Bleeding Ulcers Clinical Trial
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.
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment