Esophageal StrictureNCT04284826
Mitomycin-C Injection Therapy in Refractory Esophageal Stricture
A study testing Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture in people with Esophageal Stricture, run by Ajou University School of Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 29 to 75 years
- Conditions the study is for
- Esophageal Stricture
- What is being tested?
- Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2013to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Efficacy of Endoscopic Postdilation Intralesional Injection of Mitomycin-C in Adults With Refractory Benign Esophageal Stricture
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.
Read the 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.
- Conditions
- Esophageal Stricture
- Being tested
- Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture
- Keywords
- Esophageal Stricture, mitomycin C, endoscopy
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal strictureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| mitomycin C injection group | Experimental | 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 Receives: Procedure: Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after mitomycin C injection
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
Measured: 12 months after mitomycin C injection
Secondary outcomes (2)
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
Measured: through study completion, an average of 1 year
complications
endoscopic procedure-related adverse events
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Oct 2013
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Hong Kim, Ajou University School of Medicine
- Investigators
- Jin Hong Kim, Principal investigator, Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284826
- Sponsor's protocol ID
- AJIRB-MED-CT4-11-203
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Endoscopic Postdilation Intralesional Injection of Mitomycin-C in Adults With Refractory Benign Esophageal Stricture
- ClinicalTrials.gov ID
- NCT04284826
- Acronym / sponsor ID
- AJIRB-MED-CT4-11-203
- Conditions
- Esophageal Stricture
- Keywords
- Esophageal Stricture, mitomycin C, endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
| Arm | Type | Receives |
|---|---|---|
| mitomycin C injection group | Experimental | Procedure: Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal strictureA 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 |
Who may qualify
- Ages
- 29 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture | Procedure or surgery | mitomycin C injection group |
Primary outcome
Initial clinical success of mitomycin C injection therapy
Time frame: 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
Overall clinical success of mitomycin C injection therapy
Time frame: 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
2 secondary outcomes
Technical success of mitomycin C injection therapy
Time frame: through study completion, an average of 1 year
complications
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Hong Kim principal investigator
Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture in people with Esophageal Stricture, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial clinical success of mitomycin C injection therapy (time frame: 12 months after mitomycin C injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.