Fourteen patients die in Amsterdam hospital's medical study
A medical study among patients with bile duct cancer led by Amsterdam hospital AMC was halted after 14 of the 54 participants died, AD reports.
The study, which was carried out in Amsterdam, Groningen, Maastricht and Rotterdam, started in 2013 and was terminated in 2016 due to the number of deaths. According to AD, the death rate was much higher than expected.
In the study two methods of removing excess bile from the liver were compared. Half of the participants had a bile tube inserted through the throat, the other 27 had this done through the via the skin through the liver, also called liver drainage. Three patients in the first group died, and eleven in the second group. The patients died in different stages of the treatments. Both methods have been used in healthcare for decades.
Surgeon and researcher Thomas van Gulik of AMC told AD that he is enormously surprised by both the difference between the two methods and the high number of deaths in the liver drainage method. A letter sent to the participants state that it is still not clear why so many more people died in this method than in the other one. Van Gulik told the newspaper that the researchers also take into account that the high number of deaths may be coincidental.
Every year around 400 people in the Netherlands are diagnosed with cancer of the bile duct, making it a less common form of cancer. Little is known about this type of cancer. Due to the low number of patients, it is difficult to study the cause, risk factors and possible treatments.
The deaths were not reported to the Healthcare and Youth Inspectorate. This is mandatory in the event of a calamity. A spokesperson for the Inspectorate told AD that it is not yet clear whether the hospital should have reported these deaths.