NCT04366583

Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers

Comparison of Hemostatic Efficacy for Argon Plasma Coagulation vs Hemoclipping Following Distilled Water Injection in Treating High-risk Bleeding Ulcers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Kaohsiung Veterans General Hospital. · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper gastrointestinal bleeding. However, the additional hemostatic efficacy of argon plasma coagulation (APC) has not been widely investigated. We designed a randomized trial comparing APC plus injection therapy vs hemoclipping plus injection therapy for peptic ulcer bleeding.

Detailed description

【Goals and Background 】 Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper gastrointestinal bleeding. Many endoscopic devices have been demonstrated to be effective in the hemostasis of bleeding ulcers. However, the additional hemostatic efficacy of argon plasma coagulation (APC) after endoscopic injection therapy has not been widely investigated. 【Study】 From Feb. 2012 to April 2016, consecutive patients with high-risk bleeding ulcers, characterized by active bleeding, non-bleeding visible vessels and adherent clots, were admitted to our hospital. They prospectively randomly underwent either APC therapy plus distilled water injection or Hemoclipping plus distilled water injection. Pantoprazole infusion was conducted during the fasting period after endoscopy and orally for 8 weeks to encourage ulcer healing. Episodes of rebleeding were retreated with endoscopic combination therapy. Patients who did not benefit from retreatment underwent emergency surgery or arterial embolization.

Conditions

• Bleeding Peptic Ulcer

Interventions

Type	Name	Description
DEVICE	argon plasma coagulation	Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)
DEVICE	hemoclipping	clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)

Timeline

• Start date: 2012-02-09
• Primary completion: 2016-02-28
• Completion: 2016-04-25
• First posted: 2020-04-29
• Last updated: 2020-12-23
• Results posted: 2020-10-22

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study