NCT01572987|TerminatedDMC
Study Stopped
Recruitment goals not being met
Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
ERADICATE
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Sponsor study identifier
interventional
12
1 country
3
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Actual (reported)Study Completion
May 2017
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 4, 2012
Actual (reported)April 6, 2012
Actual (reported)May 2017
Actual (reported)May 2017
Actual (reported)Complete histological eradication of Barrett's esophagus
12 months
Complete histological clearance of dysplasia
12 months
Complication rates
12 months
Under this arm, study patients will undergo radiofrequency ablation.
Under this arm, the individuals will undergo endoscopic mucosal resection.
RFA or Surveillance every 2 months for 1 year.
EMR or surveillance every 2 months.
University Of Chicago
Chicago, Illinois, 60637, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63141, United States
Columbia University
New York, New York, 10032, United States
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.
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.
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.
Prateek Sharma, MD
Kansas City VA Medical Center
12 participants (actual enrollment reported by the registry).
First Submitted
April 4, 2012
First Posted
April 6, 2012
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Cryo Balloon for Residual Barrett's Esophagus
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
May 2017
Actual (reported)Study Completion
May 2017
Actual (reported)Last Updated
May 30, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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