Status:
WITHDRAWN
Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Esophageal Stenosis
Anastomotic Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study evaluates Mitomycin C as treatment for dysphagia in adult subjects with documented complex esophageal anastomotic strictures. Patients will be randomized in a double-blinded fashion to topi...
Eligibility Criteria
Inclusion
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- Patients must have symptomatic (dysphagia ≥2), treatment naïve complex esophageal anastomotic stricture (length \>2 cm or diameter ≤9mm).
- Age ≥ 18
- Esophago-gastro or esophago-jejunal anastomosis with or without having undergone neoadjuvant or adjuvant radio-chemotherapy
- Any patient taking antiplatelet agents such as Plavix, Effient, Brilinta, Aggrenox must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation.
- Any patient on vitamin K antagonists such as warfarin must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation. INR should be checked for such patients at least 24 hours before dilation and it must be \< 1.5
- Patients taking direct thrombin inhibitors such as Pradaxa, Angiomax must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation
- Patients taking Factor Xa inhibitors must be able to hold the drugs 2 days prior to dilation and may resume 3 days after dilation
- Patients taking GIIB/IIIA inhibitors must be able to hold the drugs1 day prior to dilation and resume 3 days after the dilation.
- Patients taking unfractionated heparin must be able to hold the drug 6 hours before dilation and low molecular weight heparin must be held 24 hours before dilation. Unfractionated heparin may resume immediately after the dilation while low molecular weight heparin may resume 3 days after dilation
Exclusion
- Patients with malignant strictures
- Patients with non-complex benign strictures.
- Patients with anastomosis creation within ≤ 2 weeks
- Patients with suspected gastrointestinal perforation or leak that could result in extraluminal extravasation of Mitomycin C
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breast feeding. Refer to section 4.4 for further detail.
- Patients receiving systemic chemotherapy during the treatment of esophageal stricture.
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04037072
Start Date
April 3 2020
End Date
December 15 2022
Last Update
April 11 2022
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111