Diagnostic Prediction of Pancreatic Masses

NCT06724055 | Completed

• 1 other identifier: 2024-DPPM
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn if a strategy can be developed for differentiating autoimmune pancreatitis (AIP) and primary pancreatic lymphoma (PPL) from pancreatic ductal adenocarcinoma (PDAC) in patients presenting with pancreatic masses. The main question it aims to answer is: What features, in the perspectives of clinical manifestation, laboratory tests, and imaging, can differentiate different kinds of pancreatic masses (AIP, PPL and PDAC)? Participants will not be given any interventions since this is a retrospective observational study.

Conditions

Pancreatic Masses

Outcome Measures

Primary Outcomes (1)

• Diagnostic nomogram

  From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

Secondary Outcomes (4)

• serum level of LDH

  From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

• serum level of IgG4

  From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

• largest diameter of pancreatic masses

  From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

• dilation of pancreatic duct

  From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

Study Arms (3)

AIP

PPL

PDAC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients in Peking Union Medical College Hospital.

You may qualify if:

• Inpatients presenting with pancreatic masses and eventually diagnosed with PPL, AIP, or PDAC (confirmed by pathologic results).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2002
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share