Status:

COMPLETED

Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

Lead Sponsor:

Ajou University School of Medicine

Conditions:

Esophageal Stricture

Eligibility:

All Genders

29-75 years

Phase:

NA

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 o...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 31 2018

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT04284826

Start Date

October 1 2013

End Date

August 31 2018

Last Update

February 28 2020

Active Locations (1)

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1

Ajou University Hospital

Suwon, South Korea, 443-721