Digestive Centre

Digestive Centre

Clinical studies

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Patients who wish to do so can participate in a clinical study. Here is a list of the current studies:

Digestive oncology (more information available from Dr E Monsaert and Dr E. Vanderstraeten)

  • TRIPP-FFX (Oncosil): An open-label, multicentre, randomised trial on targeted intratumor placement of phosphorus-32 (OncoSil™) as a supplement to FOLFIRINOX chemotherapy versus only using FOLFIRINOX chemotherapy in patients who have inoperative, locally-advanced adenocarcinoma of the pancreas.
  • ASPIRIN (UZA): A phase-III, double-blinded, placebo-controlled, randomised clinical trial to assess the effect of low-dose aspirin on relapse and survival in colorectal cancer patients.
  • SORENTO / HS-19-657 (Camurus): A randomised, multi-centre, open-label, actively controlled phase-3 study to evaluate the safety and effectiveness of the octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients with neuro-endocrine gastroenteropancreatic tumours.
  • NALPAC (BGDO): A non-comparative randomised phase-II study evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX in patients with metastatic ductal pancreatic adenoma carcinoma progressive after gemcitabine-abraxana or gemcitabine monotherapy.
  • PREFER (Amsterdam University): Study on the safety of endoscopic follow-up of early oesophageal cancer.
  • Folicolor trial (UZA): Follow-up of treatment response using blood samples in metastatic colorectal cancer patients.
  • PAPHYRA (UZB Erasmus Hospital): Evaluation of the physician-patient relationship after consultation for the implementation of a new systematic treatment for advanced hepatocellular carcinoma: need for information, knowledge of the prognosis and expectations for the treatment in terms of efficacy and side effects.

Crohn's Disease and/or Colitis Ulcerosa (more information available from Dr D. Baert, Dr N. Deprez and Prof Dr P. Dewint)

  • Rescue (BIRD non-profit organisation): Loss of response to Ustekinumab treated with dose escalation.
  • 1425-0003 (Boehringer Ingelheim): A randomised, double-blind, placebo-controlled phase-IIa study to evaluate the safety, efficacy, pharmacokinetics and pharmodynamics of BI 706321 as orally administered for twelve weeks in patients with Crohn's disease who are receiving induction treatment with ustekinumab.
  • MH002-UC-201 (MRM Health): An exploratory study to assess the safety, mechanistic and clinical effects of MH002 in participants who have acute pouchitis.
  • CULTIVATE (Arena): A randomised, double-blind, placebo-controlled, multi-centre phase III study to assess whether Etrolizumab is a safe and efficacious treatment for participants with moderately to severely active Crohn's Disease.
  • AIM-CD / M20-371 (Abbvie): A randomised, double-blind, placebo-controlled phase II study on the safety and efficacy of ABBV-154 in test subjects with moderate-to-severe Crohn's disease.
  • SOPRANO CD (Leuven University Hospital) Prevention of post-operative endoscopic illness relapse with Crohn's Disease: a multi-centre study comparing the systematic initiation of biological therapy immediately after a surgical resection with the more targeted initiation of biological therapy in patients with endoscopic lesions six months after the procedure.

Endoscopic treatments (more information available from Prof Dr P. Dewint and Dr S. Van Langendonck)

  • BOTOMY study (UZA): Endoscopic treatment in therapy refractory gastroparesis.
  • PURASTAT duodenum (Leuven University Hospital): Study to evaluate the effectiveness of PuraStat® in the prevention of delayed bleeding after EMR of non-ampulary duodenal lesions.
  • ENDONASH (ULB) Multicentre study to evaluate an endoluminal suture system (Endomina®) as support for treatment of non-alcoholic steatohepatitis.

Celiac disease (more info at Dr D Baert)

  • TAK-062-2001 (Takeda): A randomised, double-blind, placebo-controlled phase-II dose range study evaluating the efficacy and safety of TAK-062 for the treatment of active celiac disease in subjects attempting to follow a gluten-free diet.

Scientific research is indispensable for the advancement of science. By participating in clinical studies, we are able to expand current treatment options and provided patients with access to the very latest treatments.


Non-alcoholic steatohepatitis (NASH) (more information with Prof Dr C. Van Steenkiste and Dr T. De Somer)

  • ESSENCE/NN9931-4553 (Novo Nordisk): The effect of semaglutide on test subjects with non-cirrhotic, non-alcoholic steatohepatitis.
  • NATiV3 / 337HNAS20011 (Inventiva Pharma): A randomised, double-blind, placebo-controlled, phase-3 study in multiple centres to evaluate the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic, non-alcoholic steatohepatitis (NASH) and liver fibrosis in fibrosis stage 2 (F2)/fibrosis stage 3 (F3).
  • LEGEND (Inventiva Pharma): A placebo-controlled, proof-of-concept study to evaluate the safety and effectiveness of Lanifibranor as a stand-alone remedy and in combination with the natrium-glucose transport-protein-2 (SGLT2)-inhibitor Empagliflozine in test subjects who have non-alcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM)

Alcoholic hepatitis (more information with Prof Dr C. Van Steenkiste and Dr T. De Somer)

  • Cortisave: Evaluation of the efficacy of corticosteroids in the treatment of alcoholic hepatitis in spontaneous improvement.

Clostridium difficile infection (more information from Prof Dr C. Van Steenkiste and Dr T. De Somer)

Non-Helicobacter pylori helicobacters (NHPH) (more info from Prof. Dr. C Van Steenkiste)

  • Evaluation of the prevalence and role of non-Helicobacter pylori helicobacters (NHPH) in defined risk populations.

Participation in these studies is on a voluntary basis and written consent is required. You are free to stop with them whenever you want, without this affecting further treatment and the relationship with your physician.