Esophageal stenting study for benign esophageal perforation and fistula

JRCT ID: jRCTs052240042

Registered date:24/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Benign esophageal perforation or fistula
• Date of first enrollment: 24/05/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): 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 of the perforation or fistula.

Outcome(s)

• Primary Outcome: Clinical success rate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kanesaka Takashi