic cholecystectomy to people with symptomatic or asymptomatic common bile duct stones.
Clear the bile duct:
surgically at the time of laparoscopic cholecystectomy or
with endoscopic retrograde cholangiopancreatography (ERCP) before or at the time of laparoscopic cholecystectomy.
If the bile duct cannot be cleared with ERCP, use biliary stenting to achieve biliary drainage only as a temporary measure until definitive endoscopic or surgical clearance.
Use the lowestcost option suitable for the clinical situation when choosing between daycase and inpatient procedures for elective ERCP.

# Patient, family member and carer information
Advise people to avoid food and drink that triggers their symptoms until they have their gallbladder or gallstones removed.
Advise people that they should not need to avoid food and drink that triggered their symptoms after they have their gallbladder or gallstones removed.
Advise people to seek further advice from their GP if eating or drinking triggers existing symptoms or causes new symptoms to develop after they have recovered from having their gallbladder or gallstones removed.

# Terms used in this guideline

## Asymptomatic gallstones/ asymptomatic common bile duct stones
Stones that are found incidentally, as a result of imaging investigations unrelated to gallstone disease in people who have been completely symptom free for at least 12 months before diagnosis.

## Gallbladder empyema
Buildup of pus in the gallbladder, as a result of a blocked cystic duct.

## Laparoscopic cholecystectomy
Removal of the gallbladder through 'keyhole' surgery.

## Percutaneous cholecystostomy
A procedure to drain pus and fluid from an infected gallbladder.

## Symptomatic gallstones/ symptomatic common bile duct stones
Stones found on gallbladder imaging, regardless of whether symptoms are being experienced currently or whether they occurred sometime in the 12 months before diagnosis.# Research recommendations
The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

# Diagnosing gallstone disease
What are the longterm benefits and harms, and cost effectiveness of endoscopic ultrasound (EUS) compared with magnetic resonance cholangiopancreatography (MRCP) in adults with suspected common bile duct stones?
Why this is important
MRCP and EUS have both been found to be sufficiently accurate for diagnosing common bile duct stones, with EUS regarded as the most accurate test. MRCP is noninvasive and so carries negligible risks to the patient. However, EUS carries a small but significant risk of patient harms, including death. There is insufficient evidence available to determine whether the benefits of improved diagnosis associated with EUS outweigh its procedural risks. Therefore, research is needed to compare MRCP with EUS to evaluate the subsequent management of common bile duct stones.

# Managing gallbladder stones
What are the benefits and harms, and cost effectiveness of routine intraoperative cholangiography in people with low to intermediate risk of common bile duct stones?
Why this is important
In the evidence reviewed for this guideline, there was a lack of randomised controlled trials of intraoperative cholangiography, and the evidence that was available did not support the knowledge and experience of the Guideline Development Group. Therefore, there is a need for large, highquality trials to address clinical questions about the benefits and harms of intraoperative cholangiography.

# Managing common bile duct stones
What models of service delivery enable intraoperative endoscopic retrograde cholangiopancreatography (ERCP) for bile duct clearance to be delivered within the NHS? What are the costs and benefits of different models of service delivery?
Why this is important
Evidence reviewed for this guideline identified that intraoperative ERCP is both clinically and cost effective, but it is unclear whether delivery of this intervention is feasible in the NHS because of the way current services are organised. It is also unclear whether intraoperative ERCP will remain cost effective if services are reorganised.

# Timing of laparoscopic cholecystectomy
In adults with common bile duct stones, should laparoscopic cholecystectomy be performed early (within 2 weeks of bile duct clearance), or should it be delayed (until 6 weeks after bile duct clearance)?
Why this is important
There is a lack of evidence from randomised controlled trials of early compared with delayed laparoscopic cholecystectomy after bile duct clearance with ERCP. It is unclear what effect the timing of laparoscopic cholecystectomy has on clinical outcomes and resource use.

# Information for patients and carers
What is the longterm effect of laparoscopic cholecystectomy on outcomes that are important to patients?
Why this is important
There is a lack of information on the longterm impact of cholecystectomy on patient outcomes. Many patients report a continuation of symptoms or the onset of new symptoms after laparoscopic cholecystectomy, and these affect quality of life. Research is needed to establish the longterm patient benefits and harms, so that appropriate information can be provided to patients to aid decisionmaking and longterm management of their condition.