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Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Temple University Health System (TUHS) logo

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Withdrawn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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups, including a placebo group

Mitomycin C
Experimental group
Description:
Cotton swab or strip of 2x2 cotton gauze soaked with 0.4mg/mL Mitomycin C
Treatment:
Drug: Mitomycin C
Control
Placebo Comparator group
Description:
Cotton swab or strip of 2x2 cotton gauze soaked with Normal saline
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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