Argon Plasma Coagulation for Bleeding Peptic Ulcers

NCT02241044 | Completed Phase 4

• 1 other identifier: VGHKS98-CT8-13
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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).

Conditions

Bleeding Ulcers

Keywords

argon plasma coagulation, bleeding peptic ulcer

Outcome Measures

Primary Outcomes (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.

  up to 30 days

Secondary Outcomes (3)

• mortality

  up to 30 days

• Surgery

  up to 30 days

• sever adverse events

  up to 30 days

Study Arms (2)

the Combined group

ACTIVE COMPARATOR

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.

Device: Argon plasma coagulation; Device: Distilled water

the Injection group

PLACEBO COMPARATOR

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.

Device: Distilled water

Interventions

Argon plasma coagulation DEVICE

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.

Also known as: PSD-60/Endoplasma (Olympus Corporation, Tokyo, Japan)

the Combined group

Distilled water DEVICE

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.

the Combined group; the Injection group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Division of Gastroenterology, Department of Internal Medicine

Kaohsiung City, 81362, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 26266385 DERIVED

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocoagulation; Cautery; Therapeutics; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Study Officials

• Huay-Min Wang, MD

  Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung,Taiwan

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 16, 2014
• Study Start: October 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

TW (1)