Skip to main content
OpenTrials
Completed

NCT Number: NCT04284826

Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Esophageal Stricture Digestive System Diseases Esophageal Diseases Esophageal Stenosis Gastrointestinal Diseases

Age range

29 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, 443-721, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. complications

    Time frame: through study completion, an average of 1 year

    endoscopic procedure-related adverse events

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2020
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.