Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

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

Study Overview

• Status: Completed
• Conditions: Esophageal Stricture
• Intervention / Treatment: Procedure: Endoscopic injection of Mitomycin-C on bougie-dilated 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 443-721
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Jin Hong Kim, Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: endoscopy; Esophageal Stricture; mitomycin C
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Constriction, Pathologic; Esophageal Stenosis; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: AJIRB-MED-CT4-11-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No