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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06378853
Other study ID # 2023DZKY-049-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date February 28, 2024

Study information

Verified date April 2024
Source Jinling Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

By evaluating the nutritional status of patients with pancreatic ductal adenocarcinoma (PDAC) admitted to Jinling Hospital, collecting relevant clinical data. we aim to conduct correlation analysis with patient clinical information, such as survival time, hospitalization time, nutritional status, hematological indicators, etc., in order to reveal the prognostic factors for overall survival and postoperative complications of PDAC patients.


Description:

Personalized and accurate survival risk prognostication remains a significant challenge in pancreatic ductal adenocarcinoma (PDAC), despite extensive research on prognostic and predictive markers. Patients with PDAC are prone to muscle loss, fat consumption, and malnutrition, which is associated with inferior outcomes. This study investigated the use of three-dimensional (3D) anthropometric parameters derived from computed tomography (CT) scans and hematological indicators in relation to overall survival (OS) outcomes and postoperative complications in PDAC patients. A retrospective analysis was conducted on patients with PDAC, all of whom had undergone pretreatment abdomen-pelvis CT scans. Automatic 3D measurements of subcutaneous and visceral fat volume, skeletal muscle volume, and skeletal muscle density (SMD) were assessed at the L3 vertebral level by an artificial intelligence assisted diagnosis system (HY Medical). Various indicators including TyG-BMI, nutritional indicators [geriatric nutritional risk index (GNRI) and prealbumin], and inflammation indicators [(C-reactive protein (CRP) and neutrophil to lymphocyte ratio (NLR)] were also recorded.


Recruitment information / eligibility

Status Completed
Enrollment 548
Est. completion date February 28, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All eligible patients diagnosed with PDAC Exclusion Criteria: - 1) Suffering from chronic or acute diseases related to malnutrition: chronic heart failure, cirrhosis, chronic kidney disease and infection, cognitive impairment, dysphagia or gastrointestinal obstruction, etc; 2) Using excessive doses of systemic glucocorticoids within 4 weeks prior to enrollment;

Study Design


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
China Jinling Hospital Nanjing

Sponsors (1)

Lead Sponsor Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary complications the postoperative complications in PDAC patients 2019/1/1-2023/12/31
Primary overall survival overall survival of PDAC patients 2019/1/1-2023/12/31
Primary risk factors risk factors of PDAC patients 2019/1/1-2023/12/31
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