Gastroduodenal Ulcer
Conditions
Keywords
Hemostatic Forceps, Bipolar Electrocautery Probes, Gastroduodenal Ulcer, Rebleeding, Hemostasis, Peptic ulcer
Brief summary
A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.
Detailed description
This is a prospective randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. The primary outcome is comparing the hemostatic rates of the devices. Secondary outcomes are rebleeding rate at 7 and 30 days after index intervention, survival rate after intervention, procedure time for achieving hemostasis, number of units of infused blood, duration of hospitalization, and complications.
Interventions
DEVICEHemostatic Forceps
The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
DEVICEBipolar Electrocautery Probes
The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The participants will be randomized for each intervention using sequentially numbered, opaque sealed envelopes after recruitment in the study. The care provider who uses the devices cannot be blinded.
Intervention model description
Hemostatic Forceps versus Bipolar Electrocautery Probes
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes | During esophagogastroduodenoscopy | When the bleeding stopped for at least 2 minutes, it is defined as successful hemostasis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate after intervention | 30 days | Patients who live longer than 30 days after hemostasis will be counted for survival rate. |
| Procedure time for achieving hemostasis | During esophagogastroduodenoscopy | Procedure time will be counted from the time of device insertion to the time of achieving hemostasis. |
| Rebleeding rate at 7 days and 30 days after index intervention | 30 days | After primary hemostasis, patients will be follow up at 7 and 30 days for evidence of rebleeding. |
| Duration of hospitalization | 30 days | The length of hospital stay. |
| Complications of hemostatic interventions | 30 days | Complications related to intervention include perforation, infection, and organ failure |
| Number of units of infused blood | 30 days | Number of red cell units which are transfused to the patients. |
Countries
Thailand
Contacts
Primary ContactUayporn Kaosombattwattana, MD
Outcome results
None listed