Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers

Phase 4

Completed

• Conditions: Bleeding Peptic Ulcer

• Registration Number: NCT04366583
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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 Timeline

• Study Start: 2012-02-09
• Primary Completion: 2016-02-28
• Study Completion: 2016-04-25
• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-26
• Study First Posted: 2020-04-29
• Results First Submitted: 2020-09-27
• Results First Submitted QC: 2020-09-27
• Results First Posted: 2020-10-22
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-29
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Rebleeding	up to 30 days	Rebleeding was observed for a 30-day study period. One or more the following criteria were considered as evidence of recurrent bleeding: aspiration of fresh blood from a nasogastric or orogastric tube; pulse rate over 100 beats per minute; a drop in systolic blood pressure exceeding 30 mmHg; or continue coffee ground emesis or melena with a decline in hemoglobin of at least 2g/dL.

Secondary Outcome Measures

Name	Time	Method
Surgery or Arterial Embolization	up to 30 days	need for surgery or arterial embolization
Mortality	up to 30 days	all-cause deaths were recorded.

Trial Locations

Locations (1)

Division of Gastroenterology and Hepatology, Department of Internal Medicine; 🇨🇳 Kaohsiung, Taiwan