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

Not Applicable

Recruiting

• Conditions: Gastroduodenal Ulcer
• Interventions: Device: Hemostatic Forceps; Device: Bipolar Electrocautery Probes

• Registration Number: NCT06393907
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2024-03-26
• Status Verified: 2024-04
• Study First Submitted: 2024-04-28
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Primary Completion: 2026-03-26
• Study Completion: 2026-04-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemostatic forceps	Hemostatic Forceps	Hemostatic forceps will be used for control bleeding with electrocautery unit setting: 80 W, effect 4, soft coagulation mode for 1-2 seconds.
Bipolar electrocautery probes	Bipolar Electrocautery Probes	Bipolar electrocautery probes will be used for control bleeding with electrocautery unit setting: effect 2, soft coagulation bipolar mode for 8-10 seconds.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Duration of hospitalization	30 days	The length of hospital stay.
Number of units of infused blood	30 days	Number of red cell units which are transfused to the patients.
Complications of hemostatic interventions	30 days	Complications related to intervention include perforation, infection, and organ failure

Trial Locations

Locations (1)

Faculty of internal medicine siriraj hospital, Mahidol university; 🇹🇭 Bangkok Noi, Bangkok, Thailand