|- candidate number||8516|
|- NTR Number||NTR2542|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-okt-2010|
|- Secondary IDs||09/109 METC AMC|
|- Public Title||Single step treatment using radiofrequency ablation and endoscopic resection for Barrett esophagus containing early neoplasia in an endoscopically visible abnormality.|
|- Scientific Title||Single step treatment using radiofrequency ablation and endoscopic resection for Barrett esophagus containing early neoplasia in an endoscopically visible abnormality.|
|- hypothesis||For BE patients with visible lesions containing high-grade dysplasia (HGD) or early cancer (EC) upon biopsy, a single session treatment in which the BE is first ablated using radiofrequency ablation (RFA) followed by the endoscopic resection (ER) of the visible abnormality is feasible and safe. This allows for a combined treatment which otherwise would require 2 separate procedures but more importantly, it preserves the diagnostic and therapeutic efficacy of ER but prevents that RFA is hampered by esophageal scarring after the ER. |
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Radiofrequency ablation, Endoscopic resection|
|- Inclusion criteria||1. Age between 18 and 85 years inclusive;|
2. BE with a minimal circumferential extent of 2 cm;
3. An endoscopically visible abnormality of type 0-I, 0-IIa, 0-IIc or a combination thereof, irrespective of its size;
4. A biopsy proven histological diagnosis of HGD and/or EC on two separate endoscopic sampling procedures;
5. HGD, G1 or G2 cancer in the endoscopic resection specimens, without involvement of the deeper resection margins, no lymphatic invasion, and a maximum infiltration depth into the submucosa <500µm;
6. Written informed consent.
|- Exclusion criteria||1. Any prior endoscopic treatment for esophageal adenocarcinoma of BE associated neoplasia;|
2. Signs of local or distant metastasis on EUS (EUS is obligatory);
3. Signs of distant metastasis on CT-scan of thorax and/or abdomen (optional for mucosal lesions);
4. Any of the following findings in any of the ER specimens:
A. G3 or G4 tumor differentiation;
B. Lymphatic invasion;
C. Infiltration into the submucosa >500µm;
D. A positive deeper resection margin.
5. Endoscopic signs of esophageal varices;
6. Esophageal stenosis not allowing passage of a therapeutic endoscope with an ER-cap;
7. Prior esophageal surgery (except fundoplication).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-dec-2008|
|- planned closingdate||1-nov-2010|
|- Target number of participants||24|
|- Interventions||Endoscopic treatment with RFA and ER in a single endoscopic session in patients with a BE containing visible abnormalities with HGD or EC upon biopsy.
All patients will undergo a circumferential RF ablation using the HALO360+ system, followed by endoscopic resection of any visible abnormality in the BE during the same procedure. Prior to the ablation, the area to be resected will be marked by placing electrocoagulation markers. After the ablation, the delineated area will be resected using either the multi-band mucosectomy technique of the ER-cap technique. The second ablation session is scheduled after 3 months followed by 2-monthly ablation sessions until all endoscopically visible BE has been removed.
|- Primary outcome||1. The percentage of BE regression at 3 months follow-up after the combined ER and RFA procedure;|
2. The rate of acute (i.e. < 3 days) complications after therapeutic procedures;
3. The rate of late (such as esophageal stenosis) complications occurring during the treatment phase or during follow-up.
|- Secondary outcome||1. The rate of complete remission of HGD and EC in all biopsies obtained at 12 months follow-up;|
2. The rate of complete remission of BE, defined as the endoscopic absence of columnar lined epithelium upon inspection with NBI and the absence of intestinal metaplasia in all biopsy specimens obtained at 12 months follow-up;
3. The number of endoscopic therapeutic procedures;
4. The frequency, severity, and duration of patient's symptoms after the first therapeutic session as assessed with standardised questionnaires and patient diaries;
5. Maximum depth of injury (a) complete epithelial ablation, (b) maximum depth of ablation assessed as epithelium, lamina propria, muscularis mucosa, submucosa ('ablation' defined as any sign of irreversible injury: coagulum, loss of cellular architecture, and loss of nuclei).
|- Timepoints||1. 0 months: Combined ER and RFA procedure;|
2. 3 months: Follow-up endoscopy with subsequent treatment;
3. 12 months: Assessment of primary endpoints.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- 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||A pilot 24 patients treated with endoscopic resection (ER) and radiofrequency ablation (RFA) in a single treatment session, looking at feasibility, efficacy and safety.|
|- Main changes (audit trail)|
|- RECORD||5-okt-2010 - 11-apr-2011|