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Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus (ERADICATE)

Primary Purpose

Barrett's Esophagus, Esophageal Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency Ablation(RFA) by HALO device.
Endoscopic mucosal resection(EMR) by mucosectomy kit.
Sponsored by
Midwest Biomedical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barrett's Esophagus focused on measuring Barrett's Esophagus, Esophageal neoplasms, Radiofrequency ablation, Endoscopic mucosal resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects shall be screened according to the following inclusion criteria. An answer of "no" to any inclusion criterion disqualifies a subject from participating in this study.

  • Patients age: > 18 years
  • Subject has documented diagnosis of Barrett's esophagus, maximum endoscopic length of no more than C2M5 (i.e. no more than 2cm of circumferential extent and no more than 5cm of tongues) containing HGD/EC as follows:
  • HGD or EC documented on biopsy within previous 6 months from enrollment
  • Histology slides reviewed at central pathology service for ERADICATE Trial confirm HGD/EC.
  • Endoscopically visible lesion/area/pattern in a patient with HGD/EC either by high definition white light endoscopy, narrow band imaging, confocal laser endomicroscopy, or another enhanced imaging tool.
  • Ability to take oral proton pump inhibitor
  • For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter
  • Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan
  • Ability to discontinue aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation procedures
  • Ability of provide written, informed consent and understands the responsibilities of trial participation NOTE: At the Kansas City Veterans Hospital, participants must be eligible for care at the VA in order to be enrolled. Other sites listed are able to enroll non-veterans.

Exclusion Criteria:

Subjects shall be screened according to the following exclusion criteria. An answer of "yes" to any exclusion criterion disqualifies a subject from participating in this study.

  • Extent of BE >C2M5
  • The subject is pregnant or planning a pregnancy during the study period (12 months after treatment)
  • Esophageal stricture preventing passage of endoscope or catheter
  • Active erosive esophagitis
  • History of malignancy of the esophagus, esophageal varices or coagulopathy
  • Prior radiation therapy to the esophagus, except head and neck region radiation therapy.
  • Any previous ablation therapy within the esophagus (photodynamic therapy, multipolar electrocoagulation, argon plasma coagulation, laser treatment, or other)
  • Any previous EMR in the esophagus
  • Any previous esophageal surgery, including fundoplication
  • Evidence of esophageal varices during treatment endoscopy
  • Subject has a life-expectancy of less than two years due to an underlying medical condition
  • 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: Implantable cardiac defibrillator, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
  • The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the ERADICATE trial.
  • Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol

Sites / Locations

  • University Of Chicago
  • Barnes-Jewish Hospital
  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RFA arm

EMR arm

Arm Description

Under this arm, study patients will undergo radiofrequency ablation.

Under this arm, the individuals will undergo endoscopic mucosal resection.

