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

March 27, 2024 updated by: Zhijun Bao, Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

5302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200040
        • Huadong Hospital Affiliated to Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Researchers want to investigate some important factors that influence elderly patients not to undergo radical surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORs of potential predictors
Time Frame: months from diagnosis to surgical resection, up to 12 months
Univariate and multivariate logistic regression model were used to calculate ORs
months from diagnosis to surgical resection, up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 132 months
The date of definite diagnosis to death or last follow up
up to 132 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HuaDong Hosiptal of FUDAN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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