Diagnostic and Therapeutic Efficacy and… | Clinical Trial

Key information

Conditions

Small Bowel Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

single-bollon enteroscopy

Device

one group use single-balloon enteroscopy (SBE) in pediatric patients

double-bollon enteroscopy

Device

one group use double-bollon enteroscopy

Primary outcomes

diagnostic yield

Time frame: From Baseline to the finish of enteroscopy

Diagnostic yield was defined as the percentage of procedures with a disease-specific definitive endoscopic diagnosis.

Secondary outcomes

Positive rate

Time frame: from baseline to the finish of enterscopy

Positive rate as the proportion of patients with positive findings among all patients receiving BAE.
Complete enteroscopy

Time frame: start to the finish of the enteroscopy

Complete enteroscopy was defined as intubation of the entire small bowel by unidirectional (antegrade or retrograde route) or bidirectional enteroscopy.
Therapeutic yield

Time frame: frome baselin to finish of the enteroscopy

Therapeutic yield was defined as the proportion of enteroscopies in which a therapeutic intervention was undertaken.
procedure time

Time frame: from start to finish of the enteroscopy

from start to finish of the enteroscopy
adverse events

Time frame: From first day until 30 days

Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2024
Study completion: 2024
First posted: Feb 13, 2026
Registry last updated: Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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