Comparing hemostatic forceps and bipolar electrocautery for treating bleeding ulcers

A Randomized Trial of Hemostatic Forceps Versus Bipolar Electrocautery Probes for High-Risk Bleeding Gastroduodenal Ulcers

This study is testing whether using special forceps or a heat tool is better for stopping bleeding in patients with serious stomach ulcers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mahidol University (other)
• Locations: 1 site (Bangkok Noi, Bangkok)
• Trial ID: NCT06393907 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective randomized controlled trial aimed at evaluating the efficacy of hemostatic forceps versus bipolar electrocautery probes in patients with high-risk bleeding gastroduodenal ulcers. The primary outcome focuses on comparing the hemostatic rates of both devices, while secondary outcomes include assessing rebleeding rates at 7 and 30 days post-intervention, survival rates, procedure times, blood transfusion requirements, hospitalization duration, and any complications arising from the interventions. The study aims to provide insights into the most effective method for managing severe bleeding in gastroduodenal ulcers.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with high-risk bleeding gastroduodenal ulcers requiring hemostatic intervention.

Not a fit: Patients with uncorrectable hemostasis issues, cancerous ulcers, recent bleeding history, or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with high-risk bleeding gastroduodenal ulcers, potentially reducing rebleeding rates and improving patient outcomes.

How similar studies have performed: Other studies have shown varying success with similar hemostatic interventions, but this specific comparison of devices is novel.

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

Where this trial is running

Bangkok Noi, Bangkok

• Faculty of internal medicine siriraj hospital, Mahidol university — Bangkok Noi, Bangkok, Thailand (RECRUITING)

Study contacts

• Principal investigator: Uayporn Kaosombatwattana, MD — Mahidol University
• Study coordinator: Uayporn Kaosombattwattana, MD

Conditions: Gastroduodenal Ulcer, Hemostatic Forceps, Bipolar Electrocautery Probes, Rebleeding, Hemostasis, Peptic ulcer