Topical Mitomycin C for the Treatment of Complex Benign Esophageal Anastomotic Strictures, GI-108 Study

Inclusion Criteria

• Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
• Patients must have symptomatic (dysphagia >= 2), treatment naïve complex esophageal anastomotic stricture (length > 2 cm or diameter =< 9mm) or a recurrent or refractory stricture following maximal 1-3 endoscopic dilations
• 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. International normalized ratio (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 drugs 1 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
• Patients receiving systemic chemotherapy during the treatment of esophageal stricture