RECRUITINGINTERVENTIONAL
Hemostatic Forceps vs. Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers
A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers
About This Trial
A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.
Who May Be Eligible (Plain English)
Who May Qualify:
1. The patient with upper gastrointestinal hemorrhage age ≥ 18 years old
2. The patient with gastroduodenal ulcer with indication for hemostatic intervention including 2.1 Forrest classification 1a (Active spurting) 2.2 Forrest classification 1b (Active oozing) 2.3 Forrest classification 2a (Non-bleeding visible vessel; NBVV) 2.4 Forrest classification 2b (Adherent clot) with lesion underneath clot which need hemostatic intervention including active spurting, active oozing or non-bleeding visible vessel
Who Should NOT Join This Trial:
1. Uncorrectable hemostasis laboratory including serum platelet \< 50000 /mm3 or International Normalized Ratio (INR) \>1.5
2. Bleeding from cancerous gastroduodenal ulcer
3. The patient with history of gastric surgery
4. The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment
5. The patient with history of proton pump inhibitor allergy
6. Pregnant
7. The patient deny to participate in the study
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. The patient with upper gastrointestinal hemorrhage age ≥ 18 years old
2. The patient with gastroduodenal ulcer with indication for hemostatic intervention including 2.1 Forrest classification 1a (Active spurting) 2.2 Forrest classification 1b (Active oozing) 2.3 Forrest classification 2a (Non-bleeding visible vessel; NBVV) 2.4 Forrest classification 2b (Adherent clot) with lesion underneath clot which need hemostatic intervention including active spurting, active oozing or non-bleeding visible vessel
Exclusion Criteria:
1. Uncorrectable hemostasis laboratory including serum platelet \< 50000 /mm3 or International Normalized Ratio (INR) \>1.5
2. Bleeding from cancerous gastroduodenal ulcer
3. The patient with history of gastric surgery
4. The patient with history of bleeding gastroduodenal ulcer within 30 days prior to enrollment
5. The patient with history of proton pump inhibitor allergy
6. Pregnant
7. The patient deny to participate in the study
Treatments Being Tested
DEVICE
Hemostatic Forceps
The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
DEVICE
Bipolar Electrocautery Probes
The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.
Locations (1)
Faculty of internal medicine siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, Thailand