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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03183115
Other study ID # ED102807
Secondary ID MOST105-2314-B-6
Status Recruiting
Phase N/A
First received
Last updated
Start date April 18, 2016
Est. completion date December 30, 2026

Study information

Verified date March 2023
Source E-DA Hospital
Contact Wen-Lun Wang, Ph.D
Phone 886-7-6150011
Email warrengodr@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Esophageal cancer is a highly lethal disease, and its incidence is still increasing in the world. Recent advances in image-enhanced techniques such as Lugol chromoendoscopy and narrow band imaging, the number of patients with early esophageal squamous cell neoplasias (ESCNs) detected has markedly increased. Endoscopic submucosal dissection (ESD) enables en bloc resection of the neoplasia, and the resected specimen allows for a pathological assessment to evaluate the curability. However, the patients who received complete ESD for early ESCNs frequently developed metachronous recurrence. The cumulative metachronous recurrence rate at 5 years was 50%, and the mean annual incidence of newly diagnosed metachronous tumors was 10%. Among them, those with "speckled" lugol staining pattern over the esophageal background mucosa have the highest risk and should be seen as a precancerous lesion of ESCCs. This issue is gaining attention in the era of endoscopic treatment, but currently there was no appropriate strategy to prevent the tumor recurrence in these high-risk subjects. Endoscopic radiofrequency ablation (RFA) is a rapidly evolving therapeutic modality, and recent studies have shown its efficacy and safety for eradicating for flat type early ESCNs. To search a best strategy for the prevention of ESCNs, the investigators thus propose a hypothesis that the preemptive RFA for esophageal "speckled" lugol background mucosa may prevent the metachronous neoplastic recurrence after complete endoscopic resection.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 30, 2026
Est. primary completion date October 30, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - Adults with early stage ESCNs (squamous high grade dysplasia, carcinoma in situ, or T1N0M0 SCC) who were treated by endoscopic submucosal dissection. - Lugol staining showed "speckled" (>10 small lugol-unstained lesions) pattern of background mucosa. Exclusion Criteria: - Having a history of incomplete endoscopic treatment, or complications during/after treatment (perforation, stricture). - Having history of systemic chemotherapy or radiation therapy for esophagus or post esophagectomy. - Life expectancy <2 yr. - Decompensated cirrhosis (Child score B, C). - Having large esophageal varices. - Poor performance status (ECOG>2).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Radiofrequency ablation
HALO360 System (Covidien GI Solutions, Sunnyvale, California, USA), which has been approved by the US Food and Drug Administration (FDA) and is approved for use in Europe (CE mark) and Taiwan (Ministry of Health and Welfare). Because the HALO 360 balloon catheter has been phased out since 2019, a new Barrxâ„¢ 360 Express catheter was used thereafter.
Device:
Endoscopy
The participants will receive meticulous endoscopic examination with Lugol chromoendoscopy and Narrow-band imaging
Drug:
Lugol's Solution (1.5%)
Before the RFA intervention, the participants will received Lugol staining over the esophagus

Locations

Country Name City State
Taiwan EDA Hospital Kaohsiung City

Sponsors (2)

Lead Sponsor Collaborator
E-DA Hospital National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

Bergman JJ, Zhang YM, He S, Weusten B, Xue L, Fleischer DE, Lu N, Dawsey SM, Wang GQ. Outcomes from a prospective trial of endoscopic radiofrequency ablation of early squamous cell neoplasia of the esophagus. Gastrointest Endosc. 2011 Dec;74(6):1181-90. d — View Citation

He S, Bergman J, Zhang Y, Weusten B, Xue L, Qin X, Dou L, Liu Y, Fleischer D, Lu N, Dawsey SM, Wang GQ. Endoscopic radiofrequency ablation for early esophageal squamous cell neoplasia: report of safety and effectiveness from a large prospective trial. End — View Citation

Lee CT, Chang CY, Lee YC, Tai CM, Wang WL, Tseng PH, Hwang JC, Hwang TZ, Wang CC, Lin JT. Narrow-band imaging with magnifying endoscopy for the screening of esophageal cancer in patients with primary head and neck cancers. Endoscopy. 2010 Aug;42(8):613-9. — View Citation

