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

NCT01572987 | Terminated DMC

• 1 other identifier: PS0058
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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).

Conditions

Barrett's Esophagus; Esophageal Neoplasms

Keywords

Barrett's Esophagus; Esophageal neoplasms; Radiofrequency ablation; Endoscopic mucosal resection

Outcome Measures

Primary Outcomes (1)

• Complete histological eradication of Barrett's esophagus

  12 months

Secondary Outcomes (2)

• Complete histological clearance of dysplasia

  12 months

• Complication rates

  12 months

Study Arms (2)

RFA arm

ACTIVE COMPARATOR

Under this arm, study patients will undergo radiofrequency ablation.

Device: Radiofrequency Ablation(RFA) by HALO device.

EMR arm

ACTIVE COMPARATOR

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

Device: Endoscopic mucosal resection(EMR) by mucosectomy kit.

Interventions

Radiofrequency Ablation(RFA) by HALO device. DEVICE

RFA or Surveillance every 2 months for 1 year.

Also known as: HALO Ablation Technology(BÂRRX Medical, Inc).

RFA arm

Endoscopic mucosal resection(EMR) by mucosectomy kit. DEVICE

EMR or surveillance every 2 months.

Also known as: Duette multi-band mucosectomy kit (Cook Medical).

EMR arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• Cook Group Incorporated: collaborator
• Washington University School of Medicine: collaborator
• Columbia University: collaborator
• University of Chicago: collaborator

Study Sites (3)

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63141, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Related Publications (15)

• 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.

  PMID: 20032324 BACKGROUND

• 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.

  PMID: 9827707 BACKGROUND

• 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.

  PMID: 15236196 BACKGROUND

• 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.

  PMID: 11375945 BACKGROUND

• 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.

  PMID: 11095322 BACKGROUND

• 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.

  PMID: 10950031 BACKGROUND

• 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.

  PMID: 8678620 BACKGROUND

• 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.

  PMID: 12444180 BACKGROUND

• 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.

  PMID: 16780561 BACKGROUND

• 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.

  PMID: 15990814 BACKGROUND

• 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.

  PMID: 1948615 BACKGROUND

• 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.

  PMID: 15326573 BACKGROUND

• 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.

  PMID: 12776032 BACKGROUND

• 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.

  PMID: 16863545 BACKGROUND

• 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.

  PMID: 16425359 BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Prateek Sharma, MD

  Kansas City VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: September 1, 2011
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (3)