Balloon-Assisted Enteroscopic Treatment for Phytobezoar

March 10, 2025 updated by: Xiuli Zuo, Shandong University

Analysis of the Safety and Efficacy of Balloon-Assisted Enteroscopic Treatment for Phytobezoar

By reviewing a case series of patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital, we analyzed the safety and efficacy of this technique.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

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
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University

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

N/A

Sampling Method

Non-Probability Sample

Study Population

patients with small intestinal phytobezoar

Description

Inclusion Criteria:

  • Retrospectively collect data from patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital.

Exclusion Criteria:

  • Patients with incomplete clinical data.

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
Patients who underwent balloon-assisted enteroscopic treatment for phytobezoar
Patient information was retrieved and collected through the HIS (Hospital Information System) and endoscopy system of Qilu Hospital of Shandong University, followed by statistical analysis. The collected information includes: gender, age, comorbid conditions, symptoms, time of onset, laboratory test results, time of small intestinal endoscopy, description of endoscopic procedures, success of the procedure, whether sodium bicarbonate was injected, presence of complications during treatment, length of hospital stay, and days from surgery to discharge.
Other: balloon-assisted enteroscopic treatment for phytobezoar
The endoscopists applied balloon-assisted enteroscopy for the treatment of the phytobezoar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Balloon-Assisted Enteroscopic treatment for Phytobezoar
Time Frame: 3 months
Success Rate of the Procedure
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Balloon-Assisted Enteroscopic treatment for Phytobezoar
Time Frame: 3 months
Incidence of Complications
3 months

Collaborators and Investigators

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

Sponsor

Shandong University

Investigators

  • Study Director: Xiuli Zuo, Qilu Hospital of Shandong 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)

December 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-SDU-Qilu-02

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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