Clinical trial NCT04366583: Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
Official title: Comparison of Hemostatic Efficacy for Argon Plasma Coagulation vs Hemoclipping Following Distilled Water Injection in Treating High-risk Bleeding Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding Peptic Ulcer
Keywords: argon plasma coagulation
hemoclipping
distilled water injection
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 166
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention device: argon plasma coagulation ( (PSD-60/Endoplasma, Olympus Corp., Tokyo,Japan) ; hemoclipping (Olympus HX 110/610) Intervention drug: distilled water design setting: argon plasma coagulation plus distilled water injection vs hemoclipping plus distilled water
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Rebleeding
timeFrame: up to 30 days
Secondary outcomes:
measure: Mortality
timeFrame: up to 30 days
measure: Surgery or Arterial Embolization
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Division of Gastroenterology and Hepatology, Department of Internal Medicine
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Wen-Chi Chen, MD
role: STUDY_DIRECTOR
References: