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Trans-illumination Technique for Pediatric Post-pyloric Tube Placement: a pilot study

Single-arm exploratory clinical study on the efficacy and safety of the trans-illuminated guide fiber "Tumguide" in pediatric post-pyloric tube placement - TIPP study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032250813
Enrollment
50
Registered
2026-03-16
Start date
2026-03-16
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pediatric patients requiring post-pyloric nutrition under intensive care or with feeding intolerance

Interventions

The trans-illuminated guide fiber "Tumguide" is used in post-pyloric tube placement procedures for pediatric patients requiring post-pyloric nutrition (including critically ill patients and those with

Sponsors

Ebishima Hironori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients clinically determined to require post-pyloric feeding (2) Age: Patients under 18 years old at the time of obtaining consent (3) Patients aged 6 months or older at the time of obtaining consent, or if younger than 6 months, patients with a corrected age of >= 37 weeks (4) Weight is >= 2,500g (5) Sex: Both (6) Patients for whom written voluntary consent has been obtained from the patient or their legally acceptable representative after receiving a full explanation and understanding of participation in this study (7) Patients determined by the principal investigator or sub-investigator to be in a general condition capable of enduring the study procedure and 24-hour observation after the procedure

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications for enteral nutrition, such as gastrointestinal perforation, ileus, or peritonitis (2) Patients with structural abnormalities that would make post-pyloric tube placement significantly difficult, such as duodenal atresia (including post-operative status) (3) Patients whose hemodynamic or respiratory status is significantly unstable and for whom the procedure is judged likely to cause deterioration (e.g., shock, severe hypoxemia, frequent arrhythmia) (4) Patients with severe bleeding tendency (5) Patients with a history of severe complications caused by post-pyloric tube placement procedures (6) Other patients judged by the principal investigator or sub-investigator to be unsuitable for participation in this study

Design outcomes

Primary

MeasureTime frame
Success rate of post-pyloric tube placement confirmed by the initial X-ray image after completion of the insertion procedure

Secondary

MeasureTime frame
(1) Time required for the procedure until successful placement (2) Success rate of post-pyloric placement using rescue procedure (3) Frequency and proportion of adverse events related to the procedure

Contacts

Public ContactHidehito oota

The University of Tokyo Hospital

hioota-tky@umin.ac.jp+81-338155411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026