Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

Study Overview
=================
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.

Official Title
-----------------
The Clinical Efficacy of Endoscopic Postdilation Intralesional Injection of Mitomycin-C in Adults With Refractory Benign Esophageal Stricture

Conditions
-----------------
Esophageal Stricture

Intervention / Treatment
-----------------
* Procedure: Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mitomycin C injection group<br>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 | Procedure: Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months after mitomycin C injection | 
| 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 | 12 months after mitomycin C injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion, an average of 1 year | 
| complications | endoscopic procedure-related adverse events | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Stricture, mitomycin C, endoscopy