Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

Esophageal Stricture Clinical Trial

Official title:

The Clinical Efficacy of Endoscopic Postdilation Intralesional Injection of Mitomycin-C in Adults With Refractory Benign Esophageal Stricture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284826
• Other study ID #: AJIRB-MED-CT4-11-203
• Status: Completed
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2020
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Stenosis
• Esophageal Stricture

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months after mitomycin C injection
Primary	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	12 months after mitomycin C injection
Secondary	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	through study completion, an average of 1 year
Secondary	complications	endoscopic procedure-related adverse events	through study completion, an average of 1 year