Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures (NCT04037072) | Clinical Trial Compass
WithdrawnPhase 2
Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures
Stopped: Study was not approved for Fox Chase Cancer Center's Research Review Committee (RRC)
United States0Started 2020-04-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 whil…
What they're measuring
1
Rate of dysphagia ≥ grade 1 after the dilation procedure