Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Esophageal Stenosis Clinical Trial

Official title:

GI-108: Randomized Controlled Double-Blinded Trial Assessing the Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04037072
• Other study ID #: 18-1022
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 3, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: April 2022
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Stenosis
• Constriction, Pathologic
• Esophageal Stenosis

Intervention

Drug:
• Mitomycin C
Topical application of Mytomycin C (MMC)

Other:
• Control
Topical application of Normal Saline

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of procedures needed to reach dilation goal	calculated from the first treatment procedure until the last one and will be compared between the experimental and the control arm.	30 days