AMC was deficient in the investigation on galwegkanker

The safety of patients with biliary cancer may have been compromised by a study conducted by the Academic Medical Center (AMC) in Amsterdam in the fatal disease. This is the conclusion of the Central Committee for Human Research (CCMO) in a report.

During the study, which began in 2013, a surprisingly large difference occurred in the mortality rates of two groups of patients. The hospital therefore decided to terminate the investigation in 2016. The patients were only informed about this after the newspaper AD denounced this in March 2018.

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Drainage [19659005] The study examined two common methods of biliary drainage. In one group, this happened through a tube through the mouth, with the other with a tube through the skin. In the first group, three patients died, in the second group eleven.

This number surprised the researchers. Although it is clear that no error has been made in the research itself, the study has been discontinued. Neither the patients nor the CCMO were informed, although this should have been done. The hospital told parents and patients not to come in because it reminded them of a difficult time. There was also no clear explanation for the different mortality rates.

According to the supervisor, studies completed prematurely must be reported within seven days. The university hospital must also ensure that patients are properly informed in this case. The AMC tells AD to take the recommendations "to heart".

Last week, the UMC of Amsterdam, the recently completed merger of the AMC and VUMC, was still in the news when it became clear hospital immediately stopped a study in pregnant women. Many newborns have died using the sildenafil product.