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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Department of Hepato-Biliary-Pancreatic Surgery, Huadong Hospital Affliated to Fudan University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06344299
• Other study ID #: HuaDong Hosiptal of FUDAN
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5302
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Other:
• potential predictors
Researchers want to investigate some important factors that influence elderly patients not to undergo radical surgery.

Locations

Country	Name	City	State
China	Huadong Hospital affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	The date of definite diagnosis to death or last follow up	up to 132 months