Dec 13, 2023

Should people with gallstone problems undergo gallbladder surgery? Not too hastily!

According to a recent study and a related editorial by IQWiG’s expert Stefan Sauerland, in symptomatic gallstone disease, it may be a good idea to wait

When gallstones cause symptoms, such as colic, this is the classical indication for removal of the gallbladder. This not only relieves the acute symptoms, but also reduces the risk of complications. The main concern with gallstones is that they can slip into the bile ducts and cause blockages and severe inflammation. This can also damage the liver and pancreas.

Indication for surgery often unclear

Because gallstone disease is very common in Germany, gallbladder removal is one of the most common operations: Every year, about 175,000 men and women undergo this type of surgery – some 20 percent of patients have their gallbladder removed after their first episode of a gallstone colic. However, the exact medical indication and timing of gallbladder removal remains a grey area. Some experts advocate early surgery. But it is known that without surgery, about half of all patients would remain symptom-free for ten years.

In an editorial in the British Medical Journal (BMJ), the physician Stefan Sauerland, Head of IQWiG's Department of Non-Drug Interventions, and the surgeon Mike Ralf Langenbach, Head of the Clinic for General and Visceral Surgery and Coloproctology at the Protestant Hospital in Lippstadt, Germany, argue for cautious treatment with individual risk assessment.

C-GALL study shows little difference between surgery and watchful waiting

The editorial was prompted by a large comparative study called C-GALL. In this study, adults with uncomplicated symptomatic gallstones were randomized to either minimally invasive gallbladder removal or conservative treatment. As the results after one year for pain, quality of life and complication rates were similar in the two groups, the study authors conclude that conservative treatment is a reasonable option for patients with uncomplicated symptomatic gallstones and may even be preferable in certain patients.

This view is shared by Stefan Sauerland and Ralf Langenbach. It is true that in some cases swift removal of the gallbladder is clearly the best solution. However, depending on the individual risk factors and the patient's wishes, conservative treatment is at least worth trying for many patients. Surgery as the standard solution for gallstone disease is not a good idea, especially not for mild and atypical symptoms, as in some cases surgery does not improve symptoms. In a Dutch study, a cautious approach to treatment reduced the rate of gallbladder surgery by eight percent, without increasing the rate of complications. In any case, it is essential to make an individual decision together with the patient.

IQWiG offers a decision aid

IQWiG has already developed a decision aid for patients to help them become aware of the general and individual advantages and disadvantages of gallbladder removal. As part of a commission from the Federal Joint Committee (G-BA), the main decision-making body in the German health care system, IQWiG previously proposed that a so-called “second opinion procedure” for gallbladder removal should also be available in Germany, so that patients with doubts can seek a second medical opinion before a possible operation. Since the beginning of 2023, members of statutory health insurance funds have been entitled to this service in Germany.

Another notable aspect of the C-GALL study is that it was funded by the UK's (HTA) programme. HTA is the systematic evaluation of medical interventions. However, as a German HTA agency, IQWiG – unlike its British counterpart – has few opportunities to answer important health questions in clinical studies. Stefan Sauerland notes: "It’s a pity that we keep identifying relevant gaps in medical knowledge, but have no means of filling them."

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