NCT06585046

Brief Summary

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

  1. 1.What are the clinical characteristics of PCRD?
  2. 2.What are the related factors for PCRD? All patients with pancreatic surgery have been given standardized treatment fot the condition.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7.6 years

First QC Date

September 2, 2024

Last Update Submit

September 5, 2024

Conditions

Keywords

Pancreatic SurgeyDiabetes MellitusPCRDRisk factor

Outcome Measures

Primary Outcomes (1)

  • Incidence of glycaemic disorders(prevalence of diabetes) (postoperative fasting blood glucose/HbA1C)

    The main objective of this study was the incidence of glucose metabolism disorders in patients treated with pancreatic surgery in our centre.

    (within 5 years after surgery)

Secondary Outcomes (2)

  • overall survival

    within 5 years after surgery

  • Disease-Free Survival

    within 5 years after surgery

Interventions

patients who did pancreas-related surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients treated with pancreatic surgery in our centre.

You may qualify if:

  • \. Age ≥18 years and \<80 years, male or female; 2. Patients who underwent pancreatic resection in pancreaticobiliary surgery since January 2017 3. Those who have previously completed a cohort study in pancreaticobiliary surgery and signed informed consent; 4. Those who have completed and banked serum specimens and pathology specimens in our hospital.

You may not qualify if:

  • \. Age \<18 years or ≥80 years; 2. Those with preoperative fasting blood glucose ≥5.8 mmol/l or HbA1c ≥6.0% or a history of diabetes; 3. Those with missing relevant data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shanghai Changzheng Hospital

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 5, 2024

Study Start

January 1, 2017

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share