Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

NCT ID: NCT04037072

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-03
• Study Completion Date: 2022-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mitomycin C

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

Group Type: EXPERIMENTAL

Mitomycin C

Intervention Type: DRUG

Topical application of Mytomycin C (MMC)

Control

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Topical application of Normal Saline

Interventions

Mitomycin C

Topical application of Mytomycin C (MMC)

Intervention Type: DRUG

Control

Topical application of Normal Saline

Intervention Type: OTHER

Other Intervention Names

MMC; NS

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

18-1022

Identifier Type: -

Identifier Source: org_study_id