Phase 4
N=166
Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
Bleeding Peptic Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT04366583 ↗Enrolled (actual)
166
Serious AEs
1.2%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Rebleeding — 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- argon plasma coagulation (Device); hemoclipping (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kaohsiung Veterans General Hospital.
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Rebleeding |
3; 4 | — |
| SECONDARY Mortality |
0; 1 | — |
| SECONDARY Surgery or Arterial Embolization |
0; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
． high-risk peptic ulcer bleeding. High-risk bleeding ulcers were defined as participants with stigmata of a bleeding visible vessels (eg, spurting, oozing), a non-bleeding visible vessels (NBVV) or adherent clot.4 A NBVV at endoscopy was defined as a raised red, red-blue or pale hemispheric vessel protruding from the ulcer bed, without active bleeding. An adherent clot was defined as an overlying blood clot that was resistant to vigorous irrigation.
Exclusion Criteria
- the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis)
- coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen)
- treatment with an anticoagulant (eg, warfarin)
- pregnancy
- the presence of operated stomach
- refusal to participate in the study
Data sourced from ClinicalTrials.gov (NCT04366583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.