Lee CT, Chang CY, Tai CM, Wang WL, Tseng CH, Hwang JC, Lin JT. Endoscopic submucosal dissection for early esophageal neoplasia: a single center experience in South Taiwan. J Formos Med Assoc. 2012 Mar;111(3):132-9. doi: 10.1016/j.jfma.2010.12.002. Epub 20 — View Citation

Muto M, Hironaka S, Nakane M, Boku N, Ohtsu A, Yoshida S. Association of multiple Lugol-voiding lesions with synchronous and metachronous esophageal squamous cell carcinoma in patients with head and neck cancer. Gastrointest Endosc. 2002 Oct;56(4):517-21. — View Citation

Phoa KN, van Vilsteren FG, Weusten BL, Bisschops R, Schoon EJ, Ragunath K, Fullarton G, Di Pietro M, Ravi N, Visser M, Offerhaus GJ, Seldenrijk CA, Meijer SL, ten Kate FJ, Tijssen JG, Bergman JJ. Radiofrequency ablation vs endoscopic surveillance for pati — View Citation

Shaheen NJ, Overholt BF, Sampliner RE, Wolfsen HC, Wang KK, Fleischer DE, Sharma VK, Eisen GM, Fennerty MB, Hunter JG, Bronner MP, Goldblum JR, Bennett AE, Mashimo H, Rothstein RI, Gordon SR, Edmundowicz SA, Madanick RD, Peery AF, Muthusamy VR, Chang KJ, — View Citation

Shaheen NJ, Sharma P, Overholt BF, Wolfsen HC, Sampliner RE, Wang KK, Galanko JA, Bronner MP, Goldblum JR, Bennett AE, Jobe BA, Eisen GM, Fennerty MB, Hunter JG, Fleischer DE, Sharma VK, Hawes RH, Hoffman BJ, Rothstein RI, Gordon SR, Mashimo H, Chang KJ, — View Citation

Shimizu Y, Tukagoshi H, Fujita M, Hosokawa M, Kato M, Asaka M. Metachronous squamous cell carcinoma of the esophagus arising after endoscopic mucosal resection. Gastrointest Endosc. 2001 Aug;54(2):190-4. doi: 10.1067/mge.2001.116877. — View Citation

Urabe Y, Hiyama T, Tanaka S, Oka S, Yoshihara M, Arihiro K, Chayama K. Metachronous multiple esophageal squamous cell carcinomas and Lugol-voiding lesions after endoscopic mucosal resection. Endoscopy. 2009 Apr;41(4):304-9. doi: 10.1055/s-0029-1214477. Ep — View Citation

van Vilsteren FG, Alvarez Herrero L, Pouw RE, ten Kate FJ, Visser M, Seldenrijk CA, van Berge Henegouwen MI, Weusten BL, Bergman JJ. Radiofrequency ablation for the endoscopic eradication of esophageal squamous high grade intraepithelial neoplasia and muc — View Citation

Wang WL, Chang IW, Chang CY, Lin JT, Mo LR, Wang HP, Lee CT. Circumferential balloon-based radiofrequency ablation for ultralong and extensive flat esophageal squamous neoplasia. Gastrointest Endosc. 2014 Dec;80(6):1185-9. doi: 10.1016/j.gie.2014.07.025. — View Citation

Wang WL, Chang IW, Chen CC, Chang CY, Mo LR, Lin JT, Wang HP, Lee CT. Radiofrequency Ablation Versus Endoscopic Submucosal Dissection in Treating Large Early Esophageal Squamous Cell Neoplasia. Medicine (Baltimore). 2015 Dec;94(49):e2240. doi: 10.1097/MD. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor recurrence Metachronous tumor recurrence is defined as a tumor (high-grade dysplasia or squamous cell carcinoma) recurring at a new site after more than 6 months of complete remission status. From date of randomization until the date of first documented tumor recurrence, assessed up to 100 months
Secondary Major adverse events including perforation, dysphagia, stenosis, defined as the failure of a standard endoscope (9.8 mm in diameter) to pass through the stenosis, or others resulting in the patients intolerable and discontinued intervention. From date of intervention until the date of first documented adverse events, assessed up to 12months