- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03659903
Pancreaticoduodenectomy in Elderly Pancreatic Ductal Adenocarcinoma Patients
Long-term Benefit of Elderly Pancreatic Ductal Adenocarcinoma Patients After Pancreaticoduodenectomy
We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013All the malignant cases were followed-up annually to determine vital status.
The aim of Our study is to make clearly the long-term survival of younger (age <80 years) and elderly (age ≥80 years) pancreatic cancer patients underwent PD. Sec-ond, find out the risk factors of poor prognosis in elderly patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Database We used the SEER database to analyze the data of patients with PDAC. The database includes patients of 18 registries in the USA from 1973-2013, encompassing approxi-mately 28% of the USA population. All the malignant cases were followed-up annu-ally to determine vital status.
Patient Population All the variables' definitions are encoded in the SEER database. To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11 Only cases that underwent PD and microscopically confirmed were included.
Outcome Variables We only included those PDAC patients that underwent PD with precise data available for the following variables: age at diagnosis, year of diagnosis, gender, race, tumor site, tumor size, regional nodes positive, regional nodes examined, grade, stage, vital status, and survival months.
To clearly differentiate the difference of long-term survival between young and elderly patients, all cases were divided into two group age < 80 years and age ≥ 80 years. Since 2004, the AJCC 6th stage has been used in the SEER database. Thus, the diagnosis years of the cases included in our study ranged from 2004-2013. To analyze the median OS between different time periods, we divided the year of diagnosis into two groups: 2004-2008 year and 2009-2013. Furthermore, we also divided the tumor size into three groups: ≤ 2 cm, 2-4 cm, and > 4 cm. The lymph node ratio (LNR) is considered a robust prognostic factor after resection of pancreatic cancer and was es-timated using regional nodes positive divided by regional nodes examined.15 LNR was then categorized into three groups: 0%, 1-50%, > 50%.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with pancreatic ductal adenocarcinoma,treatment by pancreaticoduodenectomy.Only cases that underwent PD and microscopically confirmed were included.
Exclusion Criteria:
- Patients with no survival data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
younger patients (age < 80)
age < 80 patients, All the variables' definitions are encoded in the SEER database.
To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9)
and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11
Only cases that underwent PD and microscopically confirmed were included.
|
pancreaticoduodenectomy
|
older patients (age≥ 80 )
age ≥ 80 years-old patients,All the variables' definitions are encoded in the SEER database.
To identify the PDAC cases, site codes (C25 pancreas, C25.0-C25.9)
and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) were used.11
Only cases that underwent PD and microscopically confirmed were included.
|
pancreaticoduodenectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
median OS
Time Frame: to 2013 Dec. 31
|
The median overall survival of all patients
|
to 2013 Dec. 31
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YJ-KY-FB-2017-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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