3
NHS NW London Planned Procedures with a Threshold Policy. Version 2 (August 2011) Is this the latest version? Check here: http://www.northwestlondon.nhs.uk NHS NWL will not routinely fund cholecystectomy for asymptomatic gallstones because the risks of prophylactic cholecystectomy outweighing the benefits (grade B). Exceptions to this policy could include patients with asymptomatic gallstones AND: Sickle cell disease Calcified 'porcelain' gallbladder or a family history of gallbladder carcinoma immunosuppression, as they would be at higher risk if they develop an infective complication i.e. cholecystitis or cholangitis. Undergoing abdominal surgery for another indication Policy Asymptomatic Gallstones Gallstones (cholelithiasis) are a common condition. Asymptomatic gallstones are gallstones detected incidentally in patients who do not have any abdominal symptoms or have symptoms that are not thought to be due to gallstones. Diagnosis is usually made during routine ultrasound for other abdominal conditions. The standard treatment for patients with symptoms or gallbladder inflammation caused by gallstones is cholecystectomy (surgical removal of the gallbladder). However, this is not necessarily the best policy for those with asymptomatic gallstones. Evidence Base The natural history of asymptomatic gallstones is such that serious symptoms and complications only develop in about 1% to 2% of patients annually, with fewer complications developing in later years (Friedman GD, 1993). The cumulative risk of needing treatment during the first 5 years after detection of asymptomatic gallstones is 7.6% (Halldestam I et al, 2004). A recent Cochrane Review concluded that only patients with symptomatic gallstones need treatment because complications in elective cholecystectomy are high, with rates of around 17% for all three surgical techniques (Keus F et al, 2010). However, concomitant cholecystectomy could be a reasonable option for good-risk patients with asymptomatic cholelithiasis undergoing abdominal surgery for unrelated conditions (Sakorafas GH, 2007). Several clinical guidelines including The World Gastroenterology Organisation (WGO) Practice Guidelines do not recommend cholecystectomy in patients with asymptomatic gallstones or those with one attack of uncomplicated gallstone pain because the risks of the operation outweigh the complications if the stones are left alone. The WGO Guidelines identified the following subgroup of patients as possible exceptions: patients with immunosuppression as they may have a higher risk should they develop a complication such as cholangitis, patients with rapid weight loss, weight cyclers and those with higher risks of complications generally, and patients with calcified 'porcelain' gallbladder as these are also at high risk of evolving into cancer. Patients with insulin-dependent diabetes do not have a higher prevalence of stones, but when elderly, have a higher risk should they develop inflammatory complications (WGO Guidelines, 2006-8). Summary Low risk of complications from asymptomatic gallstone disease (level 1b) Complications from elective cholecystectomy are high (level 1a) Some subpopulations with asymptomatic disease are at higher risk of complications. The risk benefit calculations are as follows: out of 10,000 patients with asymptomatic stones,15 patients will die from gallstone complications over 10 years. If all 10,000 had surgery, 10 to 50 would die from complications of the surgery. The follow up deaths are spread over 10 years, whereas the operative deaths would occur immediately (WGO guidelines). Background

5 Asymptomatic Gallstones

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Page 1: 5 Asymptomatic Gallstones

NHS NW London Planned Procedures with a Threshold Policy. Version 2 (August 2011)

Is this the latest version? Check here: http://www.northwestlondon.nhs.uk

NHS NWL will not routinely fund cholecystectomy for asymptomatic gallstones because the risks of prophylactic cholecystectomy outweighing the benefits (grade B).

Exceptions to this policy could include patients with asymptomatic gallstones AND:

Sickle cell disease

Calcified 'porcelain' gallbladder or a family history of gallbladder carcinoma immunosuppression, as they would be at higher risk if they develop an infective complication i.e. cholecystitis or cholangitis.

Undergoing abdominal surgery for another indication

Policy

Asymptomatic Gallstones

Gallstones (cholelithiasis) are a common condition. Asymptomatic gallstones are gallstones detected incidentally in patients who do not have any abdominal symptoms or have symptoms that are not thought to be due to gallstones. Diagnosis is usually made during routine ultrasound for other abdominal conditions. The standard treatment for patients with symptoms or gallbladder inflammation caused by gallstones is cholecystectomy (surgical removal of the gallbladder). However, this is not necessarily the best policy for those with asymptomatic gallstones. Evidence Base

The natural history of asymptomatic gallstones is such that serious symptoms and complications only develop in about 1% to 2% of patients annually, with fewer complications developing in later years (Friedman GD, 1993). The cumulative risk of needing treatment during the first 5 years after detection of asymptomatic gallstones is 7.6% (Halldestam I et al, 2004). A recent Cochrane Review concluded that only patients with symptomatic gallstones need treatment because complications in elective cholecystectomy are high, with rates of around 17% for all three surgical techniques (Keus F et al, 2010). However, concomitant cholecystectomy could be a reasonable option for good-risk patients with asymptomatic cholelithiasis undergoing abdominal surgery for unrelated conditions (Sakorafas GH, 2007).

