Clinical trial NCT02241044: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding Ulcers
Keywords: argon plasma coagulation, bleeding peptic ulcer
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: rebleeding
timeFrame: up to 30 days
Secondary outcomes:
measure: mortality
timeFrame: up to 30 days
measure: Surgery
timeFrame: up to 30 days
measure: sever adverse events
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Division of Gastroenterology, Department of Internal Medicine
Study officials:
affiliation: Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital
name: Huay-Min Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.