Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

Overview

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.

Full Title of Study: “The Clinical Efficacy of Endoscopic Postdilation Intralesional Injection of Mitomycin-C in Adults With Refractory Benign Esophageal Stricture”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2018

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.

Interventions

  • Procedure: Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture

Arms, Groups and Cohorts

  • Experimental: mitomycin C injection group
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Initial clinical success of mitomycin C injection therapy
    • Time Frame: 12 months after mitomycin C injection
    • 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
    • Time Frame: 12 months after mitomycin C injection
    • 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 Measures

  • Technical success of mitomycin C injection therapy
    • Time Frame: through study completion, an average of 1 year
    • The successful performance of endoscopic mitomycin C injection into the submucosal layer at eight points of dilated stricture circumference after endoscopic dilation therapy
  • complications
    • Time Frame: through study completion, an average of 1 year
    • endoscopic procedure-related adverse events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 29 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ajou University School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin Hong Kim, Professor – Ajou University School of Medicine
  • Overall Official(s)
    • Jin Hong Kim, Principal Investigator, Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea

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