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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.
【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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argon plasma coagulation plus distilled water injection | Experimental | 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. |
|
| Hemoclipping plus distilled water injection | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| argon plasma coagulation | Device | Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | all-cause deaths were recorded. | up to 30 days |
| Surgery or Arterial Embolization | need for surgery or arterial embolization |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Chi Chen, MD | Kaohsiung Veterans General Hospital. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology and Hepatology, Department of Internal Medicine | Kaohsiung City | 81362 | Taiwan |
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High-risk bleeding ulcers were enrolled and defined as those with stigmata of an actively bleeding visible vessel, a non-bleeding visible vessel or adherent clots. Exclusion criteria were the presence of another possible bleeding site; coexistence of active severe illness, and systemic bleeding tendency.
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| ID | Title | Description |
|---|---|---|
| FG000 | Argon Plasma Coagulation Plus Distilled Water Injection | 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. argon plasma coagulation: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan) |
| FG001 | Hemoclipping Plus Distilled Water Injection | 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. hemoclipping: clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Argon Plasma Coagulation Plus Distilled Water Injection | 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. argon plasma coagulation: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | up to 30 days |
|
30 days
Including all-cause mortality and severe adverse events (namely, procedure-induced bleeding, stricture and perforation)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Argon Plasma Coagulation Plus Distilled Water Injection | 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. argon plasma coagulation: Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| procedure-induced bleeding | Gastrointestinal disorders | Non-systematic Assessment | the bleeding is related to a certain treatment arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Huay-Min Wang | Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan | +886-7-3422121 | 2075 | hmwang@vghks.gov.tw |
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| ID | Term |
|---|---|
| D010438 | Peptic Ulcer Hemorrhage |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D057908 | Argon Plasma Coagulation |
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| D002425 | Cautery |
| D013812 | Therapeutics |
| D006489 | Hemostatic Techniques |
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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
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| hemoclipping | Device | clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan) |
|
| up to 30 days |
| BG001 | Hemoclipping Plus Distilled Water Injection | 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. hemoclipping: clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Hemoclipping Plus Distilled Water Injection | 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. hemoclipping: clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan) |
|
|
| Secondary | Mortality | all-cause deaths were recorded. | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| Secondary | Surgery or Arterial Embolization | need for surgery or arterial embolization | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| 0 |
| 82 |
| 1 |
| 82 |
| 0 |
| 82 |
| EG001 | Hemoclipping Plus Distilled Water Injection | 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. hemoclipping: clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan) | 1 | 84 | 1 | 84 | 0 | 84 |
|
| perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| stricture | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006488 | Hemostasis, Surgical |