Prostaglandin-E Urinary Metabolite (PGE-M) as a Predictor of Acute Appendicitis in Children

May 29, 2025 updated by: Tomislav Žuvela, KBC Split

Diagnosing acute appendicitis in children remains a clinical challenge, with delayed or incorrect diagnosis potentially leading to serious complications or unnecessary surgery. Prostaglandin E urinary metabolites (PGE-M) have been found elevated in various inflammatory conditions, but their diagnostic value in pediatric appendicitis is not well established. This study aims to assess the potential of PGE-M as a biomarker for acute appendicitis in children.

The study will be conducted over 12 months and will include 100 children aged 5 to 17 years presenting with acute abdominal pain. In addition to routine laboratory tests, urinary PGE-M levels will be analyzed. The study involves minimal risk to participants

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The diagnosis of acute appendicitis in children remains a challenge, even for experienced clinicians. Failure to recognize this acute condition may result in perforation and subsequent peritonitis, whereas misdiagnosis can lead to unnecessary (negative) appendectomies. Elevated levels of prostaglandin E urinary metabolites (PGE-M) have been observed in other inflammatory conditions such as inflammatory bowel disease, acute mesenteric ischemia, and necrotizing enterocolitis.

The aim of this study is to determine whether PGE-M levels are elevated in children with acute appendicitis and whether this biomarker could be used in the diagnosis of acute appendicitis.

The planned duration of the study is 12 months, with a projected sample size of 100 participants.

Inclusion criteria: Children aged 5 to 17 years presenting with acute abdominal pain and signs and symptoms suggestive of acute appendicitis, without significant comorbidities.

Exclusion criteria: Children outside the specified age range, those with a previously diagnosed chronic or malignant disease, a history of abdominal surgery, or pregnancy.

For each child included in the study, demographic data, clinical characteristics, laboratory and diagnostic test results, intraoperative findings, and discharge diagnoses will be recorded. Since the child is already indicated for surgery or hospital admission regardless of study participation, there are no significant risks associated with participation in this study-apart from potential, but rare, complications related to peripheral venous blood sampling (e.g., hematoma or discomfort).

For the purposes of the study, a peripheral venous blood sample will be collected (on the day of surgery or hospital admission) to analyze laboratory parameters including leukocyte count, C-reactive protein, and neutrophils. Additionally, a urine sample will be collected to determine the levels of prostaglandin E urinary metabolites (PGE-M) and creatinine

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients from 5 to 17 years of age, presenting with acute abdominal pain consistent with diagnosis of acute appendicitis, to Emergency Surgical Department at the University Hospital of Split

Description

Inclusion Criteria:

  • children of age 5 -17 years with acute abdominal pain
  • children with clinical signs of acute appendicitis

Exclusion Criteria:

  • previous diagnosis of chronic and/or malignant disease
  • children who had previous abdominal surgery
  • pregnancy

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
Intervention / Treatment
Acute appendicitis with rupture
Diagnostic test: Blood specimen collection
Blood specimen collection for analysis of C-reactive protein, white blood cell count and neutrophile count.
Diagnostic test: Urine collection
Urine sample collection for analysis of creatinine and prostaglandin E urinary metabolites
Acute appendicitis without rupture
Diagnostic test: Blood specimen collection
Blood specimen collection for analysis of C-reactive protein, white blood cell count and neutrophile count.
Diagnostic test: Urine collection
Urine sample collection for analysis of creatinine and prostaglandin E urinary metabolites
Control group
Patients with abdominal pain in which acute appendicitis has been ruled out as a cause
Diagnostic test: Blood specimen collection
Blood specimen collection for analysis of C-reactive protein, white blood cell count and neutrophile count.
Diagnostic test: Urine collection
Urine sample collection for analysis of creatinine and prostaglandin E urinary metabolites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PGE-M
Time Frame: 72 hours
Levels of prostaglandin E urinary metabolite as measured with ELISA test
72 hours

Collaborators and Investigators

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

Sponsor

KBC Split

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 (Estimated)

June 2, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 29, 2025

First Submitted That Met QC Criteria

May 29, 2025

First Posted (Actual)

June 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181-147/01-06/LJ.Z.-25-02 (Registry Identifier: Ethics Committee of University Hospital Split)

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

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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