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ISABIAL launches an international clinical trial on the treatment of acute pancreatitis involving more than 160 centers in 44 countries

ISABIAL launches an international clinical trial on the treatment of acute pancreatitis involving more than 160 centers in 44 countries

The WATERLAND study, funded by the Carlos III Health Institute (ISCIII) through the Strategic Action in Health, will compare two types of fluids to treat the disease

The research is led by Dr. Enrique de Madaria, gastroenterologist at the Alicante Health Department – General Hospital

Alicante (30.04.23). The Alicante Institute for Health and Biomedical Research (ISABIAL) has launched an international clinical trial comparing two types of fluids for the treatment of acute pancreatitis. The study, called WATERLAND, will involve 160 centers in 44 countries and is funded by the Carlos III Health Institute (ISCIII), an agency of the Ministry of Science and the Ministry of Health, through the Strategic Action in Health.

The project of ISABIAL’s Clinical Research Group in Pancreatology is led by Dr. Enrique de Madaria, Deputy Scientific Director for Projects at ISABIAL, gastroenterologist at Dr. Balmis Alicante General University Hospital, and President of the Spanish Association of Gastroenterology. Dr. de Madaria explains that “this clinical trial, designed and coordinated by our Alicante‑based group, is the most ambitious trial in pancreatitis that we have carried out. In addition, it is the clinical trial promoted from Alicante involving the largest number of international centers”.

To carry out the clinical trial, the group led by Dr. Enrique de Madaria has promoted the creation of an international research consortium called ERICA, which, as he explains, “is an international network of centers united to advance the management of patients with biliary and pancreatic diseases.” This study represents a further step in the trajectory of the ISABIAL group following the success of the international multicenter WATERFALL study, published in 2022 in the prestigious New England Journal of Medicine, and considered one of the 10 best gastroenterology articles published worldwide that year by the international medical news agency Medscape.

The WATERFALL study showed that administering an intensive intravenous fluid regimen—which was the treatment recommended up to that point—was associated with adverse effects without providing benefits. As a result, the clinical trial led by the Alicante Institute for Health and Biomedical Research changed clinical practice in the treatment of acute pancreatitis.

Researcher Enrique de Madaria explains that “acute pancreatitis is a sudden inflammation of the pancreas that produces intense pain, and an important part of its treatment is the administration of intravenous fluids, known as ‘drips’.” In the WATERLAND study, notes the Deputy Scientific Director for Projects at ISABIAL, “we are comparing two types of fluids, Ringer’s solution versus saline.” Enrique de Madaria concludes that “we believe that Ringer’s solution may have anti‑inflammatory properties that improve the course of this disease”.

The ISABIAL team that will work on the clinical trial also includes the clinical trial and pharmaceutical coordination team, Alicia Vaíllo; the clinical pharmacologist, Pedro Zapater; and the collaborating researcher, Lucía Guilabert.

Harvard

In addition, Dr. Enrique de Madaria will co‑direct in January 2024 the course Management of Pancreatic Disorders for the Practicing Clinician at Harvard University (Harvard Medical School), together with Yasmin Hernández Barco, gastroenterologist at Massachusetts General Hospital in Boston. The ISABIAL Clinical Research Group in Pancreatology is considered an international benchmark in biliary and pancreatic diseases, both in clinical gastroenterology and in advanced endoscopy and surgery.

Author: José Antonio Más Cayuelas

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