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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07410026
Enrollment
208
Registered
2026-02-13
Start date
2015-01-01
Completion date
2024-05-30
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Bowel Diseases

Brief summary

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

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.

Interventions

DEVICEsingle-bollon enteroscopy

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

DEVICEdouble-bollon enteroscopy

one group use double-bollon enteroscopy

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
diagnostic yieldFrom Baseline to the finish of enteroscopyDiagnostic yield was defined as the percentage of procedures with a disease-specific definitive endoscopic diagnosis.

Secondary

MeasureTime frameDescription
Positive ratefrom baseline to the finish of enterscopyPositive rate as the proportion of patients with positive findings among all patients receiving BAE.
Complete enteroscopystart to the finish of the enteroscopyComplete enteroscopy was defined as intubation of the entire small bowel by unidirectional (antegrade or retrograde route) or bidirectional enteroscopy.
Therapeutic yieldfrome baselin to finish of the enteroscopyTherapeutic yield was defined as the proportion of enteroscopies in which a therapeutic intervention was undertaken.
procedure timefrom start to finish of the enteroscopyfrom start to finish of the enteroscopy
adverse eventsFrom first day until 30 daysAdverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026