Esophageal Cancer Clinical Trial

Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

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 topical application of normal saline (NS) or Mitomycin C (MMC) at the time of time of index procedure.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT04037072

Recruitment Status:

Withdrawn

Sponsor:

Fox Chase Cancer Center

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There is 1 Location for this study

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Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Study ID:

NCT04037072

Recruitment Status:

Withdrawn

Sponsor:


Fox Chase Cancer Center

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