Anastomotic Stenosis, Esophageal Stenosis
Conditions
Keywords
Complex
Brief 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.
Interventions
DRUGMitomycin C
Topical application of Mytomycin C (MMC)
OTHERControl
Topical application of Normal Saline
Sponsors
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of dysphagia ≥ grade 1 after the dilation procedure | 6 months | Prevalence of dysphagia grade ≥1 in MMC Vs normal saline treated patients until 6 months after the first follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of procedures needed to reach dilation goal | 30 days | calculated from the first treatment procedure until the last one and will be compared between the experimental and the control arm. |
Countries
United States
Outcome results
None listed