AzTrials
AzTrials

Bleeding UlcersPhase 4NCT02241044

Argon Plasma Coagulation for Bleeding Peptic Ulcers

A Phase 4 study testing Argon plasma coagulation and Distilled water in people with Bleeding Ulcers, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Bleeding Ulcers
What is being tested?
Argon plasma coagulation and Distilled water
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
1 siteTaiwan
Study dates
Oct 2010to Jan 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Division of Gastroenterology, Department of Internal Medicine

    Kaohsiung City, 81362

Other trials in Taiwan

About this study

Official title: Ivision of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

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.

Read more

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).

Read the 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.

Conditions
Bleeding Ulcers
Being tested
Argon plasma coagulation, Distilled water
Keywords
argon plasma coagulation, bleeding peptic ulcer
Medical subject headings
Peptic Ulcer Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Argon plasma coagulationDevice

    Also called PSD-60/Endoplasma (Olympus Corporation, Tokyo, Japan)

    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.

  • Distilled waterDevice

    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.

Study groups in NCT02241044
Study groupRoleWhat they receive
the Combined groupActive comparatorThe 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.
Receives: Device: Argon plasma coagulation; Device: Distilled water
the Injection groupPlacebo comparatorInjection 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.
Receives: Device: Distilled water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 30 days

Secondary outcomes (3)
  1. mortality

    All-cause deaths were recorded.

    Measured: up to 30 days

  2. Surgery

    the need for surgery wihtin 30 days

    Measured: up to 30 days

  3. sever adverse events

    Namely, stricture, obstruction and perforation

    Measured: up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2014 (estimated)
  2. Study startOct 2010
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02241044
Sponsor's protocol ID
VGHKS98-CT8-13
Status last verified
Sep 2014
First submitted
11 Sep 2014
Last updated
16 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26266385

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Argon plasma coagulation and Distilled water in people with Bleeding Ulcers, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rebleeding (time frame: up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02241044, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in