Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss After Pancreatectomy in Non-Diabetic Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

This study will examine how removal of part or all of the pancreas affects blood sugar control, metabolism, and clinical outcomes over time.

The study will include adults without diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS.

Researchers will study whether participants develop diabetes after surgery and whether this risk changes according to the type of pancreatic resection.

Information from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years)

No diabetes mellitus at baseline

Undergoing partial, near-total, or total pancreatectomy at the study center

Availability of clinical and metabolic data according to study component

Disqualifiers

Diabetes mellitus at baseline

Age <18 years

Missing key clinical data precluding eligibility assessment or primary outcome evaluation

Refusal or inability to provide informed consent for the prospective component, where applicable

Trial population

Adult patients without diabetes at baseline undergoing partial, near-total, or total pancreatectomy according to routine clinical practice for benign or malignant pancreatic diseases at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, including retrospective, ambispective, and prospective study components.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

579 Participants
are grouped into 3 trial groups
Group A: Prospective Cohort
Group B: Retrospective Cohort
Group C: Ambispective Cohort

Trial outcomes

Primary outcomes

1

Incidence of New-Onset Diabetes Mellitus After Pancreatectomy

Incidence of new-onset diabetes mellitus in participants without diabetes at baseline according to the type of pancreatic resection.

Time frame
Within 12 months after surgery

Secondary outcomes

1

To assess the deterioration of glucose metabolism during post-pancreatectomy follow-up

To assess the deterioration of glucose metabolism during post-pancreatectomy follow-up, defined as worsening of glycemic control parameters and/or the initiation or intensification of glucose-lowering therapy in patients without diabetes mellitus at baseline

Time frame
From enrollment to the end of treatment at 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

European Foundation for the Study of Diabetes

Collaborator