Risk Factors of Postoperative Complications and Survival... | NCT06378853

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

NCT06378853

Sponsor

Jinling Hospital, China

Status

Completed

Last Update Posted

Apr 23, 2024Actual

Enrollment

548Actual

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

no intervention

Countries

China

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

Apr 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, 2019Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

Apr 18, 2024

First Submission Date that Met QC Criteria

Apr 18, 2024

First Posted Date

Apr 23, 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

Apr 18, 2024

Last Update Posted Date

Apr 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

No data available

No data is available for this block.

Enrollment

548Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complications	the postoperative complications in PDAC patients	2019/1/1-2023/12/31
overall survival	overall survival of PDAC patients	2019/1/1-2023/12/31
risk factors	risk factors of PDAC patients	2019/1/1-2023/12/31

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Tumors of patients are histopathologically confirmed as PDAC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinling Hospital		Nanjing			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42087590	Derived	Wang J, Maitiabula G, Liu S, Li R, Wang S, Zhou P, Xia Y, Huang L, Chen X, Gao X, Zhang L, Wang X. The Eubacterium Rectale Derived Extracellular Vesicles Alleviate Cancer Cachexia Induced Lipolysis by Inhibiting Macrophage Polarization. J Extracell Vesicles. 2026 May;15(5):e70293. doi: 10.1002/jev2.70293.

ID	Term
D010190	Pancreatic Neoplasms
D011183	Postoperative Complications

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms