Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas.

Completed

• Conditions: Pancreas Cancer

• Registration Number: NCT05959213
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

Brief 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 .

Detailed 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.

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2023-03-01
• Study First Submitted: 2023-05-23
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-15
• Last Update Submitted: 2023-07-15
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2034

Inclusion Criteria

• All patients undergone pancreatoduodenectomy
• No preoperative radiological suspicion of lymph node metastases.

Exclusion Criteria

• Age < 18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative data - Preoperatory levels of CA 19.9 (U/ml)	20 years	Define relation of quantitative data (CA 19.9 (U/ml)) with nodal positivity at the final pathological report