Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma

NCT06344299 | Completed DMC

• 1 other identifier: HuaDong Hosiptal of FUDAN
• Study Type: observational
• Target: 5,302
• Locations: 1 country
• Sites: 1

Brief Summary

More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. It's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

pancreatic ductal adenocarcinoma; elderly; treatment abandonment; relative weight analysis

Outcome Measures

Primary Outcomes (1)

• ORs of potential predictors

  Univariate and multivariate logistic regression model were used to calculate ORs

  months from diagnosis to surgical resection, up to 12 months

Secondary Outcomes (1)

• Overall survival (OS)

  up to 132 months

Study Arms (2)

group of undergoing radical surgery

Elderly patients diagnosed with resectable PDAC underwent radical surgery.

group of abandoning radical surgery

Elderly patients diagnosed with resectable PDAC abandoned radical surgery, the reasons of treatment abandonment included surgeons didn't recommend surgery for their elderly patients and patients chose to refuse surgery.

Other: potential predictors

Interventions

potential predictors OTHER

Researchers want to investigate some important factors that influence elderly patients not to undergo radical surgery.

group of abandoning radical surgery

Eligibility Criteria

• Age: 75 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Researchers included all elderly patients with T1-T3 stage PDAC recorded in SEER program, which would be candidates for undergoing radical surgery. Patients with metastatic disease were excluded. In addition, Investigators want to demonstrate survival benefit of radical surgery for elderly patients, so patients without complete survival time were excluded.

You may qualify if:

• patients older than 75 years old and were diagnosed with pancreatic ductal adenocarcinoma by positive histology.
• Patients were diagnosed with T1 through T3, M0 tumor based on criteria of TNM stage.

You may not qualify if:

• Patients were diagnosed by death certificate.
• Patients died before radical surgery.
• Patients with important data missing, such as T-stage, surgical resection status, surgery procedures and complete survival time.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong Hospital affiliated to Fudan University

Shanghai, 200040, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of hospital

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 3, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

CN (1)