Topical Mitomycin C for the Treatment of Complex Benign Esophageal Anastomotic Strictures, GI-108 Study
- 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
- 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
I. To compare the rate of dysphagia >= grade 1 after the dilation procedure when 15mm dilation and zero dysphagia was achieved in patients treated with mitomycin C versus (vs) normal saline until 6 months after the first follow-up.
I. Number of procedures needed to reach dilation goal of at least 15mm and zero dysphagia in control vs mitomycin C treated patients.
II. Overall adverse events in mitomycin C vs control treated patients.
III. To evaluate the reliability of dysphagia symptoms by completing Mayo Dysphagia Questionnaire-30day (MDQ-30).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care esophagogastroduodenoscopy (EGD), then receive mitomycin C topically via endoscope over 3 minutes in each quadrant. If dilation of 15 mm is not achieved and dysphagia persists, patients undergo additional EGD every 2 weeks for a maximum of 4 EGD procedures.
ARM II: Patients undergo standard of care EGD, then receive normal saline topically via endoscope over 3 minutes in each quadrant. If dilation of 15 mm is not achieved and dysphagia persists, patients undergo additional EGD every 2 weeks for a maximum of 4 EGD procedures.
After completion of study treatment, patients are followed up at 30 days, 4 weeks, and 6 months.
Trial Phase Phase II
Trial Type Treatment
Fox Chase Cancer Center
- Primary ID GI-108
- Secondary IDs NCI-2020-05889, 18-1022
- Clinicaltrials.gov ID NCT04037072