Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Temple University Health System (TUHS)

Status and phase

Withdrawn

Phase 2

Conditions

Esophageal Stenosis

Anastomotic Stenosis

Treatments

Drug: Mitomycin C

Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT04037072

18-1022

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.