Clinical trial NCT04284826: Mitomycin-C Injection Therapy in Refractory Esophageal Stricture
Official title: The Clinical Efficacy of Endoscopic Postdilation Intralesional Injection of Mitomycin-C in Adults With Refractory Benign Esophageal Stricture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Stricture
Keywords: Esophageal Stricture
mitomycin C
endoscopy
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 16
Sex: ALL
Minimum age (years): 29
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Initial clinical success of mitomycin C injection therapy
timeFrame: 12 months after mitomycin C injection
measure: Overall clinical success of mitomycin C injection therapy
timeFrame: 12 months after mitomycin C injection
Secondary outcomes:
measure: Technical success of mitomycin C injection therapy
timeFrame: through study completion, an average of 1 year
measure: complications
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
name: Jin Hong Kim
role: PRINCIPAL_INVESTIGATOR
References: