Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

NCT04037072 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 18-1022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Stenosis; Anastomotic Stenosis

Keywords

Complex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of procedures needed to reach dilation goal

  30 days

Study Arms (2)

Mitomycin C

EXPERIMENTAL

Cotton swab or strip of 2x2 cotton gauze soaked with 0.4mg/mL Mitomycin C

Drug: Mitomycin C

Control

PLACEBO COMPARATOR

Cotton swab or strip of 2x2 cotton gauze soaked with Normal saline

Other: Control

Interventions

Mitomycin C DRUG

Topical application of Mytomycin C (MMC)

Also known as: MMC

Mitomycin C

Control OTHER

Topical application of Normal Saline

Also known as: NS

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Esophageal Stenosis

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 30, 2019
• Study Start: April 3, 2020
• Primary Completion: March 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

US (1)