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Mitomycin-C Injection Therapy in Refractory Esophageal Stricture

NCT ID: NCT04284826

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-01

Study Completion Date

2018-08-31

Brief Summary

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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

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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

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Esophageal Stricture

Keywords

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Esophageal Stricture mitomycin C endoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mitomycin C injection group

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

29 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jin Hong Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Hong Kim

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea

Locations

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Ajou University Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJIRB-MED-CT4-11-203

Identifier Type: -

Identifier Source: org_study_id