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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05959213
Other study ID # FPUCampusBioMedico
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2000
Est. completion date March 1, 2023

Study information

Verified date July 2023
Source Fondazione Policlinico Universitario Campus Bio-Medico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In our multicenter retrospective study, preoperative CA 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma .


Description:

A retrospective analysis have been conducted on more than 2.000 patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma radiologically resectable at the preoperative staging. Preoperatory levels of CA 19.9 were measured in order to identify a relation with nodal involvement at the pathological staging.


Recruitment information / eligibility

Status Completed
Enrollment 2034
Est. completion date March 1, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients undergone pancreatoduodenectomy - No preoperative radiological suspicion of lymph node metastases. Exclusion Criteria: - Age < 18

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Campus Bio-Medico

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative data - Preoperatory levels of CA 19.9 (U/ml) Define relation of quantitative data (CA 19.9 (U/ml)) with nodal positivity at the final pathological report 20 years
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