A Phase 4 interventional study of argon plasma coagulation and hemoclipping in Bleeding Peptic Ulcer, sponsored by Kaohsiung Veterans General Hospital.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-23.
Sponsored by Kaohsiung Veterans General Hospital. · Phase 4, Interventional, and Treatment
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.
193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.
This study's enrollment of 166 is above the median of 150 across 142 interventional studies indexed under Peptic Ulcer.
Browse Peptic Ulcer studies →Kaohsiung Veterans General Hospital. is the lead sponsor of 102 studies on the registry; 12 are open to participants now.
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． 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 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
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
Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)
clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)
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
Mortality
all-cause deaths were recorded.
Time frame: up to 30 days
Surgery or Arterial Embolization
need for surgery or arterial embolization
Time frame: up to 30 days
| Milestone | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection |
|---|---|---|
| Started | 82 | 84 |
| Completed | 82 | 84 |
| Not completed | 0 | 0 |
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.
| Participants | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection |
|---|---|---|
| Number of Participants With Rebleeding | 3 | 4 |
all-cause deaths were recorded.
| Participants | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection |
|---|---|---|
| Mortality | 0 | 1 |
need for surgery or arterial embolization
| Participants | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection |
|---|---|---|
| Surgery or Arterial Embolization | 0 | 1 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Argon Plasma Coagulation Plus Distilled Water Injection | 0/82 (0%) | 1/82 (1.2%) | 0/82 (0%) |
| Hemoclipping Plus Distilled Water Injection | 1/84 (1.2%) | 1/84 (1.2%) | 0/84 (0%) |
| Event | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection |
|---|---|---|
| procedure-induced bleedingGastrointestinal disorders | 1/82 | 1/84 |
| perforationGastrointestinal disorders | 0/82 | 0/84 |
| strictureGastrointestinal disorders | 0/82 | 0/84 |
| Age, Categorical(Participants) | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 25 | 45 |
| >=65 years | 62 | 59 | 121 |
| Age, Continuous(years) | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection | Total |
|---|---|---|---|
| Mean | 67.9 ± 10.9 | 66.0 ± 12.5 | 67.0 ± 11.7 |
| Sex: Female, Male(Participants) | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection | Total |
|---|---|---|---|
| Female | 31 | 22 | 53 |
| Male | 51 | 62 | 113 |
| Race (NIH/OMB)(Participants) | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 82 | 84 | 166 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Argon Plasma Coagulation Plus Distilled Water Injection | Hemoclipping Plus Distilled Water Injection | Total |
|---|---|---|---|
| Taiwan | 82 | 84 | 166 |
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Kaohsiung Veterans General Hospital.