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Oral Prednisolone to Prevent Esophageal Stricture After RFA for Long-segment Esophageal Neoplasia

Primary Purpose

Esophageal Neoplasms, Esophagus Stenosis

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Oral prednisolone (30mg/day) for 28 days
Sponsored by
E-DA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Neoplasms focused on measuring Esophageal stenosis, Esophageal squamous cell neoplasia, Endoscopic radiofrequency ablation, Prednisolone

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • EDA HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of oral prednisolone

Arm Description

Oral prednisolone start at a dose of 30 mg/day on the third day after RFA, and continue for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
The adverse events rate
After oral prednisolone, the adverse events will be recorded.

Full Information

First Posted
October 10, 2022
Last Updated
March 14, 2023
Sponsor
E-DA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05768282
Brief Title
Oral Prednisolone to Prevent Esophageal Stricture After RFA for Long-segment Esophageal Neoplasia
Official Title
Administration of Oral Prednisolone to Prevent Esophageal Stricture After Balloon-type Radiofrequency Ablation for Long-segment Esophageal Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
E-DA Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Esophagus Stenosis
Keywords
Esophageal stenosis, Esophageal squamous cell neoplasia, Endoscopic radiofrequency ablation, Prednisolone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of oral prednisolone
Arm Type
Experimental
Arm Description
Oral prednisolone start at a dose of 30 mg/day on the third day after RFA, and continue for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Oral prednisolone (30mg/day) for 28 days
Other Intervention Name(s)
steroid
Intervention Description
Oral prednisolone was started at a dose of 30 mg/day on the third day after RFA, and continued for 4 weeks.
Primary Outcome Measure Information:
Title
The proportion of patients with esophageal stenosis after RFA
Description
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
Secondary Outcome Measure Information:
Title
The number of endoscopic balloon dilatation sessions required
Description
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
Title
The adverse events rate
Description
After oral prednisolone, the adverse events will be recorded.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Lun Wang, Ph.D
Phone
+886918464373
Email
warrengodr@gmail.com
Facility Information:
Facility Name
EDA Hospital
City
Kaohsiung City
ZIP/Postal Code
82445
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Lun Wang, Ph.D
Phone
886-7-6150011
Ext
251346
Email
warrengodr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19565442
Citation
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.
Results Reference
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PubMed Identifier
21492854
Citation
Yamaguchi 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.
Results Reference
background
PubMed Identifier
29448289
Citation
Wang 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.
Results Reference
background
PubMed Identifier
27134656
Citation
Wang 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. Therap Adv Gastroenterol. 2016 May;9(3):257-64. doi: 10.1177/1756283X16633051. Epub 2016 Feb 25.
Results Reference
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Oral Prednisolone to Prevent Esophageal Stricture After RFA for Long-segment Esophageal Neoplasia

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