Outcomes

Primary Outcome Measures

Complete histological eradication of Barrett's esophagus

Secondary Outcome Measures

Complete histological clearance of dysplasia
Complication rates

Full Information

First Posted
April 4, 2012
Last Updated
May 24, 2017
Sponsor
Midwest Biomedical Research Foundation
Collaborators
American Society for Gastrointestinal Endoscopy, Cook Group Incorporated, Washington University School of Medicine, Columbia University, University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01572987
Brief Title
Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
Acronym
ERADICATE
Official Title
Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment goals not being met
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Midwest Biomedical Research Foundation
Collaborators
American Society for Gastrointestinal Endoscopy, Cook Group Incorporated, Washington University School of Medicine, Columbia University, University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial will evaluate a patient population with Barrett's esophagus(BE) containing high grade dysplasia or intramucosal cancer and compare the effects of endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise endoscopic mucosal resection(S-EMR).
Detailed Description
This is a multi-center prospective, randomized controlled trial conducted at 4 centers. The patients with high grade dysplasia(HGD) and/or esophageal cancer(EC) who meet the study criteria will be enrolled, undergo a baseline diagnostic EMR and then be randomized in a 1:1 ratio to undergo treatment by either S-EMR or radiofrequency ablation(RFA). The initial staging EMR will not extend more than 50% of the esophageal circumference or more than 2 cm in longitudinal extent. Patients in the S-EMR group will undergo step-wise eradication of the BE segment using the Duette multi-band mucosectomy kit (Cook Medical, FDA approved) whereas those in the RFA group will undergo BE ablation using the endoscopically-guided HALO radiofrequency ablation system (Barrx Medical, FDA approved). Both treatment groups will undergo their respective treatment sessions every 2 months until either no Barrett's esophagus is seen or until a maximum of 4 treatment sessions. Once there is no visible Barrett's esophagus, patients will undergo surveillance biopsies (random 4 quadrant biopsies every 1 cm of the neo-squamous mucosa and random biopsies of the cardia) to evaluate for complete eradication of Barrett's esophagus. Regardless of whether there is visible Barrett's esophagus, all patients will undergo repeat endoscopy every 2 months for 1 year after enrollment. If no visible Barrett's esophagus is seen during the endoscopy, then surveillance biopsies to evaluate for dysplasia will be taken. Regardless of whether this is any visible Barrett's esophagus, all patients will undergo surveillance biopsies at 12 months after enrollment. The objective of this study is to compare the proportion of patients with complete eradication of Barrett's esophagus using S-EMR versus RFA at 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus, Esophageal Neoplasms
Keywords
Barrett's Esophagus, Esophageal neoplasms, Radiofrequency ablation, Endoscopic mucosal resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RFA arm
Arm Type
Active Comparator
Arm Description
Under this arm, study patients will undergo radiofrequency ablation.
Arm Title
EMR arm
Arm Type
Active Comparator
Arm Description
Under this arm, the individuals will undergo endoscopic mucosal resection.
Intervention Type
Device
Intervention Name(s)
Radiofrequency Ablation(RFA) by HALO device.
Other Intervention Name(s)
HALO Ablation Technology(BÂRRX Medical, Inc).
Intervention Description
RFA or Surveillance every 2 months for 1 year.
Intervention Type
Device
Intervention Name(s)
Endoscopic mucosal resection(EMR) by mucosectomy kit.
Other Intervention Name(s)
Duette multi-band mucosectomy kit (Cook Medical).
Intervention Description
EMR or surveillance every 2 months.
Primary Outcome Measure Information:
Title
Complete histological eradication of Barrett's esophagus
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complete histological clearance of dysplasia
Time Frame
12 months
Title
Complication rates
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects shall be screened according to the following inclusion criteria. An answer of "no" to any inclusion criterion disqualifies a subject from participating in this study. Patients age: > 18 years Subject has documented diagnosis of Barrett's esophagus, maximum endoscopic length of no more than C2M5 (i.e. no more than 2cm of circumferential extent and no more than 5cm of tongues) containing HGD/EC as follows: HGD or EC documented on biopsy within previous 6 months from enrollment Histology slides reviewed at central pathology service for ERADICATE Trial confirm HGD/EC. Endoscopically visible lesion/area/pattern in a patient with HGD/EC either by high definition white light endoscopy, narrow band imaging, confocal laser endomicroscopy, or another enhanced imaging tool. Ability to take oral proton pump inhibitor For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan Ability to discontinue aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation procedures Ability of provide written, informed consent and understands the responsibilities of trial participation NOTE: At the Kansas City Veterans Hospital, participants must be eligible for care at the VA in order to be enrolled. Other sites listed are able to enroll non-veterans. Exclusion Criteria: Subjects shall be screened according to the following exclusion criteria. An answer of "yes" to any exclusion criterion disqualifies a subject from participating in this study. Extent of BE >C2M5 The subject is pregnant or planning a pregnancy during the study period (12 months after treatment) Esophageal stricture preventing passage of endoscope or catheter Active erosive esophagitis History of malignancy of the esophagus, esophageal varices or coagulopathy Prior radiation therapy to the esophagus, except head and neck region radiation therapy. Any previous ablation therapy within the esophagus (photodynamic therapy, multipolar electrocoagulation, argon plasma coagulation, laser treatment, or other) Any previous EMR in the esophagus Any previous esophageal surgery, including fundoplication Evidence of esophageal varices during treatment endoscopy Subject has a life-expectancy of less than two years due to an underlying medical condition 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: Implantable cardiac defibrillator, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the ERADICATE trial. Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prateek Sharma, MD
