Viewing Study NCT04366583



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Last Modification Date: 2024-10-26 @ 1:33 PM
Study NCT ID: NCT04366583
Status: COMPLETED
Last Update Posted: 2020-12-23
First Post: 2020-04-26

Brief Title: Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
Sponsor: Kaohsiung Veterans General Hospital
Organization: Kaohsiung Veterans General Hospital

Study Overview

Official Title: Comparison of Hemostatic Efficacy for Argon Plasma Coagulation vs Hemoclipping Following Distilled Water Injection in Treating High-risk Bleeding Ulcers
Status: COMPLETED
Status Verified Date: 2020-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None