Peptic Ulcer Hemorrhage Clinical Trial
Official title:
A Prospective Randomized Comparison of a Novel Hemostatic Clip (Resolution Clip™) to Combined Epinephrine Injection and Heater Probe Thermocoagulation in the Endoscopic Control of Ulcer Bleeding
To compare the efficacy of a novel endoscopic clipping device(Resolution Clip™) and conventional epinephrine injection and heater probe thermocoagulation in control of peptic ulcer bleeding and prevention of recurrent bleeding
The mortality of peptic ulcer bleeding remains high despite advances in endoscopy and
medical therapy. Endoscopic therapy effectively controls peptic ulcer bleeding and
substantially reduces recurrent bleeding. However, the best endoscopic therapy is still
unclear. The current standard of therapy is injection with diluted epinephrine and heater
probe (3.2mm) thermo-coagulation. However, it may be associated with complications such as
precipitation of myocardial ischemia or heater probe perforation.
Endoscopic clipping is an emerging modality of endoscopic treatment, it mimics the use of
surgical ligature on bleeding artery. Endo-clipping has the theoretical advantage over
injection and heater probe in that the tissue reaction or damage will be much milder.
Resolution Clip™ is a newly developed endo-clipping device. It is superior to older
generations of endo-clips in that it allows repeated closures and re-opening of clip so as
to facilitate accurate deployment onto bleeding artery to ensure its optimal placement for
hemostasis.
Consecutive patients with endoscopically confirmed bleeding peptic ulcer will be invited to
participate in this double-blind, randomised trial, which compares the efficacy of
Resolution clip and conventional dual endoscopic therapy. Patients will be compared for
30-day treatment failure rate.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01125852 -
Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
|
N/A | |
| Completed |
NCT00840008 -
The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding
|
Phase 4 | |
| Terminated |
NCT00164905 -
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage
|
N/A | |
| Completed |
NCT05563714 -
Anticoagulation With Enhanced Gastrointestinal Safety
|
N/A | |
| Completed |
NCT03362281 -
Ilaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients
|
Phase 3 | |
| Completed |
NCT00164931 -
A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer
|
Phase 3 | |
| Completed |
NCT04211194 -
Registry for Upper Gastrointestinal Bleeding
|
||
| Completed |
NCT01241266 -
China Survey of Peptic Ulcer Bleeding
|
N/A | |
| Completed |
NCT00037570 -
Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage
|
Phase 2 | |
| Completed |
NCT00731601 -
Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
|
Phase 4 | |
| Completed |
NCT05248321 -
Precise Delivery of Tranexamic Acid to Enhance Endoscopic Hemostasis for Peptic Ulcer Bleeding
|
N/A | |
| Recruiting |
NCT00687336 -
Helicobacter Pylori Empiric Treatment in Ulcer Bleeding
|
Phase 4 | |
| Not yet recruiting |
NCT06273384 -
Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding
|
||
| Completed |
NCT03163680 -
Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers
|
||
| Completed |
NCT00279123 -
Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers
|
Phase 4 | |
| Completed |
NCT03362268 -
IIaprazole for the Treatment and Prevention of Peptic Ulcer Bleeding in Chinese Patients
|
Phase 2 | |
| Completed |
NCT00573924 -
Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
|
N/A | |
| Withdrawn |
NCT02724150 -
Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
|
Phase 4 | |
| Active, not recruiting |
NCT04536428 -
ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding
|
N/A | |
| Completed |
NCT02197039 -
The Selection Criteria for the Second-look Endoscopy Among Patients With Bleeding Peptic Ulcers
|