search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Self-sizing Radiofrequency Ablation balloon for eradication of Barrett's esophagus: a randomized trial comparing three different treatment regimens


- candidate number22203
- NTR NumberNTR5191
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mei-2015
- Secondary IDs2014_380 METC AMC NL51663.018.14 CCMO
- Public TitleSelf-sizing Radiofrequency Ablation balloon for eradication of Barrett's esophagus: a randomized trial comparing three different treatment regimens
- Scientific TitleSelf-sizing Radiofrequency Ablation balloon for eradication of Barrett's esophagus: a randomized trial comparing three different treatment regimens
- ACRONYM
- hypothesisThe percentage of endoscopic resolution of Barrett’s esophagus at 3 months is non-inferior with the simple protocol versus the standard protocol
- Healt Condition(s) or Problem(s) studiedBarrett's dysplasia, Barrett's esophagus, Barrett's neoplasia
- Inclusion criteria1. Patients aged 18-85 years, with biopsy proven LGD, HGD or EC in a BE after local expert pathology review.
2. Scheduled circumferential ablation for BE with flat LGD, HGD, or for BE after prior endoscopic resection (ER) for lesions containing HGD or EC (<2 cm and <50% of the circumference).
3. Pretreatment biopsies and/or ER specimens reviewed by a local expert pathologist.
4. Written informed consent.
- Exclusion criteria1. Patients with a BE segment < 2cm or >15 cm prior to ER.
2. Any prior endoscopic ablation treatment.
3. Significant esophageal stenosis prior to initial treatment, preventing passage of a therapeutic endoscope OR any prior endoscopic dilatation for esophageal stenosis.
4. Presence of esophageal varices.
5. Anti-coagulant therapy (apart from aspirin or NSAID) that cannot be discontinued prior to ER or RFA, OR uncorrectable hemostatic disorders.
6. In case of prior ER: patients with ER of multiple lesions in a single ER session are not eligible, if one of the resections measures more than the aforementioned size criteria, OR if resections of different lesions are not separated by a free circumferential segment of at least 1 cm.
7. In case of prior ER: a specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (>T1sm1), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion.
8. In case of prior ER: invasive cancer in any of the biopsies obtained at high-resolution endoscopy after ER.
9. An interval > 6 months between the last high-resolution endoscopy with biopsies and RFA.
10. An interval < 6 weeks between ER and RFA.
11. Patients unable to give informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-dec-2016
- Target number of participants108
- InterventionsCircumferential radiofrequency ablation of Barrett's esophagus with the Self-sizing RFA balloon.
Inspection of the Barrett’s segment and randomization
The esophagus is evaluated using white light high-resolution endoscopy (WLE) and narrow band imaging (NBI). The extent of columnar lined esophagus is documented according to the Prague C&M classification15 and by taking still images with WLE+NBI at 1 cm intervals. In the absence of visible abnormalities and no severe stenosis, patients are subsequently randomized to circumferential ablation with the Self Sizing RFA balloon using the simplified or the standard ablation regiment.
Patients will be blinded for the administered treatment regimen.
Standard ablation regimen
After mapping and randomization, the Barrett’s segment is flushed with the mucolytic agent acetylcysteine (1%) followed by flushing with tap water. The Self Sizing RFA balloon (GI Solutions Covidien, Sunnyvale, CA) is then introduced and positioned at the desired treatment zone. The device is inflated, and the electrode unfurls until the electrode contacts the esophageal wall. Under visual control the BE is ablated (12 J/cm2 at 300 Watt) working proximal to distal using visual repositioning. A small overlap (i.e. <1cm) between ablation zones is allowed. After the first ablation pass, the endoscope is removed followed by removal of the ablation catheter. The coagulum is cleaned off the balloon catheter. The endoscope is reintroduced to irrigate and suction the ablation zone. A distal attachment cap may be attached to the tip of the endoscope to gently wipe of the coagulum from the ablated segment. After irrigating and suctioning the debris away as much as possible, the Self Sizing RFA RCT November 2014 vs 1 Page 10 van 16 ablation zone is cleaned by forcefully flushing water through a spraying catheter. The stomach is emptied and deflated, the endoscope is removed and the ablation catheter is reintroduced to repeat the ablation. After this second ablation no additional cleaning of the ablation zone is required. First, the endoscope is removed, followed by careful removal of the ablation catheter.
Simplified ablation regimen
In the simplified ablation regimen flushing with the mucolytic agent acetylcysteine (1%) is not performed, but the esophageal wall will cleaned with water through the waterjet channel of the endoscope. After the first ablation (12 J/cm2 at 300W), immediately a second ablation is performed of the same zone without a cleaning step. After deflation, the balloon is advanced distally to ablate subsequent zones with a double ablation in an identical way.
- Primary outcomePrimary outcome:
Percentage of endoscopically visual surface regression of BE epithelium at 3 months, as scored by two independent endoscopists blinded to the treatment regimen.
- Secondary outcome1. Adverse events
2. Patient’s discomfort after RFA treatment
3. Procedure time
- Timepoints1. At follow-up endscopy at 3 months after the circumferential RFA treatment the primary endpoint will be scored
2. During and in the interval from directly after the circumferential RFA procedure until follow-up endoscopy after 3 months, the secondary endpoints are scored
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr J.J.G.H.M. Bergman
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.J.G.H.M. Bergman
- Sponsor/Initiator KU Gasthuisberg
- Funding
(Source(s) of Monetary or Material Support)
Covidien Nederland
- PublicationsN/A
- Brief summaryIn this trial, three regimens for circumferential radiofrequency ablation treatment with the RFA self-sizing balloonWill be compared The first regimen is the standardly used regimen (1x-clean-1x) The two simple regimens are the simplified protocol with 2x-ablation-no clean and the simplified protocol with 1x ablation-no clean.
- Main changes (audit trail)23-dec-2015: Amedement METC Amsterdam:

NEW Hypothesis:
The percentage of endoscopic resolution of Barrett’s esophagus at 3 months is non-inferior with two simple protocol versus the standard protocol.

NEW Interventions:
Circumferential radiofrequency ablation of Barrett's esophagus with the Self-sizing RFA balloon.
Inspection of the Barrett’s segment and randomization The esophagus is evaluated using white light high-resolution endoscopy (WLE) and narrow band imaging (NBI). The extent of columnar lined esophagus is documented according to the Prague C&M classification15 and by taking still images with WLE+NBI at 1 cm intervals. In the absence of visible abnormalities and no severe stenosis, patients are subsequently randomized to circumferential ablation with the Self Sizing RFA balloon using the simplified or the standard ablation regiment.
Patients will be blinded for the administered treatment regimen.

Standard ablation regimen After mapping and randomization, the Barrett’s segment is flushed with the mucolytic agent acetylcysteine (1%) followed by flushing with tap water. The Self Sizing RFA balloon (GI Solutions Covidien, Sunnyvale, CA) is then introduced and positioned at the desired treatment zone. The device is inflated, and the electrode unfurls until the electrode contacts the esophageal wall. Under visual control the BE is ablated (12 J/cm2 at 300 Watt) working proximal to distal using visual repositioning. A small overlap (i.e. <1cm) between ablation zones is allowed. After the first ablation pass, the endoscope is removed followed by removal of the ablation catheter. The coagulum is cleaned off the balloon catheter. The endoscope is reintroduced to irrigate and suction the ablation zone. A distal attachment cap may be attached to the tip of the endoscope to gently wipe of the coagulum from the ablated segment. After irrigating and suctioning the debris away as much as possible, the Self Sizing RFA RCT November 2014 vs 1 Page 10 van 16 ablation zone is cleaned by forcefully flushing water through a spraying catheter. The stomach is emptied and deflated, the endoscope is removed and the ablation catheter is reintroduced to repeat the ablation. After this second ablation no additional cleaning of the ablation zone is required. First, the endoscope is removed, followed by careful removal of the ablation catheter.

Simplified ablation regimens: In the first simplified ablation regimen flushing with the mucolytic agent acetylcysteine (1%) is not performed, but the esophageal wall will cleaned with water through the waterjet channel of the endoscope. After the first ablation (12 J/cm2 at 300W), immediately a second ablation is performed of the same zone without a cleaning step. After deflation, the balloon is advanced distally to ablate subsequent zones with a double ablation in an identical way.

In the second simplified ablation regimen flushing with the mucolytic agent acetylcysteine (1%) is not performed, but the esophageal wall will cleaned with water through the waterjet channel of the endoscope. There is only one ablation instead of two.
- RECORD18-mei-2015 - 23-dec-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl