A Phase 4 interventional study of Oral prednisolone (30mg/day) for 28 days in Esophageal Neoplasms and Esophagus Stenosis, sponsored by E-DA Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by E-DA Hospital · Phase 4, Interventional, and Prevention
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.
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.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's planned enrollment of 50 is below the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →E-DA Hospital is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral prednisolone start at a dose of 30 mg/day on the third day after RFA, and continue for 4 weeks.
Drug: Oral prednisolone (30mg/day) for 28 days
Drug page: Steroids
Oral prednisolone was started at a dose of 30 mg/day on the third day after RFA, and continued for 4 weeks.
Also known as: steroid
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.
Time frame: at 1 month after the RFA procedure
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
Time frame: at 1 month after the RFA procedure
The adverse events rate
After oral prednisolone, the adverse events will be recorded.
Time frame: up to 1 year
Plan to share: No
Started Jan 2016 (actual). Primary completion is estimated for Dec 2023, 95 months after the start.
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Studies of the drug tested here: Steroids
E-DA Hospital