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Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037072
Recruitment Status : Suspended (Due to COVID-19)
First Posted : July 30, 2019
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

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.

Condition or disease Intervention/treatment Phase
Esophageal Stenosis Anastomotic Stenosis Drug: Mitomycin C Other: Control Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GI-108: Randomized Controlled Double-Blinded Trial Assessing the Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mitomycin C
Cotton swab or strip of 2x2 cotton gauze soaked with 0.4mg/mL Mitomycin C
Drug: Mitomycin C
Topical application of Mytomycin C (MMC)
Other Name: MMC

Placebo Comparator: Control
Cotton swab or strip of 2x2 cotton gauze soaked with Normal saline
Other: Control
Topical application of Normal Saline
Other Name: NS




Primary Outcome Measures :
  1. Rate of dysphagia ≥ grade 1 after the dilation procedure [ Time Frame: 6 months ]
    Prevalence of dysphagia grade ≥1 in MMC Vs normal saline treated patients until 6 months after the first follow-up.


Secondary Outcome Measures :
  1. Number of procedures needed to reach dilation goal [ Time Frame: 30 days ]
    calculated from the first treatment procedure until the last one and will be compared between the experimental and the control arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037072


Locations
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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT04037072    
Other Study ID Numbers: 18-1022
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fox Chase Cancer Center:
Complex
Additional relevant MeSH terms:
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Esophageal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors