Esophageal NeoplasmsPhase 4NCT05768282
Oral Prednisolone to Prevent Esophageal Stricture After RFA for Long-segment Esophageal Neoplasia
A Phase 4 study testing Oral prednisolone (30mg/day) for 28 days in people with Esophageal Neoplasms and Esophagus Stenosis, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
Endoscopic radiofrequency ablation (RFA) has shown good efficacy and safety in eradicating flat-type early esophageal squamous cell neoplasia (ESCN). However, post-RFA stricture is still a major concern, especially when treating long-segment early ESCNs. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Neoplasms, Esophagus Stenosis
- What is being tested?
- Oral prednisolone (30mg/day) for 28 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2016to 31 Dec 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histology from endoscopic biopsies showed squamous intraepithelial neoplasia without stromal invasion;
- No lymph node metastasis on endoscopic ultrasound or computed tomography;
- Magnifying endoscopy showed the intraepithelial papillary capillary loop as type B1 pattern, according to the classification of the microvascular architecture of superficial esophageal carcinoma.
Who cannot join
- A prior history of endoscopic resection, radiation therapy or esophagectomy for esophageal cancer;
- A stricture that prevented the passage of a therapeutic endoscope;
- Uncontrolled coagulopathy;
- Poorly controlled diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
EDA Hospital
Kaohsiung City, 82445
Wen-Lun Wang, Ph.D, 886-7-6150011 ext. 251346, warrengodr@gmail.com
About this study
Official title: Administration of Oral Prednisolone to Prevent Esophageal Stricture After Balloon-type Radiofrequency Ablation for Long-segment Esophageal Neoplasia
Endoscopic radiofrequency ablation (RFA) has shown good efficacy and safety in eradicating flat-type early esophageal squamous cell neoplasia (ESCN). However, post-RFA stricture is still a major concern, especially when treating long-segment early ESCNs. The aim of this study was to investigate the efficacy and safety of oral prednisolone to prevent post-RFA stricture.
Read the detailed description
Esophageal cancer is the eighth most common cancer and the sixth most common cause of cancer death worldwide. The incidence rates of esophageal squamous cancers are still increasing in some countries in the Asia-Pacific region and Africa. Recently, image-enhanced endoscopy techniques such as Lugol or virtual chromoendoscopy have been shown to improve the detection and diagnosis of early esophageal squamous cell neoplasia (ESCN). However, some ESCNs spread laterally and present as long-segment lesions or appear with a mosaic pattern, all of which increase the difficulties and adverse event rates if treated by endoscopic resection. In particular, for extensive ESCNs, endoscopic submucosal dissection (ESD) has been associated with severe refractory stricture, even after pre-emptive steroid administration. This then requires repeated sessions of balloon dilation, leading to a decreased quality of life and increased medical expenses.
Radiofrequency ablation (RFA) has rapidly evolved in recent decades, and previous studies have shown its efficacy and safety in treating early ESCNs. Current evidence has shown that RFA is indicated for totally flat-type precancerous lesions, such as high-grade intraepithelial neoplasia (HGIN) or moderate-grade intraepithelial neoplasia (MGIN), or those that are not feasible for ESD. RFA is less technically demanding and more feasible for widely extended lesions. However, post-RFA esophageal stricture is still a concern, with an average frequency of 14~28%. The longitudinal length of the treatment area is the key factor associated with post-operative stricture. Around 50% of cases where the lesion is extended by more than 9 cm will develop post-RFA esophageal stricture, and thus a preventive strategy is urgently needed. The investigators previously evaluated the in vivo tissue effect of RFA by endoscopic ultrasound, and the results showed that the mucosa and submucosal layer were more edematous and thicker after RFA than before the procedure, suggesting that the thermal effect of RFA may injure the submucosa resulting in inflammation-related fibrosis and stricture. Steroids have an anti-inflammatory effect, and previous studies have shown that steroid treatment could potentially reduce post-ESD stricture in lesions occupying more than three-quarters of the circumference. However, the effectiveness of steroid treatment in preventing post-RFA stricture has yet to be elucidated. Therefore, the aim of this study is to investigate the effectiveness and safety of oral prednisolone treatment in preventing post-RFA esophageal stricture in long-segment and extensive ESCNs.
- Conditions
- Esophageal Neoplasms, Esophagus Stenosis
- Being tested
- Oral prednisolone (30mg/day) for 28 days
- Keywords
- Esophageal stenosis, Esophageal squamous cell neoplasia, Endoscopic radiofrequency ablation, Prednisolone
- Medical subject headings
- Esophageal Neoplasms, Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral prednisolone (30mg/day) for 28 daysDrug
Also called steroid
Oral prednisolone was started at a dose of 30 mg/day on the third day after RFA, and continued for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Administration of oral prednisolone | Experimental | Oral prednisolone start at a dose of 30 mg/day on the third day after RFA, and continue for 4 weeks. Receives: Drug: Oral prednisolone (30mg/day) for 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with esophageal stenosis after RFA
Defined as the failure of a standard endoscope (9.8 mm in diameter) to pass through the stenosis.Then the outcome measures will be compared with a historical control, that just received endoscopic surveillance.
