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

April 30, 2024 updated by: Uayporn, Mahidol University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Uayporn Kaosombattwattana, MD
  • Phone Number: +66619245953
  • Email: Koigi214@gmail.com

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of internal medicine siriraj hospital, Mahidol university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Hemostatic Forceps
The experimental device will be used for control bleeding in high risk gastroduodenal ulcers.
Other Names:
  • Coagrasper (Olympus, Tokyo, Japan)
Active Comparator: 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.
Device: Bipolar Electrocautery Probes
The active comparator devices will be used for control bleeding in high risk gastroduodenal ulcers.
Other Names:
  • Gold probe (Boston Scientific, Massachusetts, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing hemostatic rate between hemostatic forceps and bipolar electrocautery probes
Time Frame: During esophagogastroduodenoscopy
When the bleeding stopped for at least 2 minutes, it is defined as successful hemostasis.
During esophagogastroduodenoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding rate at 7 days and 30 days after index intervention
Time Frame: 30 days
After primary hemostasis, patients will be follow up at 7 and 30 days for evidence of rebleeding.
30 days
Survival rate after intervention
Time Frame: 30 days
Patients who live longer than 30 days after hemostasis will be counted for survival rate.
30 days
Procedure time for achieving hemostasis
Time Frame: During esophagogastroduodenoscopy
Procedure time will be counted from the time of device insertion to the time of achieving hemostasis.
During esophagogastroduodenoscopy
Number of units of infused blood
Time Frame: 30 days
Number of red cell units which are transfused to the patients.
30 days
Duration of hospitalization
Time Frame: 30 days
The length of hospital stay.
30 days
Complications of hemostatic interventions
Time Frame: 30 days
Complications related to intervention include perforation, infection, and organ failure
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Uayporn Kaosombatwattana, MD, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

March 26, 2026

Study Completion (Estimated)

April 26, 2026

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 223/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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