Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers

Bleeding Peptic Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366583
• Other study ID #: VGHKS12-CT1-17
• Status: Completed
• Phase: Phase 4
• Start date: February 9, 2012
• Est. completion date: April 25, 2016

Study information

• Verified date: November 2020
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 25, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Peptic Ulcer
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Device:
• argon plasma coagulation
Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)
• hemoclipping
clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)

Locations

Country	Name	City	State
Taiwan	Division of Gastroenterology and Hepatology, Department of Internal Medicine	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Rebleeding	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.	up to 30 days
Secondary	Mortality	all-cause deaths were recorded.	up to 30 days
Secondary	Surgery or Arterial Embolization	need for surgery or arterial embolization	up to 30 days