Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

Not Applicable

Completed

• Conditions: Esophageal Stricture
• Interventions: Procedure: Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture

• Registration Number: NCT04284826
• Lead Sponsor: Ajou University School of Medicine

Brief 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.

Study Timeline

• Study Start: 2013-10-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mitomycin C injection group	Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture	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

Primary Outcome Measures

Name	Time	Method
Overall clinical success of mitomycin C injection therapy	12 months after mitomycin C injection	The improvement of dysphagia score more than one point after once or even after over twice mitomycin C injection therapy during follow up period
Initial clinical success of mitomycin C injection therapy	12 months after mitomycin C injection	the improvement of dysphagia score more than one point after a single mitomycin C injection therapy during overall follow up period

Secondary Outcome Measures

Name	Time	Method
Technical success of mitomycin C injection therapy	through study completion, an average of 1 year	The successful performance of endoscopic mitomycin C injection into the submucosal layer at eight points of dilated stricture circumference after endoscopic dilation therapy
complications	through study completion, an average of 1 year	endoscopic procedure-related adverse events

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of