Measured: at 1 month after the RFA procedure
Secondary outcomes (2)
The number of endoscopic balloon dilatation sessions required
f the esophageal stenosis was confirmed by endoscopy, balloon dilation will be done to resolve the symptoms
Measured: at 1 month after the RFA procedure
The adverse events rate
After oral prednisolone, the adverse events will be recorded.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Jan 2016
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768282
- Sponsor's protocol ID
- EDAHS111018
- Status last verified
- Mar 2023
- First submitted
- 10 Oct 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ono S, Fujishiro M, Niimi K, Goto O, Kodashima S, Yamamichi N, Omata M. Predictors of postoperative stricture after esophageal endoscopic submucosal dissection for superficial squamous cell neoplasms. Endoscopy. 2009 Aug;41(8):661-5. doi: 10.1055/s-0029-1214867. Epub 2009 Jun 29.
PubMed 19565442Yamaguchi N, Isomoto H, Nakayama T, Hayashi T, Nishiyama H, Ohnita K, Takeshima F, Shikuwa S, Kohno S, Nakao K. Usefulness of oral prednisolone in the treatment of esophageal stricture after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma. Gastrointest Endosc. 2011 Jun;73(6):1115-21. doi: 10.1016/j.gie.2011.02.005. Epub 2011 Apr 14.
PubMed 21492854Wang WL, Chang IW, Chen CC, Chang CY, Tseng CH, Tai CM, Lin JT, Wang HP, Lee CT. Lessons from pathological analysis of recurrent early esophageal squamous cell neoplasia after complete endoscopic radiofrequency ablation. Endoscopy. 2018 Aug;50(8):743-750. doi: 10.1055/s-0044-101352. Epub 2018 Feb 15.
PubMed 29448289Wang WL, Chang IW, Chen CC, Chang WL, Chu YY, Wu PH, Tai WC, Chen PY, Hsieh PH, Chung CS, Chang CY, Lin JT, Wang HP, Lee CT. Predictors for postoperative esophageal stricture after balloon-based radiofrequency ablation for early esophageal squamous neoplasia: a multicenter validation study. Ther Adv Gastroenterol. 2016 May;9(3):257-64. doi: 10.1177/1756283X16633051. Epub 2016 Feb 25.
PubMed 27134656Wang WL, Tsai YN, Hsu MH, Lin JT, Wang HP, Lee CT. Administration of oral prednisolone to prevent esophageal stricture after balloon-type radiofrequency ablation for ultralong-segment esophageal neoplasia. Gastrointest Endosc. 2024 Aug;100(2):192-199. doi: 10.1016/j.gie.2024.03.030. Epub 2024 Apr 5.
PubMed 38583540
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Oral Prednisolone to Prevent Esophageal Stricture After Balloon-type Radiofrequency Ablation for Long-segment Esophageal Neoplasia
- ClinicalTrials.gov ID
- NCT05768282
- Acronym / sponsor ID
- EDAHS111018
- Conditions
- Esophageal Neoplasms, Esophagus Stenosis
- Keywords
- Esophageal stenosis, Esophageal squamous cell neoplasia, Endoscopic radiofrequency ablation, Prednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Mar 2023 (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 radiofrequency ablation (RFA) has shown good efficacy and safety in eradicating flat-type early esophageal squamous cell neoplasia (ESCN). However, post-RFA stricture is still a major concern, especially when treating long-segment early ESCNs. The aim of this study was to investigate the efficacy and safety of oral prednisolone to prevent post-RFA stricture.
Detailed description
Esophageal cancer is the eighth most common cancer and the sixth most common cause of cancer death worldwide. The incidence rates of esophageal squamous cancers are still increasing in some countries in the Asia-Pacific region and Africa. Recently, image-enhanced endoscopy techniques such as Lugol or virtual chromoendoscopy have been shown to improve the detection and diagnosis of early esophageal squamous cell neoplasia (ESCN). However, some ESCNs spread laterally and present as long-segment lesions or appear with a mosaic pattern, all of which increase the difficulties and adverse event rates if treated by endoscopic resection. In particular, for extensive ESCNs, endoscopic submucosal dissection (ESD) has been associated with severe refractory stricture, even after pre-emptive steroid administration. This then requires repeated sessions of balloon dilation, leading to a decreased quality of life and increased medical expenses.
