Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers

NCT04366583 | Completed Phase 4 Results FDA Device

• 1 other identifier: VGHKS12-CT1-17
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding Peptic Ulcer

Keywords

argon plasma coagulation; hemoclipping; distilled water injection

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 30 days

Secondary Outcomes (2)

• Mortality

  up to 30 days

• Surgery or Arterial Embolization

  up to 30 days

Study Arms (2)

Argon plasma coagulation plus distilled water injection

EXPERIMENTAL

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

Hemoclipping plus distilled water injection

ACTIVE COMPARATOR

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

Interventions

argon plasma coagulation DEVICE

Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)

Argon plasma coagulation plus distilled water injection

hemoclipping DEVICE

clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)

Hemoclipping plus distilled water injection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ． 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Kaohsiung City, 81362, Taiwan

Location

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

Results Point of Contact

• Title: Dr. Huay-Min Wang
• Organization: Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

hmwang@vghks.gov.tw

+886-7-3422121

Study Officials

• Wen-Chi Chen, MD

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 and Hepatology, Department of Internal Medicine

Model Details: 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

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: February 9, 2012
• Primary Completion: February 28, 2016
• Study Completion: April 25, 2016
• Last Updated: December 23, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)