An interventional study of Endoscopic Barbed-clips Suturing in Colorectal Neoplasms, sponsored by Affiliated Hospital to Academy of Military Medical Sciences. Status unknown at 2 sites in China. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Affiliated Hospital to Academy of Military Medical Sciences · Not applicable, Interventional, and Treatment
Endoscopic submucosal dissection (ESD) was developed to allow en bloc resection of colorectal neoplasm. Although colorectal ESD has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-ESD bleeding is one of the major adverse events. After ESD procedure, endoscopists close the defects with devices to prevent complications. A novel endoscopic barbed-clips suturing has been developed to simplify endoscopic closure. In this study, the endoscopic barbed-clips will be evaluated when closing defects in the colon after ESD.
Endoscopic submucosal dissection (ESD) has emerged as a new endoscopic technique that allows en-bloc resection of GI lesions, irrespective of size. The most common complications of the ESD techniques are bleeding and perforation. Several reports have shown that if prophylactic closure of a mucosal defect with clips would reduce the risk of bleeding following endoscopic intervention by ESD. With the advancements in endoscopic therapy, various techniques for prevention of post-ESD complications have been reported. However, there have some limitations including their inability to close large defects and the complexity of the approaches and the need for expensive equipment to complete the procedure. To address these issues, we have devised a novel endoscopic barbed-clips suturing method for mucosal defect closure after endoscopic submucosal dissection of colon. In this study, we assessed the technical feasibility of this novel technique.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 35 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Affiliated Hospital to Academy of Military Medical Sciences is the lead sponsor of 65 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be closed the mucosal defect after colorectal ESD using Endoscopic Barbed-clips Suturing.
Procedure: Endoscopic Barbed-clips Suturing
Endoscopic Barbed-clips Suturing
The technical success rate
Rate of completely closure of the ESD defect
Time frame: 1 day
Endoscopic barbed-clips suturing closure time
The time required to close the defect using endoscopic barbed-clips suturing
Time frame: 1 day
Rate of patients reported with bleeding/perforation post-ESD procedure
Conduct follow-ups for risk of bleeding and perforation after closure
Time frame: 7 days
Clips used post-ESD
Record number of clips needed to close lesion
Time frame: 7 days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Affiliated Hospital to Academy of Military Medical Sciences