Risk Factors and Predictive Model for Inflammatory Polyps in Ureteral Stones (UROLITH-POLYP)

June 4, 2026 updated by: Yanbo Wang, The First Hospital of Jilin University

Risk Factors and Development of a Predictive Model for Stone-Associated Inflammatory Ureteral Polyps: A Retrospective Cohort Study With Prospective Validation

This is a single-center, observational study including a retrospective cohort and a prospective validation cohort. The study aims to identify independent risk factors for inflammatory ureteral polyps in patients with ureteral calculi and develop a preoperative predictive model. The retrospective part will analyze clinical and imaging data of patients treated at the First Hospital of Jilin University between 2018 and 2025. The prospective part is currently recruiting participants to validate the model. The primary outcome is the intraoperative diagnosis of inflammatory ureteral polyps.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a bicentric bidirectional cohort study; retrospective cohort (n=629) has been fully enrolled, prospective cohort is ongoing consecutive enrollment.

Study Type

Observational

Enrollment (Estimated)

779

Contacts and Locations

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

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population includes adult patients with ureteral calculi who underwent ureteroscopic treatment at the First Hospital of Jilin University. The retrospective cohort includes patients treated between 2018 and 2025, and the prospective cohort is recruiting new patients for validation.

Description

Inclusion Criteria:

  • Patients aged 18 years or older undergoing ureteroscopic surgery for ureteral calculi at the First Hospital of Jilin University.
  • Complete clinical and imaging data available.

Exclusion Criteria:

  • Patients with bilateral ureteral calculi.
  • Patients with preoperative nephrostomy or indwelling ureteral stent.
  • Patients with a history of ureteral or bladder cancer.
  • Patients with congenital ureteral anomalies or previous ureteral surgery.
  • Patients with severe coagulation disorders or contraindications to ureteroscopy.
  • Patients unable to provide informed consent.

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
Retrospective Cohort
This retrospective cohort consecutively enrolled 629 patients with ureteral calculi receiving surgical management from Jan 1, 2018 to Dec 31, 2025 at the First Hospital of Jilin University. Complete preoperative clinical and radiological data were extracted to screen independent risk factors for inflammatory ureteral polyps and construct a predictive logistic model.
Prospective Validation Cohort
This prospective validation cohort plans to consecutively recruit 150 eligible ureteral calculi patients from Mar 1, 2026 to Feb 1, 2027 to externally validate the preoperative predictive model derived from retrospective cohort data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Intraoperatively Confirmed Inflammatory Ureteral Polyps
Time Frame: At the time of ureteroscopic surgery
The primary outcome is the presence or absence of inflammatory ureteral polyps confirmed by intraoperative pathology or direct visualization during ureteroscopy.
At the time of ureteroscopic surgery

Collaborators and Investigators

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

Sponsor

The First Hospital of Jilin University

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, 2018

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLU-FH-2026-UROLITH-001

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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