Back to Search
Start Over
Efficacy of endoscopic submucosal resection with a ligation device for small rectal neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial (BANDIT trial).
- Source :
-
BMC gastroenterology [BMC Gastroenterol] 2024 Feb 08; Vol. 24 (1), pp. 69. Date of Electronic Publication: 2024 Feb 08. - Publication Year :
- 2024
-
Abstract
- Background: Endoscopic resection is widely accepted as a local treatment for rectal neuroendocrine tumors sized ≤ 10 mm. However, there is no consensus on the best method for the endoscopic resection of rectal neuroendocrine tumors. As a simplified endoscopic procedure, endoscopic submucosal resection with a ligation device (ESMR-L) indicates a histologically complete resection rate comparable to that of endoscopic submucosal dissection (ESD). We hypothesized that ESMR-L than ESD would be preferred for rectal neuroendocrine tumors. Hence, this trial aimed to verify whether ESMR-L is non-inferior to ESD in terms of histologically complete resection rate.<br />Methods: This is a prospective, open-label, multicenter, non-inferiority, randomized controlled trial of two parallel groups, conducted at the Shizuoka Cancer Center and 31 other institutions in Japan. Patients with a lesion endoscopically diagnosed as a rectal neuroendocrine tumor ≤ 10 mm are eligible for inclusion. A total of 266 patients will be recruited and randomized to undergo either ESD or ESMR-L. The primary endpoint is the rate of en bloc resection with histologically tumor-free margins (R0 resection). Secondary endpoints include en bloc resection rate, procedure time, adverse events, hospitalization days, total devices and agents cost, adverse event rate between groups with and without resection site closure, outcomes between expert and non-expert endoscopists, and factors associated with R0 resection failure. The sample size is determined based on the assumption that the R0 resection rate will be 95.2% in the ESD group and 95.3% in the ESMR-L group, with a non-inferiority margin of 8%. With a one-sided significance level of 0.05 and a power of 80%, 226 participants are required. Assuming a dropout rate of 15%, 266 patients will be included in this study.<br />Discussion: This is the first multicenter randomized controlled trial comparing ESD and ESMR-L for the R0 resection of rectal neuroendocrine tumors ≤ 10 mm. This will provide valuable information for standardizing endoscopic resection methods for rectal neuroendocrine tumors.<br />Trial Registration: Japan Registry of Clinical Trials, jRCTs042210124. Registered on Jan 6, 2022.<br /> (© 2024. The Author(s).)
- Subjects :
- Humans
Prospective Studies
Retrospective Studies
Ligation
Treatment Outcome
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Neuroendocrine Tumors surgery
Neuroendocrine Tumors pathology
Rectal Neoplasms surgery
Rectal Neoplasms pathology
Endoscopic Mucosal Resection methods
Subjects
Details
- Language :
- English
- ISSN :
- 1471-230X
- Volume :
- 24
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- BMC gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 38331727
- Full Text :
- https://doi.org/10.1186/s12876-024-03130-0