Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus

Trial statusNot yet recruiting
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 with diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS.

Researchers will study whether glycemic control worsens after surgery and whether this risk changes according to the type of pancreatic resection. The study will also examine changes in glucose metabolism, and cancer-related outcomes.

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)

Diabetes mellitus at baseline

Undergoing partial, near-total, or total pancreatectomy at the study center for benign or malignant pancreatic disease

Availability of clinical and metabolic follow-up data according to study component

Disqualifiers

Age <18 years

Absence of diabetes mellitus at baseline

Missing essential clinical data or incomplete follow-up precluding evaluation of study outcomes

Severe pre-existing non-oncologic clinical conditions with life expectancy <6 months

Trial population

Adult patients with diabetes mellitus 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

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

Trial outcomes

Primary outcomes

1

Worsening of Glycemic Control After Pancreatectomy

Worsening of glycemic control in participants with diabetes at baseline, defined as HbA1c ≥7.0% within 12 months after surgery according to the type of pancreatic resection.

Time frame
Within 12 months after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

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

This trial is not recruiting at the moment. You can still explore other options: