Clinical trial · Interventional
Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus
NCT01572987CI-TRIAL-00027866ERADICATEterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment goals not being met
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic mucosal resection(EMR) by mucosectomy kit. | Device | — | UNRESOLVED |
| Radiofrequency Ablation(RFA) by HALO device. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- RFA arm
- description
- Under this arm, study patients will undergo radiofrequency ablation.
- interventionNames
- Device: Radiofrequency Ablation(RFA) by HALO device.
- type
- ACTIVE_COMPARATOR
- label
- EMR arm
- description
- Under this arm, the individuals will undergo endoscopic mucosal resection.
- interventionNames
- Device: Endoscopic mucosal resection(EMR) by mucosectomy kit.
Primary outcomes (1)
- measure
- Complete histological eradication of Barrett's esophagus
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDSharma 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
- BACKGROUNDDevesa 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
- BACKGROUNDSharma 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
- BACKGROUNDButtar 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
- BACKGROUNDReid 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
- BACKGROUNDWeston 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
- BACKGROUNDHeitmiller 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.