Pancreatic SurgeyNCT06585046
Pancreatic Surgery and Risk Factors
An observational study of Pancreatic Surgey and Diabetes Mellitus, run by Shanghai Changzheng Hospital.
Trial 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. What are the clinical characteristics of PCRD? 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Surgey, Diabetes Mellitus
- What is being tested?
- pancreatic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with pancreatic surgery in our centre.
Who may be able to join
- 1. 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.
- -
Who cannot join
- 1. 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.
- -
About this study
Official title: The Risk Factors and Prognosis of Hyperglycemia Secondary to Pancreatic Surgery
The goal of this observational study is to learn about post-pancreatic surgery diabetes mellitus(PCRD).The main questions it aims to answer are:
- What are the clinical characteristics of PCRD?
- What are the related factors for PCRD? All patients with pancreatic surgery have been given standardized treatment fot the condition.
The researchers will summarize the risk factors for PCRD from the PCRD group.
Read the detailed description
Sponsors retrospectively collected data from patients with pancreatic surgery in Changzheng centers between January 2017 and June 2024.
- Conditions
- Pancreatic Surgey, Diabetes Mellitus
- Being tested
- pancreatic surgery
- Keywords
- Pancreatic Surgey, Diabetes Mellitus, PCRD, Risk factor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatic surgeryProcedure or surgery
patients who did pancreas-related surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (within 5 years after surgery)
Secondary outcomes (2)
overall survival
Measured: within 5 years after surgery
Disease-Free Survival
Measured: within 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Jan 2017
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic SurgeyStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuo Li, MD, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585046
- Sponsor's protocol ID
- NMU-3CDM-2A
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk Factors and Prognosis of Hyperglycemia Secondary to Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT06585046
- Acronym / sponsor ID
- NMU-3CDM-2A
- Conditions
- Pancreatic Surgey, Diabetes Mellitus
- Keywords
- Pancreatic Surgey, Diabetes Mellitus, PCRD, Risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about post-pancreatic surgery diabetes mellitus(PCRD).The main questions it aims to answer are:
- What are the clinical characteristics of PCRD?
- What are the related factors for PCRD? All patients with pancreatic surgery have been given standardized treatment fot the condition.
The researchers will summarize the risk factors for PCRD from the PCRD group.
Detailed description
Sponsors retrospectively collected data from patients with pancreatic surgery in Changzheng centers between January 2017 and June 2024.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with pancreatic surgery in our centre.
Key inclusion criteria (2 listed)
- 1. 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.
- -
Key exclusion criteria (2 listed)
- 1. 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreatic surgerypatients who did pancreas-related surgery | Procedure or surgery | – |
Primary outcome
Incidence of glycaemic disorders（prevalence of diabetes） (postoperative fasting blood glucose/HbA1C)
Time frame: (within 5 years after surgery)
The main objective of this study was the incidence of glucose metabolism disorders in patients treated with pancreatic surgery in our centre.
2 secondary outcomes
overall survival
Time frame: within 5 years after surgery
Disease-Free Survival
Time frame: within 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Surgey and Diabetes Mellitus, run by Shanghai Changzheng Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of glycaemic disorders（prevalence of diabetes） (postoperative fasting blood glucose/HbA1C) (time frame: (within 5 years after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.