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Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Primary Purpose

Esophageal Stenosis, Anastomotic Stenosis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Mitomycin C

Control

About this trial

This is an interventional treatment trial for Esophageal Stenosis focused on measuring Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mitomycin C

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04037072

First Posted

July 25, 2019

Last Updated

April 1, 2022

Sponsor

Fox Chase Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04037072

Brief Title

Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Study was not approved for Fox Chase Cancer Center's Research Review Committee (RRC)

Study Start Date

April 3, 2020 (Actual)

Primary Completion Date

March 15, 2022 (Anticipated)

Study Completion Date

December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fox Chase Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Stenosis, Anastomotic Stenosis

Keywords

Complex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mitomycin C

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Mitomycin C

Other Intervention Name(s)

MMC

Intervention Description

Topical application of Mytomycin C (MMC)

Intervention Type

Other

Intervention Name(s)

Control

Other Intervention Name(s)

Intervention Description

Topical application of Normal Saline

Primary Outcome Measure Information:

Title

Rate of dysphagia ≥ grade 1 after the dilation procedure

Description

Prevalence of dysphagia grade ≥1 in MMC Vs normal saline treated patients until 6 months after the first follow-up.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Number of procedures needed to reach dilation goal

Description

calculated from the first treatment procedure until the last one and will be compared between the experimental and the control arm.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

12. IPD Sharing Statement

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Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures

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