Colorectal Neoplasms
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEndoscopic Barbed-clips Suturing
Endoscopic Barbed-clips Suturing
Sponsors
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged≥20 years with a single clinically or histologically diagnosed colorectal lesions of 20-50mm eligible for which fulfilled criteria for ESD;
Exclusion criteria
* Patients with coagulopathy (platelet count \< 5 × 10\*4, prothrombin time international normalized ratio \> 2, * medical conditions requiring the continuous use of antithrombotic agents * prior abdominal surgery or radiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The technical success rate | 1 day | Rate of completely closure of the ESD defect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic barbed-clips suturing closure time | 1 day | The time required to close the defect using endoscopic barbed-clips suturing |
| Rate of patients reported with bleeding/perforation post-ESD procedure | 7 days | Conduct follow-ups for risk of bleeding and perforation after closure |
| Clips used post-ESD | 7 days | Record number of clips needed to close lesion |
Countries
China
Contacts
Primary ContactYiliang Bi, Dr.
Backup ContactPei Deng, Dr.
Outcome results
None listed