Status:
UNKNOWN
Endoscopic Closure of Gastric ESD Defect
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Gastric Dysplasia
Gastric Cancer in Situ
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot study to investigate the usefulness of closure of mucosal defect after gastric endoscopic submucosal dissection (ESD) in patients that are at high risk of post-procedural haemorrhage. ...
Detailed Description
Endoscopic submucosal dissection (ESD) is an endoscopic technique aiming to achieve en-bloc resection of mucosal neoplastic lesion in the gastrointestinal tract. Since the first report of ESD in 2002,...
Eligibility Criteria
Inclusion
- Patients undergoing elective gastric endoscopic submucosal dissection for epithelial lesions
- Procedure deemed at high risk of post-procedural hemorrhage due to the following:
- End stage renal disease (Estimated GFR \<15ml/min)
- Patients on anti-thrombotic agents (Double antiplatelet, warfarin or direct oral anticoagulants)
- Post ESD mucosal defect size \>4cm
- Target subjects receiving sufficient briefing from the attending physician regarding the content of this study and providing informed consent for participation
- Over 20 years of age
Exclusion
- Recurrent / remnant lesion after previous endoscopic resection
- Lesions arising from surgical anastomotic site, such as gastrojejunostomy / gastroduodenostomy.
- Marked electrolyte abnormalities
- Allergic to components of injection solutions: Epinephrine, hyaluronic acid etc
- Other cases deemed by the examining physician as unsuitable for safe treatment
- Patients who refused to participate
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04282707
Start Date
July 1 2020
End Date
March 31 2022
Last Update
August 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong