Hemostatic Forceps vs. Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

Mahidol University

Status: Enrolling

Conditions: Gastroduodenal Ulcer

Treatments: Device: Hemostatic Forceps; Device: Bipolar Electrocautery Probes

Study type: Interventional

Funder types: Other

Identifiers

NCT06393907

Si 223/2024

Details and patient eligibility

About

A randomized controlled trial to evaluate the efficacy of hemostatic forceps and bipolar electrocautery probes in patient with high risk bleeding gastroduodenal ulcers.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Hemostatic forceps

Experimental group

Description:

Hemostatic forceps will be used for control bleeding with electrocautery unit setting: 80 W, effect 4, soft coagulation mode for 1-2 seconds.

Treatment:

Device: Hemostatic Forceps

Bipolar electrocautery probes

Active Comparator group

Description:

Bipolar electrocautery probes will be used for control bleeding with electrocautery unit setting: effect 2, soft coagulation bipolar mode for 8-10 seconds.

Treatment:

Device: Bipolar Electrocautery Probes