Diabetes risk after pancreatic cancer surgery
Prospective Cohort Study on Endo-Exdo Secretory Function Alterations and All-round Outcomes After Pancreatic Cancer
This tests how often adults without prior diabetes develop pre-diabetes or diabetes after pancreatic cancer surgery and whether changes in pancreatic hormone and enzyme function affect recovery and overall outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06585072 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of adults undergoing pancreatectomy at Shanghai Changzheng Hospital, with standardized perioperative care and banked serum and pathology samples. Enrolled participants who do not have pre-existing diabetes undergo continuous peripheral blood glucose monitoring to capture incident pre-diabetes and diabetes. The study will compare rates of new glucose metabolic disorders across different pancreatic disease etiologies and surgical procedures. It will also examine whether changes in endocrine and exocrine pancreatic function after surgery are linked to overall clinical outcomes.
Who should consider this trial
Good fit: Adults (≥18) with pancreatic cancer scheduled for pancreatectomy at Shanghai Changzheng Hospital who do not have prior diabetes and who can provide informed consent are ideal candidates.
Not a fit: Patients with pre-existing diabetes or pre-diabetes, positive islet autoantibodies, secondary diabetes risk factors, pregnant or nursing women, or those unable to consent are excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could identify patients at higher risk of developing new-onset glucose disorders after pancreatic surgery and inform targeted monitoring and early treatment to reduce complications.
How similar studies have performed: Previous observational work has documented new-onset diabetes after pancreatic resection and suggested links between endocrine/exocrine changes and outcomes, but results vary and prospective, standardized data collection like this remains relatively common rather than novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. male or female Chinese subjects; 2. Age ≥ 18 years; 3. patients with pancreatic cancer who are proposed to undergo pancreatectomy by pancreaticobiliary surgery at our hospital; 4. those who voluntarily completed the Pancreatobiliary Surgery Cohort Study and signed the informed consent; 5. those who have completed and banked serum and pathological specimens at our hospital. \- Exclusion Criteria: 1\. those with a previous history of comorbid diabetes mellitus or pre-diabetes mellitus, or preoperative HbA1C ≥ 6.0% or fasting blood glucose ≥ 6.1 mmol/l; 2. those with positive islet-associated antibodies 3. those with the presence of medications, endocrine disease exposures that can lead to a risk of secondary diabetes; 4. pregnant or nursing women; 5. Cognitive impairment or other reasons for failing to sign the informed consent form. \-
Where this trial is running
Shanghai, Shanghai Municipality
- Changzheng Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Tuo Li, Doctor
- Email: dr.lituo@smmu.edu.cn
- Phone: 86-13918507887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.