Trial Outcomes & Findings for Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers (NCT NCT04366583)
NCT ID: NCT04366583
Last Updated: 2020-12-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
166 participants
Primary outcome timeframe
up to 30 days
Results posted on
2020-12-23
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
84
|
|
Overall Study
COMPLETED
|
82
|
84
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
Baseline characteristics by cohort
| Measure |
Argon Plasma Coagulation Plus Distilled Water Injection
n=82 Participants
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)
|
Hemoclipping Plus Distilled Water Injection
n=84 Participants
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)
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
67.0 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
82 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
82 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 30 daysRebleeding 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.
Outcome measures
| Measure |
Argon Plasma Coagulation Plus Distilled Water Injection
n=82 Participants
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)
|
Hemoclipping Plus Distilled Water Injection
n=84 Participants
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)
|
|---|---|---|
|
Number of Participants With Rebleeding
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysall-cause deaths were recorded.
Outcome measures
| Measure |
Argon Plasma Coagulation Plus Distilled Water Injection
n=82 Participants
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)
|
Hemoclipping Plus Distilled Water Injection
n=84 Participants
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)
|
|---|---|---|
|
Mortality
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysneed for surgery or arterial embolization
Outcome measures
| Measure |
Argon Plasma Coagulation Plus Distilled Water Injection
n=82 Participants
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)
|
Hemoclipping Plus Distilled Water Injection
n=84 Participants
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)
|
|---|---|---|
|
Surgery or Arterial Embolization
|
0 Participants
|
1 Participants
|
Adverse Events
Argon Plasma Coagulation Plus Distilled Water Injection
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Hemoclipping Plus Distilled Water Injection
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Argon Plasma Coagulation Plus Distilled Water Injection
n=82 participants at risk
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)
|
Hemoclipping Plus Distilled Water Injection
n=84 participants at risk
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)
|
|---|---|---|
|
Gastrointestinal disorders
procedure-induced bleeding
|
1.2%
1/82 • Number of events 1 • 30 days
Including all-cause mortality and severe adverse events (namely, procedure-induced bleeding, stricture and perforation)
|
1.2%
1/84 • Number of events 1 • 30 days
Including all-cause mortality and severe adverse events (namely, procedure-induced bleeding, stricture and perforation)
|
|
Gastrointestinal disorders
perforation
|
0.00%
0/82 • 30 days
Including all-cause mortality and severe adverse events (namely, procedure-induced bleeding, stricture and perforation)
|
0.00%
0/84 • 30 days
Including all-cause mortality and severe adverse events (namely, procedure-induced bleeding, stricture and perforation)
|
|
Gastrointestinal disorders
stricture
|
0.00%
0/82 • 30 days
Including all-cause mortality and severe adverse events (namely, procedure-induced bleeding, stricture and perforation)
|
0.00%
0/84 • 30 days
Including all-cause mortality and severe adverse events (namely, procedure-induced bleeding, stricture and perforation)
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Huay-Min Wang
Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
Phone: +886-7-3422121
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place