Gallstone disease (cholelithiasis) — DVA SoP factors

Reasonable Hypothesis (RH) — Statement of Principles No. 69 of 2025

At least one of the following factors must as a minimum exist before it can be said that a reasonable hypothesis has been raised connecting gallstone disease (cholelithiasis) or death from gallstone disease (cholelithiasis) with the circumstances of a person's relevant service:

1. (1)
   having a spinal cord injury at the time of clinical onset or clinical worsening;

   Note: spinal cord injury is defined in the Schedule 1 - Dictionary.

2. (2)
   having a foreign body in the biliary tract, or a mechanical obstruction of the biliary tract, before clinical onset or clinical worsening;

   Note: foreign body and mechanical obstruction of the biliary tract are defined in the Schedule 1 - Dictionary.

3. (3)
   having an ileal resection or ileal bypass within the 25 years before clinical onset or clinical worsening;
4. (4)
   having a gastric or oesophageal resection, or another operation that includes a vagotomy, within the 5 years before clinical onset or clinical worsening;
5. (5)
   having one of the following parasitic diseases of the biliary tract at the time of clinical onset or clinical worsening: (a) ascariasis; (b) clonorchiasis; (c) dicrocoeliasis; (d) fascioliasis; (e) opisthorchiasis; (f) trypanosomiasis;
6. (6)
   having bacterial infection of the biliary tract at the time of clinical onset or clinical worsening;
7. (7)
   having Helicobacter pylori infection of the biliary tract at the time of clinical onset or clinical worsening;
8. (8)
   having cholangiohepatitis or recurrent pyogenic cholangitis at the time of clinical onset or clinical worsening;
9. (9)
   having an acquired haemolytic disease, characterised by red cell defects and breakdown with bilirubin overproduction, within the 1 year before clinical onset or clinical worsening;

   Note: Examples of an acquired haemolytic disease include autoimmune haemolytic anaemia caused by infections or medications, and haemolytic uraemic syndrome caused by bacterial infection.

10. (10)
    having worsening of an inherited haemolytic disease, characterised by red cell defects and breakdown with bilirubin overproduction, within the 1 year before clinical onset or clinical worsening;

    Note: Examples of an inherited haemolytic disease include hereditary spherocytosis and sickle- cell disorder.

11. (11)
    having a somatostatinoma at the time of clinical onset or clinical worsening;

    Note: somatostatinoma is defined in the Schedule 1 - Dictionary.

12. (12)
    being pregnant within the 6 months before clinical onset or clinical worsening;
13. (13)
    for males, being obese for at least the 2 years before clinical onset or clinical worsening;

    Note: being obese is defined in the Schedule 1 - Dictionary.

14. (14)
    for females, being overweight or obese for at least the 2 years before clinical onset or clinical worsening;

    Note: being overweight or obese is defined in the Schedule 1 - Dictionary.

15. (15)
    having rapid and extreme weight loss, involving a reduction of body mass by at least 15 percent: (a) within a continuous 6 month period; or (b) at an average rate of at least 1.5 kilograms per week, and within the 2 years before clinical onset or clinical worsening;

    Note: Situations which can be associated with rapid and extreme weight loss include bariatric surgery and the use of anti-obesity medications such as glucagon-like peptide 1 receptor agonists.

16. (16)
    having a very low-calorie diet, with an energy intake of less than 800 kilocalories per day, for the 6 months before clinical onset or clinical worsening;
17. (17)
    having type 2 diabetes mellitus at the time of clinical onset or clinical worsening;

    Note: type 2 diabetes mellitus is defined in the Schedule 1 - Dictionary.

18. (18)
    having cirrhosis of the liver at the time of clinical onset or clinical worsening;
19. (19)
    having metabolic dysfunction-associated steatotic liver disease at the time of clinical onset or clinical worsening;

    Note: Metabolic dysfunction-associated steatotic liver disease was previously known as non- alcoholic fatty liver disease.

20. (20)
    having hepatitis C virus infection at the time of clinical onset or clinical worsening;
21. (21)
    having Crohn disease or ulcerative colitis at the time of clinical onset or clinical worsening;
22. (22)
    taking any of the following medications for a continuous period of at least 3 months before clinical onset or clinical worsening, and where treatment has ceased, clinical onset or clinical worsening occurred within 3 months of cessation: (a) atazanavir; (b) cyclosporine A; (c) fibrates; (d) somatostatin analogues; (e) tamoxifen;
23. (23)
    having oestrogen therapy for a continuous period of at least 3 months before clinical onset or clinical worsening, and where oestrogen therapy has ceased, clinical onset or clinical worsening occurred within 6 months of cessation;

    Note: oestrogen therapy is defined in the Schedule 1 - Dictionary.

24. (24)
    having total parenteral nutrition for a continuous period of at least 3 weeks before clinical onset or clinical worsening, and where total parenteral nutrition has ceased, clinical onset or clinical worsening occurred within 30 days of cessation;

    Note: total parenteral nutrition is defined in the Schedule 1 - Dictionary.

25. (25)
    inability to undertake any physical activity greater than 3 METs for at least the 5 years before clinical onset or clinical worsening;

    Note: MET (metabolic equivalent) is a unit of measure of the level of physical capability of the cardiorespiratory system. For example, 1 MET = cardiorespiratory effort associated with a person sitting, 3-4 METs = cardiorespiratory effort associated with a person walking at average walking pace (5 km/h) or light gardening.

26. (26)
    inability to obtain appropriate clinical management for gallstone disease (cholelithiasis) before clinical worsening;