Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

Ajou University School of Medicine

Status: Completed

Conditions: Esophageal Stricture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04284826

AJIRB-MED-CT4-11-203

Details and patient eligibility

About

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 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.

Enrollment: 16 patients

Sex: All

Ages: 29 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

mitomycin C injection group

Experimental group

Description:

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

Treatment:

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