|- candidate number||8405|
|- NTR Number||NTR2510|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-sep-2010|
|- Secondary IDs||08/263 METC AMC|
|- Public Title||Improving practicality of radiofrequency ablation for eradication of Barrett's mucosa: A randomized trial comparing two different treatment regimens for focal ablation using the HALO90 System.|
|- Scientific Title||Improving practicality of radiofrequency ablation for eradication of Barrett's mucosa: A randomized trial comparing two different treatment regimens for focal ablation using the HALO90 System.|
|- hypothesis||We hypothesize that this simplified HALO90 ablation procedure results in an easier and faster ablation procedure, while maintaining efficacy and safety.|
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Barrett's neoplasia, Barrett's dysplasia, Radiofrequency ablation, Intestinal metaplasia, Intraepithelial neoplasia|
|- Inclusion criteria||1. Scheduled HALO90 ablation for BE (with or without neoplasia) after prior circumferential ablation using the HALO360 System for BE with flat low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or for BE (with or without neoplasia) after prior endoscopic resection (ER) for lesions containing HGD or and early cancer;|
2. One or more BE islands with a minimum size of 5-mm;
3. Written informed consent.
BE islands selection/Inclusion criteria:
Maximum size ≤4 adjacent HALO90 applications and <50% of the circumference.
|- Exclusion criteria||1. Patients with endoscopically active inflammation in the treatment zone;|
2. Esophageal stenosis preventing advancement of the endoscope with the HALO90 catheter.
BE islands selection/Exclusion criteria:
1. Prior treatment of the selected islands with HALO90 ablation;
2. Endoscopically visible abnormalities in one of the selected islands;
3. Patients unable to give informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2008|
|- planned closingdate||1-apr-2011|
|- Target number of participants||46|
|- Interventions||Focal endoscopic radiofrequency ablation using the HALO90-catheter of the HALO System: Standard or simplified regimen:|
Prior to ablation the exact location of islands were registered: Distance to biteblock (cm) and the o'clock position, to by able to relocalize the treatment zone at follow-up endoscopy after 2 months.
After mapping and randomization the Barrett’s segment is flushed with the mucolytic agent acetylcysteine (1%) followed by flushing with tap water. The endoscope is removed and the proximal esophagus is thoroughly inspected to exclude the presence of a Zenker’s diverticulum that may make subsequent introduction of the HALO90 cap difficult or dangerous.
The HALO90 cap is attached to the tip of the endoscope at the twelve o’clock position and introduced into the distal esophagus. Visible islands are then treated with 2x15 J/cm2 (40 Watt)): the cap is brought into close contact with the target area and is then activated. The endoscope and the cap are kept in position and immediately a second ablation of the same area is performed. After ablation of an island, the endoscope is gently removed from the mucosa and rotated to remove the coagulum by suctioning through the endoscope. If the squamocolumnar junction (SQJ) has an irregular appearance the SQJ is treated circumferentially, allowing an overlap of 5-10 mm between the adjacent ablations. After all islands and Z-line have been ablated in this manner, the necrotic debris is cleaned off by a combination of suctioning and irrigating tap water. In addition, the HALO90 cap can be used to gently push off the coagulum from the ablation zone. Subsequently, the ablated areas are cleaned by vigorous flushing of water through a spraying catheter. After emptying the stomach, the endoscope is removed, the HALO90 electrode is cleaned and then reintroduced to ablate all treated areas again with 2x15 J/cm2 (40 Watt).
In the simplified HALO90 ablation regimen the target area is treated with 3x15 J/cm2 (40 Watt) ‘single-triple’ regimen without cleaning in between the ablations. Using this regimen the HALO90 ablation device mounted on the endoscope needs to be introduced only once.
|- Primary outcome||Rate of complete removal of BE islets (completely remove yes/no), as scored by the endoscopist (blinded for the allocation of the islands but nor the location of the islands that were randomized and treated) after 2 months as scored during the endoscopy using a standard case record form. |
|- Secondary outcome||1. Percentage of endoscopically visual surface regression of BE epithelium after 2 months as scored by the endoscopist blinded to the treatment regimen during the endoscopy using a standard case record form, by a study monitor;|
2. Number of introductions of the ablation device and endoscope as scored during the endoscopy using a standard case record form by a study monitor;
3. Complications as assessed by a telephone interview one or two days after the procedure and by registration using a standard case record form.
|- Timepoints||1. At follow-up endoscopy 2 months after focal RFA primary endpoint is scored;|
2. During and in the interval from directly after the focal RFA procedure until follow-up endoscopy after 2 months, the secondary endpoints are scored
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|BARRX Medical, Sunnyvale, CA, USA|
|- Brief summary||In this trial we compare two regimen for focal endoscopic radiofrequency ablation treatment. The first regimen is the standardly used regimen (2x2x15J/cm2 with cleaning of the ablation zone and ablation device between 2 ablation passes), while the second regimen is a simplified regimen (3x15J/cm2, without a cleaning step).|
|- Main changes (audit trail)|
|- RECORD||3-sep-2010 - 27-dec-2010|