Impact of GLP-1 Receptor Agonists on Patients With IPMN

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital Fribourgeois

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 volunteers

Qualifiers

> 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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • GLP1 receptor agonist

    Drug

    Patients must be under GLP1-RA treatment for ether diabetes or obesity

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intraductal Papillary Mucinous Neoplasms1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
during the GLP1 RA treatment

Secondary outcomes

1

Incidence of acute pancreatitis

The incidence of acute pancreatitis under GLP1-RA will be evaluated

Time frame
during the GLP1 RA treatment
2

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

Time frame
during the GLP1 RA treatment
3

Changes in Endoscopic ultrasonography (EUS) characteristics

Evaluate the changes of morphological IPMN characteristic in endoscopic ultrasonography (EUS)

Time frame
during the GLP1 RA treatment
4

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

Time frame
during the GLP1 RA treatment

Other outcomes

Sponsors and contacts

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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: