Clinical trial NCT06378853: Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients
Official title: Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients Based on Body Compositions Measured by 3D CT Scan and Hematological Indicators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
risk factors
postoperative complications
overall survival
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tumors of patients are histopathologically confirmed as PDAC

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.

Eligibility criteria: 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;

Primary outcomes:
measure: complications
timeFrame: 2019/1/1-2023/12/31
measure: overall survival
timeFrame: 2019/1/1-2023/12/31
measure: risk factors
timeFrame: 2019/1/1-2023/12/31
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
Study officials:
References: