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

NCT05768282 | Unknown Phase 4

• 1 other identifier: EDAHS111018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms; Esophagus Stenosis

Keywords

Esophageal stenosis; Esophageal squamous cell neoplasia; Endoscopic radiofrequency ablation; Prednisolone

Outcome Measures

Primary Outcomes (1)

• 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.

  at 1 month after the RFA procedure

Secondary Outcomes (2)

• The number of endoscopic balloon dilatation sessions required

  at 1 month after the RFA procedure

• The adverse events rate

  up to 1 year

Study Arms (1)

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.

Drug: Oral prednisolone (30mg/day) for 28 days

Interventions

Oral prednisolone (30mg/day) for 28 days DRUG

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

Administration of oral prednisolone

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (1)

EDA Hospital

Kaohsiung City, 82445, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 19565442 BACKGROUND

• 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.

  PMID: 21492854 BACKGROUND

• 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.

  PMID: 29448289 BACKGROUND

• 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.

  PMID: 27134656 BACKGROUND

• Wang 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.

  PMID: 38583540 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Stenosis

Interventions

Prednisolone; Steroids

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Wen-Lun Wang, Ph.D

CONTACT

+886918464373; warrengodr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: March 14, 2023
• Study Start: January 1, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)