NCT04284826

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 29 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Esophageal Stricture

Interventions

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

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-08-31
• Completion: 2018-08-31
• First posted: 2020-02-26
• Last updated: 2020-02-28

Locations

1 site across 1 country: South Korea