Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

Ajou University School of Medicine16 enrolled

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Stricture

Interventions

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

Eligibility

Sex: ALLMin age: 29 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Ajou University Hospital

Suwon, South Korea

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 12 months after mitomycin C injection

Secondary Outcomes

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

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

complications

endoscopic procedure-related adverse events

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

Data from ClinicalTrials.gov

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