Clinical trial NCT04037072: Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures
Official title: GI-108: Randomized Controlled Double-Blinded Trial Assessing the Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Esophageal Stenosis
Anastomotic Stenosis
Keywords: Complex
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of dysphagia ≥ grade 1 after the dilation procedure
timeFrame: 6 months
Secondary outcomes:
measure: Number of procedures needed to reach dilation goal
timeFrame: 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: