About this trial
This study investigates the impact of GLP-1 receptor agonists (GLP-1 RAs) on patients with intraductal papillary mucinous neoplasms (IPMNs), a type of pancreatic cystic neoplasm that can progress to malignancy. With the increasing use of GLP-1 RAs for managing diabetes and obesity, concerns about their potential to influence pancreatic conditions, like IPMNs, have emerged. Although GLP-1 RAs are generally safe, their effects on pre-existing pancreatic conditions remain unclear.
The study aims to evaluate whether GLP-1 RA use in IPMN patients is linked to changes in pancreatic cyst characteristics, the incidence of acute pancreatitis, variations in tumor markers, and the progression of IPMNs to high-grade dysplasia or malignancy. A retrospective analysis will be conducted using medical data from patients diagnosed with IPMNs and treated with GLP-1 RAs between 2010 and 2024 at three Swiss hospitals. Key outcomes will include radiological changes, the incidence of acute pancreatitis, and potential shifts in IPMN surveillance or need for surgical intervention
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
> 18 years old
Radiological diagnosis of IPMN
Treated with GLP-1 RAs.
Patients must have provided prior informed consent for the use of their coded clinical data in research.
Disqualifiers
radiological diagnosis of IPMN is unclear,
no documented history of GLP-1 RAs use
patients did not provide signed informed consent, or have documented refusal for research.
Trial population
The study population consists of adult patients diagnosed with intraductal papillary mucinous neoplasms (IPMNs) who have been treated with GLP-1 receptor agonists (GLP-1 RAs) for diabetes or obesity management
Trial design
Cohort
Retrospective
Treatments tested in this trial
GLP1 receptor agonist
DrugPatients must be under GLP1-RA treatment for ether diabetes or obesity
Treatment groups
Trial outcomes
Primary outcomes
Radiological changes in pancreatic cyst characteristic as described in the Kyoto 2023 Consensus
Radiological data, including data from MRI scans, will be used to monitor changes in IPMN characteristics. If only CT scans are available, they will also be evaluated, even if this is not the preferred imaging method for IPMN evaluation
Secondary outcomes
Incidence of acute pancreatitis
The incidence of acute pancreatitis under GLP1-RA will be evaluated
Changes in serum tumor markers, CA19-9 and CEA levels
When already available in routine analyses before and after initiation of GLP-1 RA therapy, tumor markers level will be assessed to detect any changes
Changes in Endoscopic ultrasonography (EUS) characteristics
Evaluate the changes of morphological IPMN characteristic in endoscopic ultrasonography (EUS)
Progression of IPMNs to high-grade dysplasia or invasive malignancy in histopathological analysis
Evaluate the progression of IPMNs to high-grade dysplasia or invasive malignancy in histopathological analysis
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hôpital Fribourgeois
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
University Hospital, Geneva
Collaborator
This trial is not recruiting at the moment. You can still explore other options: