Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

NCT04284826 | Completed

• 1 other identifier: AJIRB-MED-CT4-11-203
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Stricture

Keywords

Esophageal Stricture; mitomycin C; endoscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Technical success of mitomycin C injection therapy

  through study completion, an average of 1 year

• complications

  through study completion, an average of 1 year

Study Arms (1)

mitomycin C injection group

EXPERIMENTAL

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

Interventions

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

mitomycin C injection group

Eligibility Criteria

• Age: 29 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, 443-721, South Korea

Location

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jin Hong Kim

  Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 26, 2020
• Study Start: October 1, 2013
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)