Clinical trial NCT06344299: Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma
Official title: Department of Hepato-Biliary-Pancreatic Surgery, Huadong Hospital Affliated to Fudan University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: pancreatic ductal adenocarcinoma
elderly
treatment abandonment
relative weight analysis
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 5302
Sex: ALL
Minimum age (years): 75
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Detailed description: The incidence of pancreatic ductal adenocarcinoma (PDAC) in the elderly has been on the rise, but the elderly were always neglected in clinical oncology care. Pancreatic ductal adenocarcinoma is a lethal disease, and the most effective treatment for curing it remains the radical resection. Unfortunately, there are many a study had reported that the rate of radical surgery of patients with PDAC has been low in the past decade. In order for more elderly pancreatic cancer patients to undergo surgical resection, investigators extracted the data of elderly patients with PDAC from SEER program and investigated predictive factors associated with surgical resection abandonment. In this study, investigators extracted data of patients older than 75 years diagnosed with T1-T3 stage PDAC to investigate rate of radical surgery. And researchers used Univariate and multivariate logistic regression model to explore potential factors associated with patients and surgeon chose to abandon surgical resection.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: ORs of potential predictors
timeFrame: months from diagnosis to surgical resection, up to 12 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: up to 132 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huadong Hospital affiliated to Fudan University
Study officials:
References: