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A randomized, open-labeled, parallel controlled study on the efficacy and safety of bleomycin and mitomycin combined with esophageal dilation in treatment of refractory strictures post-esophageal atresia repair in children

Multicenter randomized controlled experimental study on the safety and efficacy of mitomycin and bleomycin combined with esophageal dilation in the treatment of refractory esophageal stricture after esophageal atresia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058445
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-05-01
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Refractory esophageal stricture after esophageal atresia

Interventions

Group A:Mitomycin combined with esophageal dilation in the treatment of esophageal stricture
Group B:Bleomycin combined with esophageal dilation in the treatment of esophageal stricture

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. The patient was diagnosed with postoperative esophageal stricture following esophageal atresia repair at Capital Medical University Affiliated Beijing Children's Hospital, based on clinical evaluation and imaging studies. 2. According to the ESPGHAN-ESGE guidelines, it was in line with the diagnosis of refractory esophageal stricture, that is, 5 times of routine esophageal dilation have been performed, and the interval between each dilation is not more than 4 weeks, and age-appropriate feeding has still not been obtained, and there is an indication for combined gastroscopic drug injection; 3. Signed informed consent before the examination, surgery Consent and off-label medication.

Exclusion criteria

Exclusion criteria: 1. Those who underwent esophageal surgery during the study period; 2. Those who had serious underlying diseases and who could not tolerate gastroscope; 3. Those who had severe complications after esophageal atresia; 4. Those who had poor compliance with treatment or clinical research; 5. Those who refused to participate in this research.

Design outcomes

Primary

MeasureTime frame
Effectiveness of treatment;

Secondary

MeasureTime frame
Dysphagia score;Relative changes in the length of esophageal strictures;The relative change of lumen diameter of esophageal stricture;Use of anti-reflux medications;Number of esophageal dilations;Treatment costs;

Countries

China

Contacts

Public ContactJinshi Huang

Beijing Children's Hospital, Capital Medical University

jsdr2002@126.com+86 10 5961 6459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026