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

Esophageal Neoplasms Clinical Trial

— ERADICATE  

Official title:

Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01572987
• Other study ID #: PS0058
• Status: Terminated
• Phase: N/A
• First received: April 4, 2012
• Last updated: May 24, 2017
• Start date: September 2011
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Midwest Biomedical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Esophageal Neoplasms

Intervention

Device:
• Radiofrequency Ablation(RFA) by HALO device.
RFA or Surveillance every 2 months for 1 year.
• Endoscopic mucosal resection(EMR) by mucosectomy kit.
EMR or surveillance every 2 months.

Locations

Country	Name	City	State
United States	University Of Chicago	Chicago	Illinois
United States	Columbia University	New York	New York
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (6)

Lead Sponsor	Collaborator
Midwest Biomedical Research Foundation	American Society for Gastrointestinal Endoscopy, Columbia University, Cook, University of Chicago, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Sharma P. Clinical practice. Barrett's esophagus. N Engl J Med. 2009 Dec 24;361(26):2548-56. doi: 10.1056/NEJMcp0902173. Review. Erratum in: N Engl J Med. 2010 Apr 15;362(15):1450. — View 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. Epub 2006 Jun 16. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete histological eradication of Barrett's esophagus		12 months
Secondary	Complete histological clearance of dysplasia		12 months
Secondary	Complication rates		12 months