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Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers

Primary Purpose

Bleeding Peptic Ulcer

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
argon plasma coagulation
hemoclipping
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding Peptic Ulcer focused on measuring argon plasma coagulation, hemoclipping, distilled water injection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Gastroenterology and Hepatology, Department of Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Argon plasma coagulation plus distilled water injection

Hemoclipping plus distilled water injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality
all-cause deaths were recorded.
Surgery or Arterial Embolization
need for surgery or arterial embolization

Full Information

First Posted
April 26, 2020
Last Updated
November 29, 2020
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT04366583
Brief Title
Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
Official Title
Comparison of Hemostatic Efficacy for Argon Plasma Coagulation vs Hemoclipping Following Distilled Water Injection in Treating High-risk Bleeding Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 9, 2012 (Actual)
Primary Completion Date
February 28, 2016 (Actual)
Study Completion Date
April 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Peptic Ulcer
Keywords
argon plasma coagulation, hemoclipping, distilled water injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Argon plasma coagulation plus distilled water injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Hemoclipping plus distilled water injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
argon plasma coagulation
Intervention Description
Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)
Intervention Type
Device
Intervention Name(s)
hemoclipping
Intervention Description
clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)
Primary Outcome Measure Information:
Title
Number of Participants With Rebleeding
Description
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
Secondary Outcome Measure Information:
Title
Mortality
Description
all-cause deaths were recorded.
Time Frame
up to 30 days
Title
Surgery or Arterial Embolization
Description
need for surgery or arterial embolization
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chi Chen, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Director
Facility Information:
Facility Name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers

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