Back to resultsMitomycin-C Injection Therapy in Refractory Esophageal Stricture
Primary Purpose
Esophageal Stricture
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Stricture focused on measuring Esophageal Stricture, mitomycin C, endoscopy
Eligibility Criteria
Inclusion Criteria:
- aged more than 29 year and less than 75 year
- refractory benign esophageal stricture who had the symptoms of dysphagia score suggested by Mellow et al greater than 3 (0: able to eat a normal diet, 1: able to eat some solid food, 2: able to eat some semi-solids only, 3: able to swallow liquids only, 4: complete dysphagia)
Exclusion Criteria: Patients who have at least one of following conditions were excluded from our study
- malignant esophageal stricture
- multiple sites of esophageal stricture
- pregnant or breast feeding status
- clinical deterioration not tolerated to endoscopic procedures
- esophageal motility disorders
- esophageal leakage or fistula
- hypersensitivity to mitomycin C
- bleeding tendency due to thrombocytopenia or clotting disorders
Sites / Locations
- Ajou University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mitomycin C injection group
Arm Description
A submucosal needle injection of 4mL of a MMC preparation (0.5mg/mL) into the tearing esophageal wall after esophageal bougie dilation on refractory benign esophageal stricture
Outcomes
Primary Outcome Measures
Initial clinical success of mitomycin C injection therapy
the improvement of dysphagia score more than one point after a single mitomycin C injection therapy during overall follow up period
Overall clinical success of mitomycin C injection therapy
The improvement of dysphagia score more than one point after once or even after over twice mitomycin C injection therapy during follow up period
Secondary Outcome Measures
Technical success of mitomycin C injection therapy
The successful performance of endoscopic mitomycin C injection into the submucosal layer at eight points of dilated stricture circumference after endoscopic dilation therapy
complications
endoscopic procedure-related adverse events
Full Information
NCT ID
NCT04284826
First Posted
February 23, 2020
Last Updated
February 26, 2020
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04284826
Brief Title
Mitomycin-C Injection Therapy in Refractory Esophageal Stricture
Official Title
The Clinical Efficacy of Endoscopic Postdilation Intralesional Injection of Mitomycin-C in Adults With Refractory Benign Esophageal Stricture
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intralesional Mitomycin-C (MMC) injection has recently been introduced to resolve refractory benign esophageal stricture mostly in children. The investigators aimed to evaluate the clinical efficacy of endoscopic postdilation intralesional injection of MMC in adults with refractory benign esophageal stricture.
Detailed Description
The participnts who have refractory benign esophageal stricture even after five or more sessions of bougination are prospectively enrolled. A submucosal needle injection of 4mL of a MMC preparation (0.5mg/mL) is endoscopically done with a 0.5mL of eight each injection mainly into the tearing esophageal wall, after esophageal bougie dilation is done upto 14mm in diameter. And then, repeated bouginations combined with MMC injection are done with the interval of eight weeks upto 3 times, if dysphagia symptoms recurr with dysphagis score 3 or more. Initial and overall clinical success rates are evaluated with drug and procedure-related complication rates during the follow-up period of at least 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stricture
Keywords
Esophageal Stricture, mitomycin C, endoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mitomycin C injection group
Arm Type
Experimental
Arm Description
A submucosal needle injection of 4mL of a MMC preparation (0.5mg/mL) into the tearing esophageal wall after esophageal bougie dilation on refractory benign esophageal stricture
Intervention Type
Procedure
Intervention Name(s)
Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture
Primary Outcome Measure Information:
Title
Initial clinical success of mitomycin C injection therapy
Description
the improvement of dysphagia score more than one point after a single mitomycin C injection therapy during overall follow up period
Time Frame
12 months after mitomycin C injection
Title
Overall clinical success of mitomycin C injection therapy
Description
The improvement of dysphagia score more than one point after once or even after over twice mitomycin C injection therapy during follow up period
Time Frame
12 months after mitomycin C injection
Secondary Outcome Measure Information:
Title
Technical success of mitomycin C injection therapy
Description
The successful performance of endoscopic mitomycin C injection into the submucosal layer at eight points of dilated stricture circumference after endoscopic dilation therapy
Time Frame
through study completion, an average of 1 year
Title
complications
Description
endoscopic procedure-related adverse events
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged more than 29 year and less than 75 year
refractory benign esophageal stricture who had the symptoms of dysphagia score suggested by Mellow et al greater than 3 (0: able to eat a normal diet, 1: able to eat some solid food, 2: able to eat some semi-solids only, 3: able to swallow liquids only, 4: complete dysphagia)
Exclusion Criteria: Patients who have at least one of following conditions were excluded from our study
malignant esophageal stricture
multiple sites of esophageal stricture
pregnant or breast feeding status
clinical deterioration not tolerated to endoscopic procedures
esophageal motility disorders
esophageal leakage or fistula
hypersensitivity to mitomycin C
bleeding tendency due to thrombocytopenia or clotting disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Hong Kim
Organizational Affiliation
Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mitomycin-C Injection Therapy in Refractory Esophageal Stricture
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