Diagnostic and Therapeutic Efficacy and Safety of Enteroscopy in Pediatric Patients

Diagnostic and Therapeutic Efficacy and Safety of Single- and Double-balloon Enteroscopy in Pediatric Patients: An Inverse Probability of Treatment-weighted Cohort Study

The aim of our study was to compare the utility and safety of SBE and DBE in pediatric patients.

Study Overview

• Status: Completed
• Conditions: Small Bowel Diseases
• Intervention / Treatment: Device: single-bollon enteroscopy; Device: double-bollon enteroscopy

Detailed Description

The benefit of balloon-assisted enteroscopy (BAE) had been recently documented in pediatric patients, but no study has compared the use of single-balloon enteroscopy (SBE) and double-balloon enteroscopy (DBE) in pediatric patients to date. The aim of our study was to compare the utility and safety of SBE and DBE in pediatric patients. This retrospective study enrolled patients younger than 18 years between January 2015 and May 2024. Inverse probability of treatment-weighted (IPTW) adjustment was used to address the imbalance in variables. The outcomes included diagnostic yield, positive rate, complete enteroscopy, therapeutic yield, procedure times and complications.

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

pediatric patients (≤18 years) with suspected small bowel disease who underwent BAE

Description

Inclusion Criteria:

• This study retrospectively collected clinical data and endoscopic information of pediatric patients (≤18 years) with suspected small bowel disease who underwent BAE consecutively at a tertiary medical center (Qilu Hospital of Shandong University, Jinan, China) from January 2015 to May 2024.

Exclusion Criteria: (1) refusal for consent; (2) contraindication for deep sedation; (3) patients with incomplete clinical data and endoscopic information; (4) oral enteroscopy cannot pass the pylorus, and anal enteroscopy cannot pass the ileocecal valve.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SBE group	Device: single-bollon enteroscopy; one group use single-balloon enteroscopy (SBE) in pediatric patients
DBE group	Device: double-bollon enteroscopy; one group use double-bollon enteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic yield	Diagnostic yield was defined as the percentage of procedures with a disease-specific definitive endoscopic diagnosis.	From Baseline to the finish of enteroscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate	Positive rate as the proportion of patients with positive findings among all patients receiving BAE.	from baseline to the finish of enterscopy
Complete enteroscopy	Complete enteroscopy was defined as intubation of the entire small bowel by unidirectional (antegrade or retrograde route) or bidirectional enteroscopy.	start to the finish of the enteroscopy
Therapeutic yield	Therapeutic yield was defined as the proportion of enteroscopies in which a therapeutic intervention was undertaken.	frome baselin to finish of the enteroscopy
procedure time	from start to finish of the enteroscopy	from start to finish of the enteroscopy
adverse events	Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy.	From first day until 30 days

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KYLL-202404-034

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