Esophageal StrictureNCT03039608
Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm
A study testing combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） and oral steroid administration（prednisone） in people with Esophageal Stricture, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently these years especially in Asian countries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Stricture
- What is being tested?
- combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） and oral steroid administration（prednisone）
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2017to 10 Nov 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who has undergone esophageal ESD
- Histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus
- ESD resulted in a mucosal defect involving more than two-thirds of the esophageal circumference.
Who cannot join
- Severe circulatory or respiratory disease，severe renal impairment
- Women in pregnancy and lactation
- Patients with steroid contraindications
- Patients refuse to join in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm：a Randomized Controlled Trial
The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently these years especially in Asian countries. However, besides of perforation and bleeding, another complication postoperative esophageal stricture is frequently observed after the removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative stricture substantially decreases the patient's quality of life, requiring further therapy. Although the exact incidence is unknown, esophageal stricture is supposed to be related to the extent of the circumference being resected. In previous study by Ono et al，it is reported that 90% of patients with lesions of circumferential extension of more than three-fourths experienced postoperative stricture after esophageal ESD. There were some reported studies exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled that just oral prednisolone oral is effective option for the prevention of post-ESD stricture. However, most of the reported studies were non RCTs with small sample. In the primary study, the investigators search a new method of combination of both oral and local injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic effects of combination of local steroid injection with oral steroid administration for esophageal stenoses complicating extensive ESD.
- Conditions
- Esophageal Stricture
- Being tested
- combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）, oral steroid administration（prednisone）
- Keywords
- esophageal stricture, endoscopic submucosal dissection, prevention
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）Drug
local steroid injection and oral steroid
oral steroid administration（prednisone）Drug
oral steroid
| Study group | Role | What they receive |
|---|---|---|
| combination group | Experimental | combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） Receives: Drug: combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） |
| control group | Active comparator | oral steroid administration（prednisone） Receives: Drug: oral steroid administration（prednisone） |
What is being measured
The primary outcome is the main question the study is designed to answer.
the stricture rate
the incidence of esophageal rate after ESD
Measured: 12weeks
the time when stricture occurs
Measured: 12weeks
Secondary outcomes (2)
the frequency of dilatation sessions required
the frequency of dilatation sessions required after stricture
Measured: 12 months
the frequency of complications
complications related with steroid administrations or the process of ESD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start10 Feb 2017
- Primary completion10 Jul 2018
- Study completion10 Nov 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.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meidong Xu, PhD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039608
- Sponsor's protocol ID
- xmdrct
- Status last verified
- Sep 2019
- First submitted
- 26 Jan 2017
- Last updated
- 4 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03039608
- Acronym / sponsor ID
- xmdrct
- Conditions
- Esophageal Stricture
- Keywords
- esophageal stricture, endoscopic submucosal dissection, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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.
The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently these years especially in Asian countries. However, besides of perforation and bleeding, another complication postoperative esophageal stricture is frequently observed after the removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative stricture substantially decreases the patient's quality of life, requiring further therapy. Although the exact incidence is unknown, esophageal stricture is supposed to be related to the extent of the circumference being resected. In previous study by Ono et al，it is reported that 90% of patients with lesions of circumferential extension of more than three-fourths experienced postoperative stricture after esophageal ESD. There were some reported studies exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled that just oral prednisolone oral is effective option for the prevention of post-ESD stricture. However, most of the reported studies were non RCTs with small sample. In the primary study, the investigators search a new method of combination of both oral and local injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic effects of combination of local steroid injection with oral steroid administration for esophageal stenoses complicating extensive ESD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination group | Experimental | Drug: combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） |
| control group | Active comparator | Drug: oral steroid administration（prednisone）oral steroid administration（prednisone） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who has undergone esophageal ESD
- Histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus
- ESD resulted in a mucosal defect involving more than two-thirds of the esophageal circumference.
Key exclusion criteria (4 listed)
- Severe circulatory or respiratory disease，severe renal impairment
- Women in pregnancy and lactation
- Patients with steroid contraindications
- Patients refuse to join in this study
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 |
|---|---|---|
| combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）local steroid injection and oral steroid | Drug | combination group |
| oral steroid administration（prednisone）oral steroid | Drug | control group |
Primary outcome
the stricture rate
Time frame: 12weeks
the incidence of esophageal rate after ESD
the time when stricture occurs
Time frame: 12weeks
2 secondary outcomes
the frequency of dilatation sessions required
Time frame: 12 months
the frequency of complications
Time frame: 12 months
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 4 Sep 2019.
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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.
Meidong Xu, PhD principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） and oral steroid administration（prednisone） in people with Esophageal Stricture, run by Shanghai Zhongshan Hospital at 1 site in China.
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 3 inclusion and 4 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 4 Sep 2019. 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 China. 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?
the stricture rate (time frame: 12weeks). 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 4 Sep 2019.