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Esophageal stenting study for benign esophageal perforation and fistula

Phase II study to evaluate the safety and efficacy of esophageal stenting for benign esophageal perforation and fistula

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052240042
Enrollment
15
Registered
2024-05-24
Start date
2024-11-06
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Benign esophageal perforation or fistula Benign esophageal perforation or fistula

Interventions

Fully covered esophageal stents are placed to close benign esophageal perforations and fistulas. The stent is removed 2-4 weeks after stenting, and gastroenterography is performed to confirm closure o
Esophageal stent

Sponsors

Kanesaka Takashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are included 1) Benign esophageal perforation or fistula is confirmed by endoscopy. 2) Difficult to close with existing therapies. 3) No obvious abscess in the mediastinum or abdominal cavity. 4) The patient is at least 18 years of age at the time consent is obtained. 5) Written consent to participate in the study has been obtained from the patient.

Exclusion criteria

Exclusion criteria: Patients with any one of the following conditions are excluded 1) Systolic blood pressure less than 90 mmHg. 2) Pregnant women or patients who may be pregnant. 3) Other patients deemed inappropriate by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Clinical success rate

Secondary

MeasureTime frame
(1) Technical success rate (2) Stent-related adverse events (3) Stent migration rate (4) Hospital days after stenting

Contacts

Public ContactTakashi Kanesaka

Department of Gastrointestinal Oncology, Osaka International Cancer Institute

takashikanesaka@gmail.com+81-6-6945-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026