Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Study Overview
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Brief Summary
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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.

Official Title
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GI-108: Randomized Controlled Double-Blinded Trial Assessing the Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Conditions
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Esophageal Stenosis, Anastomotic Stenosis

Intervention / Treatment
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* Drug: Mitomycin C
* Other: Control


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitomycin C<br>Cotton swab or strip of 2x2 cotton gauze soaked with 0.4mg/mL Mitomycin C | Drug: Mitomycin C<br>* Topical application of Mytomycin C (MMC)<br>* Other names: MMC;|
| Placebo Comparator: Control<br>Cotton swab or strip of 2x2 cotton gauze soaked with Normal saline | Other: Control<br>* Topical application of Normal Saline<br>* Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of dysphagia ≥ grade 1 after the dilation procedure | Prevalence of dysphagia grade ≥1 in MMC Vs normal saline treated patients until 6 months after the first follow-up. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedures needed to reach dilation goal | calculated from the first treatment procedure until the last one and will be compared between the experimental and the control arm. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complex