Bleeding Peptic Ulcer
Conditions
Keywords
argon plasma coagulation, hemoclipping, distilled water injection
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.
Interventions
DEVICEargon plasma coagulation
Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)
DEVICEhemoclipping
clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mortality | up to 30 days | all-cause deaths were recorded. |
| Surgery or Arterial Embolization | up to 30 days | need for surgery or arterial embolization |
Countries
Taiwan
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 82 |
| 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) | 84 |
| Total | 166 |
Baseline characteristics
| Characteristic | Hemoclipping Plus Distilled Water Injection | Total | Argon Plasma Coagulation Plus Distilled Water Injection |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 59 Participants | 121 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 45 Participants | 20 Participants |
| Age, Continuous | 66.0 years STANDARD_DEVIATION 12.5 | 67.0 years STANDARD_DEVIATION 11.7 | 67.9 years STANDARD_DEVIATION 10.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 84 Participants | 166 Participants | 82 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 84 Participants | 166 Participants | 82 Participants |
| Sex: Female, Male Female | 22 Participants | 53 Participants | 31 Participants |
| Sex: Female, Male Male | 62 Participants | 113 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 1 / 84 |
| other Total, other adverse events | 0 / 82 | 0 / 84 |
| serious Total, serious adverse events | 1 / 82 | 1 / 84 |
Outcome results
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.
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Argon Plasma Coagulation Plus Distilled Water Injection | Number of Participants With Rebleeding | 3 Participants |
| Hemoclipping Plus Distilled Water Injection | Number of Participants With Rebleeding | 4 Participants |
Secondary
Mortality
all-cause deaths were recorded.
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Argon Plasma Coagulation Plus Distilled Water Injection | Mortality | 0 Participants |
| Hemoclipping Plus Distilled Water Injection | Mortality | 1 Participants |
Secondary
Surgery or Arterial Embolization
need for surgery or arterial embolization
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Argon Plasma Coagulation Plus Distilled Water Injection | Surgery or Arterial Embolization | 0 Participants |
| Hemoclipping Plus Distilled Water Injection | Surgery or Arterial Embolization | 1 Participants |