Organizational Affiliation
Kansas City VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20032324
Citation
Sharma P. Clinical practice. Barrett's esophagus. N Engl J Med. 2009 Dec 24;361(26):2548-56. doi: 10.1056/NEJMcp0902173. No abstract available. Erratum In: N Engl J Med. 2010 Apr 15;362(15):1450.
Results Reference
background
PubMed Identifier
9827707
Citation
Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53.
Results Reference
background
PubMed Identifier
15236196
Citation
Sharma P, McQuaid K, Dent J, Fennerty MB, Sampliner R, Spechler S, Cameron A, Corley D, Falk G, Goldblum J, Hunter J, Jankowski J, Lundell L, Reid B, Shaheen NJ, Sonnenberg A, Wang K, Weinstein W; AGA Chicago Workshop. A critical review of the diagnosis and management of Barrett's esophagus: the AGA Chicago Workshop. Gastroenterology. 2004 Jul;127(1):310-30. doi: 10.1053/j.gastro.2004.04.010.
Results Reference
background
PubMed Identifier
11375945
Citation
Buttar NS, Wang KK, Sebo TJ, Riehle DM, Krishnadath KK, Lutzke LS, Anderson MA, Petterson TM, Burgart LJ. Extent of high-grade dysplasia in Barrett's esophagus correlates with risk of adenocarcinoma. Gastroenterology. 2001 Jun;120(7):1630-9. doi: 10.1053/gast.2001.25111.
Results Reference
background
PubMed Identifier
11095322
Citation
Reid BJ, Blount PL, Feng Z, Levine DS. Optimizing endoscopic biopsy detection of early cancers in Barrett's high-grade dysplasia. Am J Gastroenterol. 2000 Nov;95(11):3089-96. doi: 10.1111/j.1572-0241.2000.03182.x.
Results Reference
background
PubMed Identifier
10950031
Citation
Weston AP, Sharma P, Topalovski M, Richards R, Cherian R, Dixon A. Long-term follow-up of Barrett's high-grade dysplasia. Am J Gastroenterol. 2000 Aug;95(8):1888-93. doi: 10.1111/j.1572-0241.2000.02234.x.
Results Reference
background
PubMed Identifier
8678620
Citation
Heitmiller RF, Redmond M, Hamilton SR. Barrett's esophagus with high-grade dysplasia. An indication for prophylactic esophagectomy. Ann Surg. 1996 Jul;224(1):66-71. doi: 10.1097/00000658-199607000-00010.
Results Reference
background
PubMed Identifier
12444180
Citation
Hulscher JB, van Sandick JW, de Boer AG, Wijnhoven BP, Tijssen JG, Fockens P, Stalmeier PF, ten Kate FJ, van Dekken H, Obertop H, Tilanus HW, van Lanschot JJ. Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the esophagus. N Engl J Med. 2002 Nov 21;347(21):1662-9. doi: 10.1056/NEJMoa022343.
Results Reference
background
PubMed Identifier
16780561
Citation
Waxman I, Raju GS, Critchlow J, Antonioli DA, Spechler SJ. High-frequency probe ultrasonography has limited accuracy for detecting invasive adenocarcinoma in patients with Barrett's esophagus and high-grade dysplasia or intramucosal carcinoma: a case series. Am J Gastroenterol. 2006 Aug;101(8):1773-9. doi: 10.1111/j.1572-0241.2006.00617.x. Epub 2006 Jun 16.
Results Reference
background
PubMed Identifier
15990814
Citation
Larghi A, Lightdale CJ, Memeo L, Bhagat G, Okpara N, Rotterdam H. EUS followed by EMR for staging of high-grade dysplasia and early cancer in Barrett's esophagus. Gastrointest Endosc. 2005 Jul;62(1):16-23. doi: 10.1016/s0016-5107(05)00319-6.
Results Reference
background
PubMed Identifier
1948615
Citation
Inoue H, Endo M, Takeshita K, Kawano T, Goseki N, Takiguchi T, Yoshino K. Endoscopic resection of early-stage esophageal cancer. Surg Endosc. 1991;5(2):59-62. doi: 10.1007/BF00316837.
Results Reference
background
PubMed Identifier
15326573
Citation
Giovannini M, Bories E, Pesenti C, Moutardier V, Monges G, Danisi C, Lelong B, Delpero JR. Circumferential endoscopic mucosal resection in Barrett's esophagus with high-grade intraepithelial neoplasia or mucosal cancer. Preliminary results in 21 patients. Endoscopy. 2004 Sep;36(9):782-7. doi: 10.1055/s-2004-825813.
Results Reference
background
PubMed Identifier
12776032
Citation
Seewald S, Akaraviputh T, Seitz U, Brand B, Groth S, Mendoza G, He X, Thonke F, Stolte M, Schroeder S, Soehendra N. Circumferential EMR and complete removal of Barrett's epithelium: a new approach to management of Barrett's esophagus containing high-grade intraepithelial neoplasia and intramucosal carcinoma. Gastrointest Endosc. 2003 Jun;57(7):854-9. doi: 10.1016/s0016-5107(03)70020-0.
Results Reference
background
PubMed Identifier
16863545
Citation
Peters FP, Kara MA, Rosmolen WD, ten Kate FJ, Krishnadath KK, van Lanschot JJ, Fockens P, Bergman JJ. Stepwise radical endoscopic resection is effective for complete removal of Barrett's esophagus with early neoplasia: a prospective study. Am J Gastroenterol. 2006 Jul;101(7):1449-57. doi: 10.1111/j.1572-0241.2006.00635.x.
Results Reference
background
PubMed Identifier
16425359
Citation
Conio M, Repici A, Cestari R, Blanchi S, Lapertosa G, Missale G, Della Casa D, Villanacci V, Calandri PG, Filiberti R. Endoscopic mucosal resection for high-grade dysplasia and intramucosal carcinoma in Barrett's esophagus: an Italian experience. World J Gastroenterol. 2005 Nov 14;11(42):6650-5. doi: 10.3748/wjg.v11.i42.6650.
Results Reference
background

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Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus

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