Article Text
Abstract
Introduction Patients scheduled to undergo oesophageal, gastric and colorectal endoscopic submucosal dissection (ESD) are to be investigated to verify the efficacy of dual red imaging (DRI) for establishing haemostasis during ESD.
Methods and analysis The trial is designed as a multicentre, open-label randomised, parallel-group, controlled intervention study. Registered patients will be randomly assigned to DRI and white light imaging (WLI) groups. In the DRI group, the mucosal incision and submucosal dissection will be performed by WLI, and haemostasis will be managed by DRI when bleeding occurs. In the WLI group, the mucosal incision and submucosal dissection are to be performed by WLI and the haemostasis management is to be performed by WLI. The primary endpoint is the time from the recognition of bleeding up to the achievement of complete haemostasis (haemostasis time). The secondary endpoints are the operation time, the proportion of cases in which perforation occurs, and the psychological stress experienced by the endoscopist during haemostasis treatment.
Ethics and dissemination This trial was approved by the Keio University Review Board for Clinical Trials (5 December 2016).
Discussion This will be the first multicentre collaborative research using DRI for haemostasis treatment during ESD. When the safety and simplicity of DRI as a treatment for haemostasis during ESD can be proven, the ESD procedure can be simplified and disseminated more widely in clinical practice.
Trial registration number UMIN000025134
- cancer
- clinical trials
- endoscopic procedures
- gastrointestinal haemorrhage
- imaging
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Footnotes
Contributors AF participated in the design and statistical analysis plan of the study, and is responsible for managing data, handling monitoring. YS, SA, SH, HY, YM, TU and IS conceived of this study and participated in meetings to design the study and coordinate details. SA, KN, YM, SK, IS and YT submitted the design to an ethics committee at each participating institution. NY oversaw the study as chief and provided personal research funding. AF, SA, KN, YM, SK, IS, YT, TN, TM and YO were responsible for registering the cases. All of the authors read and approved this manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study complies with the World Medical Association’s Declaration of Helsinki, Ethical
Guidelines for Medical and Health Research Involving Human Subjects, and Act on the Protection of Personal Information. It was approved by the Keio University Review Board for Clinical Trials (5 December 2016).
Provenance and peer review Not commissioned; externally peer reviewed.