|- candidate number||3930|
|- NTR Number||NTR1435|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-sep-2008|
|- Secondary IDs||MEC05/160 |
|- Public Title||A randomized trial comparing the ER-cap technique and the multiband mucosectomy technique for piecemeal endoscopic resection of early Barrett neoplasia.|
|- Scientific Title||A randomized trial comparing the ER-cap technique and the multiband mucosectomy technique for piecemeal endoscopic resection of early Barrett neoplasia.|
|- hypothesis||We hypothesize that endoscopic resection (ER) of early neoplasia arising in Barrett esophagus (BE) using the multiband mucosectomy (MBM) technique is equally effective in removing early neoplasia, but may be faster, cheaper and possibly safer than the standard ER-cap technique.|
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Barrett's neoplasia, Barrett's cancer, Barrett's dysplasia, Endoscopic resection|
|- Inclusion criteria||1. BE with biopsy proven high-grade dysplasia (HGD) and/or early cancer (EC); |
2. In case of visible lesions: type 0-IIa, 0-IIb, 0-IIc, or combinations of these types;
3. No suspicion of submucosal invasion on endoscopy or endosonography;
4. No signs of lymph node and/or distant metastases on endosonography and CT-scanning of thorax and abdomen;
5. Written informed consent.
|- Exclusion criteria||1. Lesion with suspicion on submucosal invasion;|
2. Unable to give informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2005|
|- planned closingdate||1-jul-2009|
|- Target number of participants||80|
|- Interventions||Patients are randomized to undergo endoscopic resection using either the standard ER-cap technique, or the newer multiband mucosectomy technique.|
|- Primary outcome||- Rate of radically resected lesions; |
- Number and severity of complications.
|- Secondary outcome||- Time per procedure;|
- Number of resected pieces per procedure,
- Costs of disposables per procedure;
- Maximum diameter of resected specimens;
- Maximum thickness of submucosa in resected specimens.
|- Timepoints||The patient will be randomized and treated in the same endoscopy session.
|- 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), Department of Hepato- and Gastroenterology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Hepato- and Gastroenterology|
|- Brief summary||This study will be performed at the AMC in Amsterdam, St. Antonius Hospital in Nieuwegein, Catharina Hospital in Eindhoven and the Gasthuisberg in Leuven.
Endoscopic resection (ER) is an important treatment modality for patients with Barrett esophagus (BE) containing high-grade dysplasia (HGD) or early cancer (EC). The most widely used ER technique, the ER-cap technique, requires submucosal lifting and prelooping of a snare in the cap, making it technically demanding and laborious when used for piecemeal resections. In addition, a new snare is needed for every resection.
The newer multi-band mucosectomy (MBM) technique uses a modified variceal band ligator and requires no submucosal lifting or prelooping of a snare, and multiple resections can be performed with the same snare. Aim of this study is to prospectively compare ER-cap and MBM for piecemeal ER in BE.
A total of 80 patients with BE-HGD/EC scheduled for piecemeal ER will be included. After delineation of the area to be resected, patients will be randomized to ER-cap or MBM. Assessment criteria are: number of resections/procedure, procedure time, time/resected specimen, complications, maximum diameter of specimens, and costs of disposables.
We hypothesize that both techniques will be equally effective, but MBM may be quicker, cheaper and may even be associated with less complications.
|- Main changes (audit trail)|
|- RECORD||5-sep-2008 - 18-sep-2008|