Pancreatic Surgery and Risk Factors | NCT06585046

Studies
Pancreatic Surgery and Risk Factors

NCT06585046

Sponsor

Shanghai Changzheng Hospital

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

382Actual

Phase

Not provided

Conditions

Pancreatic Surgey
Diabetes Mellitus

Interventions

pancreatic surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Aug 1, 2024Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Sep 2, 2024

First Submission Date that Met QC Criteria

Sep 2, 2024

First Posted Date

Sep 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tuo Li, MD, Shanghai Changzheng Hospital, Shanghai Changzheng HospitalPrincipal Investigator

Lead Sponsor

Shanghai Changzheng HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

382Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pancreatic surgery	Procedure	patients who did pancreas-related surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
overall survival		within 5 years after surgery
Disease-Free Survival		within 5 years after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients treated with pancreatic surgery in our centre.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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