Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT06378853
• Lead Sponsor: Jinling Hospital, China

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-28
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 548

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complications	2019/1/1-2023/12/31	the postoperative complications in PDAC patients
risk factors	2019/1/1-2023/12/31	risk factors of PDAC patients
overall survival	2019/1/1-2023/12/31	overall survival of PDAC patients

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, China