Several clinical guidelines including The World Gastroenterology Organisation (WGO) Practice Guidelines do not recommend cholecystectomy in patients with asymptomatic gallstones or those with one attack of uncomplicated gallstone pain because the risks of the operation outweigh the complications if the stones are left alone. The WGO Guidelines identified the following subgroup of patients as possible exceptions: patients with immunosuppression as they may have a higher risk should they develop a complication such as cholangitis, patients with rapid weight loss, weight cyclers and those with higher risks of complications generally, and patients with calcified 'porcelain' gallbladder as these are also at high risk of evolving into cancer. Patients with insulin-dependent diabetes do not have a higher prevalence of stones, but when elderly, have a higher risk should they develop inflammatory complications (WGO Guidelines, 2006-8). Summary • Low risk of complications from asymptomatic gallstone disease (level 1b)

• Complications from elective cholecystectomy are high (level 1a)

• Some subpopulations with asymptomatic disease are at higher risk of complications. The risk benefit calculations are as follows: out of 10,000 patients with asymptomatic stones,15 patients will die from gallstone complications over 10 years. If all 10,000 had surgery, 10 to 50 would die from complications of the surgery. The follow up deaths are spread over 10 years, whereas the operative deaths would occur immediately (WGO guidelines).

Background

Page 2: 5 Asymptomatic Gallstones

NHS NW London Planned Procedures with a Threshold Policy. Version 2 (August 2011)

Is this the latest version? Check here: http://www.northwestlondon.nhs.uk

Link to patient information http://www.patient.co.uk/doctor/Gallstones-and-Cholecystitis.htm References 1. Friedman GD. Natural history of asymptomatic and symptomatic gallstones. Am J Surg. 1993

Apr;165(4):399-404. 2. Halldestam I, Enell EL, Kullman E, Borch K. Development of symptoms and complications in individuals

with asymptomatic gallstones. British Journal of Surgery. 2004;91(6):734-8 3. Keus F, Gooszen HG, van Laarhoven CJHM. Open, small-incision, or laparoscopic cholecystectomy for

patients with symptomatic cholecystolithiasis. An overview of Cochrane Hepato-Biliary Group reviews. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD008318. DOI:10.1002/14651858.CD008318.

4. Gurusamy KS, Samraj K. Cholecystectomy for patients with silent gallstones. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD006230. DOI: 10.1002/14651858.CD006230.pub2.

5. Sakorafas GH, Milingos D, Peros G. Asymptomatic Cholelithiasis: Is Cholecystectomy Really Needed? A Critical Reappraisal 15 Years After the Introduction of Laparoscopic Cholecystectomy. Dig Dis Sci 2007;52(5):1313-25.

6. WGO Practice Guideline: Asymptomatic Gallstone Disease. World Gastroenterology Organisation, 2006-8. 7. Gallstones-treatment in adults. Clinical practice guidelines & protocols in British Columbia, July 2007. 8. Map of Medicine 9. Comparative policies (other NHS organisations):

• NHS County Derbyshire & Derby City: not funded. No exceptions.

• NHS North Staffordshire: not funded. No exceptions.

• NHS Great Yarmouth and Waveney: not funded. No exceptions.

• NHS North East: Prophylactic cholecystectomy is not indicated in most patients with asymptomatic

gallstones (Code: K80.2). Possible exceptions include patients who are at increased risk for gallbladder carcinoma or gallstone complications.

References

ICD10 Codes OPCS Codes

K810 J188

K801 J184

K802 J185

K805 J185

K811 J185

K802 J181

K819 J181

K802 J182

D135 J183

K800 J183

K801 J183

K802 J183

K803 J183

Diagnostic and Procedure Codes

Page 3: 5 Asymptomatic Gallstones

NHS NW London Planned Procedures with a Threshold Policy. Version 2 (August 2011)

Is this the latest version? Check here: http://www.northwestlondon.nhs.uk

ICD10 Codes OPCS Codes

K810 J188

K801 J184

K802 J185

K805 J185

K811 J185

K802 J181

K819 J181

K802 J182

D135 J183

K800 J183

K801 J183

K802 J183

K803 J183

R101 J183

T810 J183

T813 J183

K801 J189

K802 J189

K811 J189

Diagnostic and Procedure Codes