Pancreatic Cancer and Diabetes Mellitus

Not yet recruiting

• Conditions: Pancreatic Cancer; Surgery; Diabetes Mellitus

• Registration Number: NCT06585072
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are:

1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?

2. Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition.

The reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.

Detailed Description

Investigators will prospectively collect data from patients with pancreatic cancer after surgery in participant centers.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-02
• Study First Posted: 2024-09-05
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Study Start: 2025-03-03
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus)	From enrollment to five years after the end of the surgery	The diagnosis of glucose disorders should be made applying criteria of the American Diabetes Association.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From enrollment to five years after the end of the surgery
Disease-Free Survival	From enrollment to five years after the end of the surgery