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

Esophageal stenting study for benign esophageal perforation and fistula

Kanesaka Takashi

Department of Gastrointestinal Oncology, Osaka International Cancer Institute

3-1-69, Otemae, Chuo-ku, Osaka, Osaka

takashikanesaka@gmail.com

Kanesaka Takashi

Department of Gastrointestinal Oncology, Osaka International Cancer Institute

3-1-69, Otemae, Chuo-ku, Osaka, Osaka

+81-6-6945-1181

takashikanesaka@gmail.com

Recruiting

May. 24, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Benign esophageal perforation or fistula

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.

Benign esophageal perforation or fistula

Esophageal stent

Clinical success rate

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

+81-6-6945-1181

May. 22, 2024

None