RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection

March 2, 2023 updated by: E-DA Hospital

Preemptive Radiofrequency Ablation for Esophageal Speckled Lugol Background Mucosa to Prevent Metachronous Neoplastic Recurrence After Complete Endoscopic Submucosal Dissection ~A Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ching-Tai Lee, M.D.
  • Phone Number: 251205 886-7-6150011
  • Email: fattoo@gmail.com

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • Recruiting
        • EDA Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA group

Balloon type RFA (12J/cm2, 1 application) will be applied for the entire speckled esophageal mucosa at the 3 months after complete ESD.

Oral prednisolone 30mg/day will be prescribed at day 3 after RFA procedure and continue for 28 days to prevent the post-RFA stenosis.
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 Barrx™ 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
No Intervention: Control group
No intervention; surveillance endoscopy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor recurrence
Time Frame: From date of randomization until the date of first documented tumor recurrence, assessed up to 100 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse events
Time Frame: From date of intervention until the date of first documented adverse events, assessed up to 12months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

E-DA Hospital

Collaborators

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2016

Primary Completion (Anticipated)

October 30, 2025

Study Completion (Anticipated)

December 30, 2026

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED102807
  • MOST105-2314-B-650-005 (Other Grant/Funding Number: Ministry of Science and Technology, Taiwan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The initial outcome and the data of adverse events will be shared with other researchers, by mail, when they are available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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