Gastric Dysplasia Clinical Trial
Official title:
Endoscopic Closure of Mucosal Defect After High-risk Gastric Endoscopic Submucosal Dissection (ESD) - a Pilot Study
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. Delayed haemorrhage is still an important adverse event of ESD, occurring more frequently for gastric lesions. Risk factors identified for delayed haemorrhage include chronic kidney disease, use of antithrombotic agent, lesion size >20mm, specimen size >30mm. Current established methods to prevent this complications could not completely eliminate the chance of bleeding, especially among high-risk cases. Closure of ESD defect may prevent ongoing exposure of submucosal vessels to gastric acid, and further reduce the risk of delayed haemorrhage. The investigators conduct this study to investigate the effect of closing the defect with endoscopic clips and loop. 30 patients who are undergoing gastric ESD deemed high risk of delayed haemorrhage would be recruited, with closure of defect after resection. The rate of delayed haemorrhage would be compared with historical cohort of patients.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 31, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients undergoing elective gastric endoscopic submucosal dissection for epithelial lesions 2. Procedure deemed at high risk of post-procedural hemorrhage due to the following: 1. End stage renal disease (Estimated GFR <15ml/min) 2. Patients on anti-thrombotic agents (Double antiplatelet, warfarin or direct oral anticoagulants) 3. Post ESD mucosal defect size >4cm 3. Target subjects receiving sufficient briefing from the attending physician regarding the content of this study and providing informed consent for participation 4. Over 20 years of age Exclusion Criteria: 1. Recurrent / remnant lesion after previous endoscopic resection 2. Lesions arising from surgical anastomotic site, such as gastrojejunostomy / gastroduodenostomy. 3. Marked electrolyte abnormalities 4. Allergic to components of injection solutions: Epinephrine, hyaluronic acid etc 5. Other cases deemed by the examining physician as unsuitable for safe treatment 6. Patients who refused to participate |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical success rate | Rate of complete closure of the ESD defect in the index endoscopic resection procedure | 1 day | |
Secondary | Clinical success rate | A persistent closure of ESD defect during follow-up endoscopy at 2 weeks | 2 weeks | |
Secondary | Rate of Post-ESD haemorrhage | Presence of blood clots in the stomach or the need for endoscopic hemostasis during urgent endoscopy if patient shows signs suspicious of bleeding | 30 days | |
Secondary | Rate of adverse events of the procedure | Rate of adverse events related to the procedure, graded according to the CTCAE criteria | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01614418 -
Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
|
Phase 1/Phase 2 | |
Completed |
NCT01753544 -
Endoscopic Submucosal Dissection Using a Thulium Laser
|
N/A | |
Recruiting |
NCT04022109 -
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
|
||
Recruiting |
NCT04869618 -
Validation of an Artificial Intelligence System Based on Raman Spectroscopy for Diagnosis of Gastric Premalignant Lesions and Early Gastric Cancer
|
N/A | |
Not yet recruiting |
NCT03546257 -
Magnifying Endoscopy With Narrow Band Imaging Versus Endoscopic Ultrasonography for Prediction of Tumor Invasion Depth in Early Gastric Cancer: A Prospective Comparative Study
|
||
Enrolling by invitation |
NCT01621451 -
Does Early Re-administration of Aspirin/Clopidogrel Increase the Risk of Bleeding From Artificial Ulcer After EMR or ESD?
|
Phase 4 | |
Recruiting |
NCT03250091 -
Surveillance of Patients With Precancerous Lesions of the Stomach
|
||
Enrolling by invitation |
NCT03228095 -
Volatiles in Breath and Headspace Analysis - Diagnostic Markers
|
||
Recruiting |
NCT02197351 -
Narrow Band Imaging for Gastric Neoplasia
|
N/A | |
Completed |
NCT01523912 -
Radiofrequency Ablation for the Treatment of Gastric Dysplasia
|
Phase 4 | |
Recruiting |
NCT04613570 -
SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up
|
N/A | |
Not yet recruiting |
NCT04251403 -
Novel Approach to Surveillance of Gastric Lesions
|
Early Phase 1 | |
Completed |
NCT01688687 -
Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia
|
N/A |