Recruitment

Recruitment Status
Completed

Summary

Conditions
Esophageal Stricture
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal strictureMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 29 years and 75 years
Gender
Both males and females

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 esophag...

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.

Tracking Information

NCT #
NCT04284826
Collaborators
Not Provided
Investigators
Principal Investigator: Jin Hong Kim Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea