Esophageal StenosisPhase 4NCT04498260
Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture
A Phase 4 study testing Local steroid - triamcinolone acetonide and Oral steroid - predonisolone in people with Esophageal Stenosis, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Endoscopic resection of superficial esophageal neoplasms is already a reality and presents important advantages when compared to esophagectomy as fewer complications and better quality of life. However, extensive resections can lead to difficult-to-manage stenoses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Stenosis
- What is being tested?
- Local steroid - triamcinolone acetonide and Oral steroid - predonisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jan 2019to 31 May 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of superficial esophageal neoplasm submitted to submucosal endoscopic resection greater than 3/4 of the organ circumference;
- Absence of lymph node or distant metastases, evaluated through echoendoscopy, CT and PET-CT;
- Signed informed consent form
Who cannot join
- Presence of invasive esophageal neoplasia
- Hepatical cirrhosis
- Diabetes mellitus with fasting glycemia above 200mg%
- Use of corticosteroids in the 30 days prior to ESD
- INR> 1.5
- Platelet count less than 50,000
Show all 10Show fewer
- Active gastrointestinal ulcer
- Severe psychiatric illness
- Glaucoma
- History of allergy or hypersensitivity to corticosteroids or proton pump inhibitor
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, 01246-000
About this study
Official title: Prospective, Randomized Trial of Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture After Endoscopic Submucosal Dissection
Endoscopic resection of superficial esophageal neoplasms is already a reality and presents important advantages when compared to esophagectomy as fewer complications and better quality of life. However, extensive resections can lead to difficult-to-manage stenoses. There are several therapies available in order to prevent this stenosis but, to date, there is no definition of the gold standard.
The objective of this study was to compare the use of intralesional steroid injection versus oral prednisolone after endoscopic submucosal dissection and to evaluate the stenosis rate, number of dilations to resolve the stenosis and complications.
Read the detailed description
Endoscopic resection of superficial esophageal neoplasms is widely used as an alternative to esophagectomy, since it is less invasive, besides presenting good clinical results. Compared with esophagectomy, patients submitted to endoscopic resection present shorter hospitalization time, lower incidence of complications and better quality of life in the long term.
However, repair of esophageal ulcer, caused by endoscopic resection, which occupies three quarters or more of the circumference of the organ, can result in the formation of stenosis.
In the past, there was no consensus on the use of preventive therapies for esophageal stenosis after extensive ESD. However, Oliveira et al recently demonstrated through systematic review and meta-analysis that the use of these therapies reduces the rate of stenosis (40% on average), decreased the number of dilations to resolve the stenosis (8 sessions less ), Without altering the number of complications.
Theoretically, corticosteroids are the most appropriate choice due to their mechanism of action, modulating wound healing by preventing inflammation, by reducing prolyl hydroxylase, which helps reduce collagen production.
However, treatment with corticosteroids, especially at high oral doses, can cause several adverse effects, such as immunosuppression, diabetes, psychiatric disorders, osteoporosis, optic lesion and peptic ulcer. Thus, the use of local corticosteroid injection could minimize these side effects. However, local injection implies risks of bleeding and perforation, and is of limited use in patients receiving anticoagulant or antiplatelet therapy.
The objective of this study was to compare the local corticosteroid injection and the use of oral corticosteroids to prevent stenosis after extensive submucosal endoscopic resection of superficial esophageal carcinoma, in relation to the stenosis rate, number of dilations necessary to resolve the stenosis and frequency of complications.
- Conditions
- Esophageal Stenosis
- Being tested
- Local steroid - triamcinolone acetonide, Oral steroid - predonisolone
- Keywords
- endoscopy submucosal dissection, ESD, esophageal stenosis, esophageal stricture, steroid injection, oral prednisolone
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local steroid - triamcinolone acetonideDrug
(triamcinolone acetonide)
Oral steroid - predonisoloneDrug
(predonisolone)
| Study group | Role | What they receive |
|---|---|---|
| Local steroid-triamcinolone acetonide | Experimental | Local steroid (triamcinolone acetonide) injection to the ulcer immediately after ESD. Total amount of injected triamcinolone is 100 mg. Receives: Drug: Local steroid - triamcinolone acetonide |
| Oral steroid-predonisolone | Active comparator | (predonisolone) administration three days after ESD. Predonisolone is administered over 8 weeks, started at 30 mg/day and tapered 30, 30, 25, 25, 20, 15, 10 and 5 every 7 days, totaling 8 weeks of treatment. Receives: Drug: Oral steroid - predonisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Stenosis rate
Stenosis to the passage of the standard endoscopic (9.8 mm)
Measured: 12 weeks
Late Stenosis rate
Stenosis to the passage of the standard endoscopic (9.8 mm)
Measured: 24 weeks
Early resistance rate
Resistance to the passage of the standard endoscopic (9.8 mm)
Measured: 12 weeks
Late resistance rate
Resistance to the passage of the standard endoscopic (9.8 mm)
Measured: 24 weeks
Secondary outcomes (1)
Number of dilations to solve the stenosis
Number of endoscopic dilations (Savary or balloon)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start21 Jan 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal StenosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498260
- Sponsor's protocol ID
- NP888/2016
- Status last verified
- Jul 2026
- First submitted
- 30 Jan 2019
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Oliveira JF, Martins BC, Moura RN, de Paulo GA, Lenz L, de Lima MS, Safatle-Ribeiro AV, Maluf-Filho F. Randomized trial of intralesional steroid injection versus oral prednisolone for preventing esophageal stricture after extensive endoscopic submucosal dissection. Dis Esophagus. 2026 Mar 2;39(2):doag027. doi: 10.1093/dote/doag027.
