Clinical trial NCT06393907: Hemostatic Forceps vs. Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers
Official title: A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroduodenal Ulcer
Keywords: Hemostatic Forceps
Bipolar Electrocautery Probes
Gastroduodenal Ulcer
Rebleeding
Hemostasis
Peptic ulcer
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hemostatic Forceps versus Bipolar Electrocautery Probes
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes
timeFrame: During esophagogastroduodenoscopy
Secondary outcomes:
measure: Rebleeding rate at 7 days and 30 days after index intervention
timeFrame: 30 days
measure: Survival rate after intervention
timeFrame: 30 days
measure: Procedure time for achieving hemostasis
timeFrame: During esophagogastroduodenoscopy
measure: Number of units of infused blood
timeFrame: 30 days
measure: Duration of hospitalization
timeFrame: 30 days
measure: Complications of hemostatic interventions
timeFrame: 30 days
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of internal medicine siriraj hospital, Mahidol university
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Uayporn Kaosombatwattana, MD
role: PRINCIPAL_INVESTIGATOR
References:
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