Radiofrequency ablation (RFA) has rapidly evolved in recent decades, and previous studies have shown its efficacy and safety in treating early ESCNs. Current evidence has shown that RFA is indicated for totally flat-type precancerous lesions, such as high-grade intraepithelial neoplasia (HGIN) or moderate-grade intraepithelial neoplasia (MGIN), or those that are not feasible for ESD. RFA is less technically demanding and more feasible for widely extended lesions. However, post-RFA esophageal stricture is still a concern, with an average frequency of 14~28%. The longitudinal length of the treatment area is the key factor associated with post-operative stricture. Around 50% of cases where the lesion is extended by more than 9 cm will develop post-RFA esophageal stricture, and thus a preventive strategy is urgently needed. The investigators previously evaluated the in vivo tissue effect of RFA by endoscopic ultrasound, and the results showed that the mucosa and submucosal layer were more edematous and thicker after RFA than before the procedure, suggesting that the thermal effect of RFA may injure the submucosa resulting in inflammation-related fibrosis and stricture. Steroids have an anti-inflammatory effect, and previous studies have shown that steroid treatment could potentially reduce post-ESD stricture in lesions occupying more than three-quarters of the circumference. However, the effectiveness of steroid treatment in preventing post-RFA stricture has yet to be elucidated. Therefore, the aim of this study is to investigate the effectiveness and safety of oral prednisolone treatment in preventing post-RFA esophageal stricture in long-segment and extensive ESCNs.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of oral prednisolone | Experimental | Drug: Oral prednisolone (30mg/day) for 28 daysOral prednisolone start at a dose of 30 mg/day on the third day after RFA, and continue for 4 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histology from endoscopic biopsies showed squamous intraepithelial neoplasia without stromal invasion;
- No lymph node metastasis on endoscopic ultrasound or computed tomography;
- Magnifying endoscopy showed the intraepithelial papillary capillary loop as type B1 pattern, according to the classification of the microvascular architecture of superficial esophageal carcinoma.
Key exclusion criteria (4 listed)
- A prior history of endoscopic resection, radiation therapy or esophagectomy for esophageal cancer;
- A stricture that prevented the passage of a therapeutic endoscope;
- Uncontrolled coagulopathy;
- Poorly controlled diabetes mellitus.
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 |
|---|---|---|
| Oral prednisolone (30mg/day) for 28 daysAlso: steroidOral prednisolone was started at a dose of 30 mg/day on the third day after RFA, and continued for 4 weeks. | Drug | Administration of oral prednisolone |
Primary outcome
The proportion of patients with esophageal stenosis after RFA
Time frame: at 1 month after the RFA procedure
Defined as the failure of a standard endoscope (9.8 mm in diameter) to pass through the stenosis.Then the outcome measures will be compared with a historical control, that just received endoscopic surveillance.
2 secondary outcomes
The number of endoscopic balloon dilatation sessions required
Time frame: at 1 month after the RFA procedure
The adverse events rate
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 19565442Ono S, Fujishiro M, Niimi K, Goto O, Kodashima S, Yamamichi N, Omata M. Predictors of postoperative stricture after esophageal endoscopic submucosal dissection for superficial squamous cell neoplasms. Endoscopy. 2009 Aug;41(8):661-5. doi: 10.1055/s-0029-1214867. Epub 2009 Jun 29.
- Background: PubMed 21492854Yamaguchi N, Isomoto H, Nakayama T, Hayashi T, Nishiyama H, Ohnita K, Takeshima F, Shikuwa S, Kohno S, Nakao K. Usefulness of oral prednisolone in the treatment of esophageal stricture after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma. Gastrointest Endosc. 2011 Jun;73(6):1115-21. doi: 10.1016/j.gie.2011.02.005. Epub 2011 Apr 14.
- Background: PubMed 29448289Wang WL, Chang IW, Chen CC, Chang CY, Tseng CH, Tai CM, Lin JT, Wang HP, Lee CT. Lessons from pathological analysis of recurrent early esophageal squamous cell neoplasia after complete endoscopic radiofrequency ablation. Endoscopy. 2018 Aug;50(8):743-750. doi: 10.1055/s-0044-101352. Epub 2018 Feb 15.
- Background: PubMed 27134656Wang WL, Chang IW, Chen CC, Chang WL, Chu YY, Wu PH, Tai WC, Chen PY, Hsieh PH, Chung CS, Chang CY, Lin JT, Wang HP, Lee CT. Predictors for postoperative esophageal stricture after balloon-based radiofrequency ablation for early esophageal squamous neoplasia: a multicenter validation study. Ther Adv Gastroenterol. 2016 May;9(3):257-64. doi: 10.1177/1756283X16633051. Epub 2016 Feb 25.
- Derived from this study: PubMed 38583540Wang WL, Tsai YN, Hsu MH, Lin JT, Wang HP, Lee CT. Administration of oral prednisolone to prevent esophageal stricture after balloon-type radiofrequency ablation for ultralong-segment esophageal neoplasia. Gastrointest Endosc. 2024 Aug;100(2):192-199. doi: 10.1016/j.gie.2024.03.030. Epub 2024 Apr 5.
- 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.
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 Oral prednisolone (30mg/day) for 28 days in people with Esophageal Neoplasms and Esophagus Stenosis, run by E-DA Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Lun Wang, Ph.D (+886918464373, warrengodr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with esophageal stenosis after RFA (time frame: at 1 month after the RFA procedure). 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 NCT05768282, which also lists 5 linked publications.
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 16 Mar 2023.