Small Bowel DiseasesNCT07410026
Diagnostic and Therapeutic Efficacy and Safety of Enteroscopy in Pediatric Patients
An observational study of Small Bowel Diseases, run by Shandong University at 1 site in China.
Trial summary
The aim of our study was to compare the utility and safety of SBE and DBE in pediatric patients. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Small Bowel Diseases
- What is being tested?
- single-bollon enteroscopy and double-bollon enteroscopy
- Type of treatment
- Medical device
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients (≤18 years) with suspected small bowel disease who underwent BAE
Who may be able to join
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Small Bowel Diseases
- Being tested
- single-bollon enteroscopy, double-bollon enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-bollon enteroscopyDevice
one group use single-balloon enteroscopy (SBE) in pediatric patients
double-bollon enteroscopyDevice
one group use double-bollon enteroscopy
| Study group | Role | What they receive |
|---|---|---|
| SBE group | Not described Receives: Device: single-bollon enteroscopy | |
| DBE group | Not described Receives: Device: double-bollon enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic yield
Diagnostic yield was defined as the percentage of procedures with a disease-specific definitive endoscopic diagnosis.
Measured: From Baseline to the finish of enteroscopy
Secondary outcomes (5)
Positive rate
Positive rate as the proportion of patients with positive findings among all patients receiving BAE.
Measured: 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.
Measured: 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.
Measured: frome baselin to finish of the enteroscopy
procedure time
from start to finish of the enteroscopy
Measured: 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.
Measured: From first day until 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jan 2015
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410026
- Sponsor's protocol ID
- KYLL-202404-034
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Therapeutic Efficacy and Safety of Single- and Double-balloon Enteroscopy in Pediatric Patients: An Inverse Probability of Treatment-weighted Cohort Study
- ClinicalTrials.gov ID
- NCT07410026
- Acronym / sponsor ID
- KYLL-202404-034
- Conditions
- Small Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBE group | – | Device: single-bollon enteroscopy |
| DBE group | – | Device: double-bollon enteroscopy |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients (≤18 years) with suspected small bowel disease who underwent BAE
Key inclusion criteria (3 listed)
- 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.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single-bollon enteroscopyone group use single-balloon enteroscopy (SBE) in pediatric patients | Device | SBE group |
| double-bollon enteroscopyone group use double-bollon enteroscopy | Device | DBE group |
Primary outcome
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.
5 secondary outcomes
Positive rate
Time frame: from baseline to the finish of enterscopy
Complete enteroscopy
Time frame: start to the finish of the enteroscopy
Therapeutic yield
Time frame: frome baselin to finish of the enteroscopy
procedure time
Time frame: from start to finish of the enteroscopy
adverse events
Time frame: From first day until 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Small Bowel Diseases
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Diseases, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic yield (time frame: From Baseline to the finish of enteroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.