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Argon Plasma Coagulation for Bleeding Peptic Ulcers

Primary Purpose

Bleeding Ulcers

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

About this trial

This is an interventional treatment trial for Bleeding Ulcers focused on measuring argon plasma coagulation, bleeding peptic ulcer

Eligibility Criteria

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

Inclusion Criteria:

  • (i) over 20 years of age and (ii) patients with high-risk peptic ulcer bleeding.

Exclusion Criteria:

  • (i) the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis); (ii) coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen); (iii) treatment with an anticoagulant (eg, warfarin); (iv) pregnancy; (v) the presence of operated stomach or; (vi) refusal to participate in the study.

Sites / Locations

  • Division of Gastroenterology, Department of Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

the Combined group

the Injection group

Arm Description

The Combined group patients 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 of 56-day study period.

Injection group patients underwent distilled water alone at index endoscopy. Then patients 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 of 56-day study period.

Outcomes

Primary Outcome Measures

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
the need for surgery wihtin 30 days
sever adverse events
Namely, stricture, obstruction and perforation

Full Information

First Posted
September 11, 2014
Last Updated
September 13, 2014
Sponsor
Kaohsiung Veterans General Hospital.
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1. Study Identification

Unique Protocol Identification Number
NCT02241044
Brief Title
Argon Plasma Coagulation for Bleeding Peptic Ulcers
Official Title
Ivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: A second endoscopic method added to injection therapy is recommended for high-risk bleeding peptic ulcers. Many endoscopic devices have been proved as useful hemostatic instruments, whereas the hemostatic efficacy of argon plasma coagulation (APC) has not been widely investigated. Aim: This study was designed to know whether additional APC treatment could influence the hemostatic efficacy after endoscopic injection therapy in treating high-risk bleeding ulcers. Methods: From October 2010 to January 2012, eligible patients who had high-risk bleeding ulcers were admitted to our hospital. They prospectively randomly underwent either APC therapy plus distilled water injection or distilled water injection alone. 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 transarterial embolization (TAE).
Detailed Description
Patients and methods Study cohort Patients with acute upper gastrointestinal bleeding (AUGIB) who were admitted to Kaohsiung Veterans General Hospital between January 2011 and January 2012 were screened. Inclusion criteria were (i) over 20 years of age and (ii) patients with high-risk peptic ulcer bleeding. Acute hemorrhage from upper gastrointestine was defined as classical presentation with hematemesis, coffee-ground emesis, and/or melena. 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 were as follows: (i) the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis); (ii) coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen); (iii) treatment with an anticoagulant (eg, warfarin); (iv) pregnancy; (v) the presence of operated stomach or; (vi) refusal to participate in the study. In current study, baseline characteristics of both study groups were collected at the first 24 hours after admission. Some definitions of events were expressed herein: smoking was defined as inhalation of smoke from burning tobacco daily in recent 3 months; habitual consumption of alcohol was defined as participants imbibing alcohol twice or more per week in recent 3 months; shock was considered systolic blood pressure less than 90 mm Hg or diastolic less than 60 mmHg, and heart rate over 100 beats per minute; comorbid diseases included unresolved malignancy, diabetes mellitus, liver cirrhosis, uremia, congestive heart failure, chronic pulmonary obstructive disease and pneumonia; and coagulopathy was defined as prothrombin time > 14 seconds and/or activated partial thromboplastin time > 45 seconds. Randomization In this prospective, parallel-group, randomized controlled trial, eligible patients were randomized into two groups using opaque-sealed envelopes numbered according to a table of random numbers before the fist therapeutic endoscopy (index endoscopy): the Combined group and the Injection group. Informed consent was obtained from each enrolled participant. Combined group patients received APC therapy following distilled water injection at index endoscopy. Injection group patients underwent distilled water alone at index endoscopy. Thereafter both treatment groups 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 of 56-day study period. Primary end point was rebleeding. Secondary end points included initial hemostasis, the need for surgery, transfusion requirements, the period of hospitalization, severe adverse event (stricture, obstruction or perforation) and death at 30 days postrandomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Ulcers
Keywords
argon plasma coagulation, bleeding peptic ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the Combined group
Arm Type
Active Comparator
Arm Description
The Combined group patients 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 of 56-day study period.
Arm Title
the Injection group
Arm Type
Placebo Comparator
Arm Description
Injection group patients underwent distilled water alone at index endoscopy. Then patients 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 of 56-day study period.
Intervention Type
Device
Intervention Name(s)
Argon plasma coagulation
Other Intervention Name(s)
PSD-60/Endoplasma (Olympus Corporation, Tokyo, Japan)
Intervention Description
Argon plasma coagulation therapy was realized by an Olympus electrosurgical unit/APC unit (PSD-60/Endoplasma, Olympus Corporation, Tokyo, Japan), and its catheters were 2.3mm and 3.5 mm equipped with different endoscope channels.7 APC treatment used a coagulation mode at gas flow/power settings of 1.5L/min and 40 watt for duodenal ulcers and 40-60 watt for gastric ulcers.10 Operative distance between the probe and target bleeding ranged from 2 to 8 mm. Air warranted to be sucked frequently at endoscopy in an attempt at decrease of APC-induced smoke and gastric decompensation, with appropriate treatment of high-risk bleeding ulcers.
Intervention Type
Device
Intervention Name(s)
Distilled water
Intervention Description
Distilled water was then applied in aliquots of 0.5-2.0 mL, at and around the site of target bleeding, up to 25.0 ml if necessary. Injection amount was determined by endoscopists according to ulcer or vessel size and its location.
Primary Outcome Measure Information:
Title
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
Description
the need for surgery wihtin 30 days
Time Frame
up to 30 days
Title
sever adverse events
Description
Namely, stricture, obstruction and perforation
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (i) over 20 years of age and (ii) patients with high-risk peptic ulcer bleeding. Exclusion Criteria: (i) the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis); (ii) coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen); (iii) treatment with an anticoagulant (eg, warfarin); (iv) pregnancy; (v) the presence of operated stomach or; (vi) refusal to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huay-Min Wang, MD
Organizational Affiliation
Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterology, Department of Internal Medicine
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26266385
Citation
Wang HM, Tsai WL, Yu HC, Chan HH, Chen WC, Lin KH, Tsai TJ, Kao SS, Sun WC, Hsu PI. Improvement of Short-Term Outcomes for High-Risk Bleeding Peptic Ulcers With Addition of Argon Plasma Coagulation Following Endoscopic Injection Therapy: A Randomized Controlled Trial. Medicine (Baltimore). 2015 Aug;94(32):e1343. doi: 10.1097/MD.0000000000001343.
Results Reference
derived

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Argon Plasma Coagulation for Bleeding Peptic Ulcers

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