Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia

NCT02047305 | Completed Results DMC

• 1 other identifier: B300
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.

Conditions

ESOPHAGEAL SQUAMOUS CELL CARCINOMA

Keywords

ESCN; RFA

Outcome Measures

Primary Outcomes (1)

• Complete Response

  The percentage of subjects demonstrating complete response (CR) defined as complete histological clearance of MGIN, HGIN and SCCA in the treatment area at 12 months after the initial ablation procedure

  12 Month

Study Arms (1)

Radiofrequency ablation

EXPERIMENTAL

To study the safety and effectiveness of radiofrequency ablation (RFA) using the HALO ablation system in completely eradicating the diseased epithelium in patients with ESCN

Device: Radiofrequency Ablation

Interventions

Radiofrequency Ablation DEVICE

Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.

Also known as: RFA, Barrx ablation system, HALO ablation system

Radiofrequency ablation

Eligibility Criteria

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

You may qualify if:

• Subject is 18-80 years of age, inclusive
• Within the last 3 months, subject demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus, or...
• within the last 3 months, subject demonstrated a new diagnosis of a flat-type (type 0-IIb) SCCA (G1/G2 only)
• On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and has MGIN or worse (MGIN+) on biopsy
• The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
• Subject is not pregnant nor has plans to become pregnant in the ensuing 12 months (confirmation of non-pregnant status in women of child-bearing age and ability required with urine or blood test)
• Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol
• The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation

You may not qualify if:

• the Eligibility CRF.
• Esophageal stricture preventing passage of a therapeutic endoscope
• Any prior endoscopic resection
• Any esophageal dilation in the past 12 months
• Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage) prior to 3 months before screening for this trial
• Any N or M positive status, if patient has a present diagnosis of esophageal SCCA
• Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) or any radiation therapy to the esophagus.
• Any previous esophageal surgery, except fundoplication without complications (i.e. no slippage, dysphagia, etc)
• Evidence of esophageal varices detected within last 6 months or at initial RFA procedure
• Evidence of eosinophilic esophagitis on endoscopy and/or histology
• Report of uncontrolled coagulopathy with international normalized ratio (INR) \> 2 or platelet count \<75,000 platelets per µL (note: a complete blood count is not required for all subjects in this study)
• Subject is using aspirin, clopidogrel, or non-steroidal anti-inflammatory drugs that can not be discontinued 7 days before and after therapeutic sessions
• Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
• Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
• Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol

Sponsors & Collaborators

• Covidien, GI Solutions: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (3)

• 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. Endoscopy. 2015 May;47(5):398-408. doi: 10.1055/s-0034-1391285. Epub 2015 Feb 10.

  PMID: 25668428 RESULT

• 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. doi: 10.1016/j.gie.2011.05.024. Epub 2011 Aug 15.

  PMID: 21839994 RESULT

• Yu X, van Munster SN, Zhang Y, Xue L, Fleischer DE, Weusten BLAM, Lu N, Dawsey SSM, Bergman JJGHM, Wang G. Durability of radiofrequency ablation for treatment of esophageal squamous cell neoplasia: 5-year follow-up of a treated cohort in China. Gastrointest Endosc. 2019 Apr;89(4):736-748.e2. doi: 10.1016/j.gie.2018.10.030. Epub 2018 Oct 26.

  PMID: 30905354 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Senior Director of Clinical Affairs
• Organization: Medtronic MITG-RGI

Tumordirectedtherapiesclinical@Medtronic.com

303-581-7064

Study Officials

• Guiqi Wang, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: January 1, 2009
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 21, 2020
• Results First Posted: May 21, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)