Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps for Acute Peptic Ulcer Bleeding

Active Peptic Ulcer Disease/GI Bleeding Clinical Trial

Official title:

Efficacy of Hemostasis by Soft Coagulation Using Endoscopic Hemostatic Forceps in Comparison With Argon Plasma Coagulation for Acute Peptic Ulcer Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020603
• Other study ID #: GUB2013
• Status: Completed
• Phase: N/A
• First received: December 15, 2013
• Last updated: January 20, 2016
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Endoscopic high-frequency soft coagulation is available for the management of bleeding or nonbleeding visible vessels during endoscopic submucosal dissection. However, its efficacy on peptic ulcer bleeding has not been elucidated so far. The aim of this study was to evaluate the efficacy of hemostasis with soft coagulation using hemostatic forceps by comparing it with argon plasma coagulation (APC) in a prospective, randomized trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age greater than 18 years

• peptic ulcer with stigmata of recent hemorrhage

Exclusion Criteria:

• malignant ulcer

• previous gastric surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Active Peptic Ulcer Disease/GI Bleeding
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Device:
• epinephrine injection plus soft coagulation using hemostatic forceps

• epinephrine injection plus argon plasma coagulation

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of bleeding within four weeks after initial hemostasis		up to 24 months	No
Secondary	initial hemostasis rate		up to 24 months	No