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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06378853
Recruitment Status : Completed
First Posted : April 23, 2024
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Wang Xinying, Jinling Hospital, China

Tracking Information
First Submitted Date April 18, 2024
First Posted Date April 23, 2024
Last Update Posted Date April 23, 2024
Actual Study Start Date January 1, 2019
Actual Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2024)
  • complications [ Time Frame: 2019/1/1-2023/12/31 ]
    the postoperative complications in PDAC patients
  • overall survival [ Time Frame: 2019/1/1-2023/12/31 ]
    overall survival of PDAC patients
  • risk factors [ Time Frame: 2019/1/1-2023/12/31 ]
    risk factors of PDAC patients
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Tumors of patients are histopathologically confirmed as PDAC
Condition Pancreatic Cancer
Intervention Other: no intervention
no intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 18, 2024)		 548
Original Actual Enrollment Same as current
Actual Study Completion Date February 28, 2024
Actual Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT06378853
Other Study ID Numbers 2023DZKY-049-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Wang Xinying, Jinling Hospital, China
Original Responsible Party Same as current
Current Study Sponsor Jinling Hospital, China
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Jinling Hospital, China
Verification Date April 2024