Impact of GLP-1 Receptor Agonists on Patients With IPMN

NCT07014709 | Not Yet Recruiting

• 1 other identifier: IPMN-GLP1RA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IPMN; IPMN, Pancreatic; GLP-1; Intraductal Papillary Mucinous Neoplasm of Pancreas; Glucagon-Like Peptide-1 Receptor Agonists

Outcome Measures

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

  during the GLP1 RA treatment

Secondary Outcomes (6)

• Incidence of acute pancreatitis

  during the GLP1 RA treatment

• Changes in serum tumor markers, CA19-9 and CEA levels

  during the GLP1 RA treatment

• Changes in Endoscopic ultrasonography (EUS) characteristics

  during the GLP1 RA treatment

• Progression of IPMNs to high-grade dysplasia or invasive malignancy in histopathological analysis

  during the GLP1 RA treatment

• Need for surgical intervention

  during the GLP1 RA treatment

Study Arms (1)

Intraductal Papillary Mucinous Neoplasms

Patients eligible for this study must have a radiological diagnosis of IPMN

Drug: GLP1 receptor agonist

Interventions

GLP1 receptor agonist DRUG

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

Intraductal Papillary Mucinous Neoplasms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital Fribourgeois: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

HFR Hopital fribourgeois

Villars-sur-Glâne, 1752, Switzerland

Location

Related Publications (1)

• Ohtsuka T, Fernandez-Del Castillo C, Furukawa T, Hijioka S, Jang JY, Lennon AM, Miyasaka Y, Ohno E, Salvia R, Wolfgang CL, Wood LD. International evidence-based Kyoto guidelines for the management of intraductal papillary mucinous neoplasm of the pancreas. Pancreatology. 2024 Mar;24(2):255-270. doi: 10.1016/j.pan.2023.12.009. Epub 2023 Dec 28.

  PMID: 38182527 BACKGROUND

MeSH Terms

Conditions

Pancreatic Intraductal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Melissa Lagger, Dipl.med

CONTACT

+41798164051; melissa.lagger@h-fr.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 11, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

CH (1)