Clinical trial · Observational
Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus
Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus: A Monocentric Ambispective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus Type 2 | — | UNRESOLVED | — |
| Pancreatectomy | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Prospective Cohort
- description
- Prospectively enrolled adult patients with diabetes at baseline undergoing partial, near-total, or total pancreatectomy at the study center.
- label
- Ambispective Cohort
- description
- Patients with diabetes at baseline with retrospective baseline data and prospective postoperative follow-up after pancreatic surgery.
- label
- Retrospective Cohort
- description
- Retrospective cohort of adult patients with diabetes at baseline who underwent pancreatic surgery at the study center.
Primary outcomes (1)
- measure
- Worsening of Glycemic Control After Pancreatectomy
- timeFrame
- Within 12 months after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Written informed consent for the ambispective and prospective components, where applicable Exclusion Criteria: * 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 * Refusal, withdrawal, or inability to provide informed consent for the ambispective and prospective components, where applicable
References
Publications (0)
Data not yet available