PubMed 41926323
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture After Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT04498260
- Acronym / sponsor ID
- NP888/2016
- Conditions
- Esophageal Stenosis
- Keywords
- endoscopy submucosal dissection, ESD, esophageal stenosis, esophageal stricture, steroid injection, oral prednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 4 Aug 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.
Endoscopic resection of superficial esophageal neoplasms is already a reality and presents important advantages when compared to esophagectomy as fewer complications and better quality of life. However, extensive resections can lead to difficult-to-manage stenoses. There are several therapies available in order to prevent this stenosis but, to date, there is no definition of the gold standard.
The objective of this study was to compare the use of intralesional steroid injection versus oral prednisolone after endoscopic submucosal dissection and to evaluate the stenosis rate, number of dilations to resolve the stenosis and complications.
Detailed description
Endoscopic resection of superficial esophageal neoplasms is widely used as an alternative to esophagectomy, since it is less invasive, besides presenting good clinical results. Compared with esophagectomy, patients submitted to endoscopic resection present shorter hospitalization time, lower incidence of complications and better quality of life in the long term.
However, repair of esophageal ulcer, caused by endoscopic resection, which occupies three quarters or more of the circumference of the organ, can result in the formation of stenosis.
In the past, there was no consensus on the use of preventive therapies for esophageal stenosis after extensive ESD. However, Oliveira et al recently demonstrated through systematic review and meta-analysis that the use of these therapies reduces the rate of stenosis (40% on average), decreased the number of dilations to resolve the stenosis (8 sessions less ), Without altering the number of complications.
Theoretically, corticosteroids are the most appropriate choice due to their mechanism of action, modulating wound healing by preventing inflammation, by reducing prolyl hydroxylase, which helps reduce collagen production.
However, treatment with corticosteroids, especially at high oral doses, can cause several adverse effects, such as immunosuppression, diabetes, psychiatric disorders, osteoporosis, optic lesion and peptic ulcer. Thus, the use of local corticosteroid injection could minimize these side effects. However, local injection implies risks of bleeding and perforation, and is of limited use in patients receiving anticoagulant or antiplatelet therapy.
The objective of this study was to compare the local corticosteroid injection and the use of oral corticosteroids to prevent stenosis after extensive submucosal endoscopic resection of superficial esophageal carcinoma, in relation to the stenosis rate, number of dilations necessary to resolve the stenosis and frequency of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local steroid-triamcinolone acetonide | Experimental | Drug: Local steroid - triamcinolone acetonideLocal steroid (triamcinolone acetonide) injection to the ulcer immediately after ESD. Total amount of injected triamcinolone is 100 mg. |
| Oral steroid-predonisolone | Active comparator | Drug: Oral steroid - predonisolone(predonisolone) administration three days after ESD. Predonisolone is administered over 8 weeks, started at 30 mg/day and tapered 30, 30, 25, 25, 20, 15, 10 and 5 every 7 days, totaling 8 weeks of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of superficial esophageal neoplasm submitted to submucosal endoscopic resection greater than 3/4 of the organ circumference;
- Absence of lymph node or distant metastases, evaluated through echoendoscopy, CT and PET-CT;
- Signed informed consent form
Key exclusion criteria (10 listed)
- Presence of invasive esophageal neoplasia
- Hepatical cirrhosis
- Diabetes mellitus with fasting glycemia above 200mg%
- Use of corticosteroids in the 30 days prior to ESD
- INR> 1.5
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 |
|---|---|---|
| Local steroid - triamcinolone acetonide(triamcinolone acetonide) | Drug | Local steroid-triamcinolone acetonide |
| Oral steroid - predonisolone(predonisolone) | Drug | Oral steroid-predonisolone |
Primary outcome
Early Stenosis rate
Time frame: 12 weeks
Stenosis to the passage of the standard endoscopic (9.8 mm)
Late Stenosis rate
Time frame: 24 weeks
Stenosis to the passage of the standard endoscopic (9.8 mm)
Early resistance rate
Time frame: 12 weeks
Resistance to the passage of the standard endoscopic (9.8 mm)
Late resistance rate
Time frame: 24 weeks
Resistance to the passage of the standard endoscopic (9.8 mm)
1 secondary outcome
Number of dilations to solve the stenosis
Time frame: 24 weeks
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 24 Jul 2026.
- Derived from this study: PubMed 41926323de Oliveira JF, Martins BC, Moura RN, de Paulo GA, Lenz L, de Lima MS, Safatle-Ribeiro AV, Maluf-Filho F. Randomized trial of intralesional steroid injection versus oral prednisolone for preventing esophageal stricture after extensive endoscopic submucosal dissection. Dis Esophagus. 2026 Mar 2;39(2):doag027. doi: 10.1093/dote/doag027.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Local steroid - triamcinolone acetonide and Oral steroid - predonisolone in people with Esophageal Stenosis, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 10 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 24 Jul 2026. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Early Stenosis rate (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498260, which also lists 1 linked publication.
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 24 Jul 2026.