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

NCT ID: NCT01572987

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2017-05-31

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.

Conditions

Barrett's Esophagus; Esophageal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA arm

Under this arm, study patients will undergo radiofrequency ablation.

Group Type: ACTIVE_COMPARATOR

Radiofrequency Ablation(RFA) by HALO device.

Intervention Type: DEVICE

RFA or Surveillance every 2 months for 1 year.

EMR arm

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

Group Type: ACTIVE_COMPARATOR

Endoscopic mucosal resection(EMR) by mucosectomy kit.

Intervention Type: DEVICE

EMR or surveillance every 2 months.

Interventions

Radiofrequency Ablation(RFA) by HALO device.

RFA or Surveillance every 2 months for 1 year.

Intervention Type: DEVICE

Endoscopic mucosal resection(EMR) by mucosectomy kit.

EMR or surveillance every 2 months.

Intervention Type: DEVICE

Other Intervention Names

HALO Ablation Technology(BÂRRX Medical, Inc).; Duette multi-band mucosectomy kit (Cook Medical).

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role: collaborator

Cook Group Incorporated

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

Midwest Biomedical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

PRATEEK SHARMA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prateek Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City VA Medical Center

Locations

University Of Chicago

Chicago, Illinois, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Columbia University

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20032324 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9827707 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15236196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11375945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11095322 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10950031 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8678620 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12444180 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16780561 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15990814 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1948615 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15326573 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12776032 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16863545 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16425359 (View on PubMed)

Other Identifiers

PS0058

Identifier Type: -

Identifier Source: org_study_id