Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers

Study Overview
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Brief Summary
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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
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【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.

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

Conditions
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Bleeding Peptic Ulcer

Intervention / Treatment
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* Device: argon plasma coagulation
* Device: hemoclipping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Argon plasma coagulation plus distilled water injection<br>The patients in this group received Argon plasma coagulation therapy, PSD-60/Endoplasma (Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period. | Device: argon plasma coagulation<br>* Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)<br>|
| Active Comparator: Hemoclipping plus distilled water injection<br>The patients in this group received hemoclipping (Olympus HX 110/610, Olympus Corporation, Tokyo, Japan), following distilled water injection at index endoscopy. Then participants were treated with intravenous pantoprazole (Pantoloc i.v., Nycomed GmbH, Singen, Germany) 40 mg every 12 hours during the first 3 days, followed by oral pantoprazole (Pantoloc, Takeda GmbH, Oranienburg, Germany) 40 mg daily until the end of56-day study period. | Device: hemoclipping<br>* clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | all-cause deaths were recorded. | up to 30 days | 
| Surgery or Arterial Embolization | need for surgery or arterial embolization | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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argon plasma coagulation, hemoclipping, distilled water injection