Diagnostic Prediction of Pancreatic Masses

December 6, 2024 updated by: Peking Union Medical College Hospital

Diagnostic Prediction of Pancreatic Masses: How to Avoid an Unnecessary Resection

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

110

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inpatients in Peking Union Medical College Hospital.

Description

Inclusion Criteria:

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

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
AIP
PPL
PDAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic nomogram
Time Frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Time Frame
serum level of LDH
Time Frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
serum level of IgG4
Time Frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
largest diameter of pancreatic masses
Time Frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
dilation of pancreatic duct
Time Frame: From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months
From date of admission into the hospital to the establishment of diagnosis, assessed up to 100 months

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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, 2002

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-DPPM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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