Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02241044
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2014-09-11
Brief Title:
Argon Plasma Coagulation for Bleeding Peptic Ulcers
Sponsor:
Kaohsiung Veterans General Hospital
Organization:
Kaohsiung Veterans General Hospital
Study Overview
Official Title:
Ivision of Gastroenterology Department of Internal Medicine Kaohsiung Veterans General Hospital Kaohsiung Taiwan
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 clot4 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 andor 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 iv 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
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 andor 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 iv 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None