A Phase 4 interventional study of pantoloc 40 mg and somatostatin or terlipressin in Esophageal Varices and Bleeding, sponsored by National Science Council, Taiwan. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-04-28.
Sponsored by National Science Council, Taiwan · Phase 4, Interventional, and Treatment
Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL.
Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL.
Thus, we designed a controlled trial to compare the initial hemostasis, early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus somatostatin infusion or losec infusion for 5 days.
AIMS:
To investigate whether the combination of EVL and somatostatin is superior to the combination of EVL and losec in terms of efficacy in the arresting of acute esophageal variceal bleeding and very early rebleeding.
169 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.
This study's enrollment of 118 is above the median of 104 across 109 interventional studies indexed under Esophageal and Gastric Varices.
Browse Esophageal and Gastric Varices studies →National Science Council, Taiwan is the lead sponsor of 18 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Somatostatin 6mg in 500 cc 5% dextrose, 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge.
Drug: somatostatin or terlipressin
Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5
Drug: pantoloc 40 mg
pantoloc iv. infusion per day
Also known as: pantoloc, a proton pump inhibitor
Somatostatin 6mg in 500 cc 5% dextrose, 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge.
Also known as: somatostatin and terlipressin are vasoconstrictors.
Success rate of initial hemostasis
Definition of initial hemostasis Initial hemostasis was defined as achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria. Very early rebleeding was defined as: UGI bleeding occurred after initial hemostasis and within 5 days after enrollment. UGI bleeding was proven to be from esophageal varices.
Time frame: 5 days
very early rebleeding
Very early rebleeding is defined as episodes of variceal bleeding 48-120 hours after treatment.
Time frame: 48-120 hours after treatment
The amount of blood transfusion within 42 days
The amount of blood transfusion during admission was recorded.
Time frame: 42 days
Mortality
Mortality within 42 days was recorded and compared.
Time frame: within 42 days
The size and number of ulcers on varices
If p't agrees, a second look endoscopy is performed to detect ulcers.
Time frame: 2 weeks after treatment
No study locations are listed for this record.
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Esophageal and Gastric Varices→
National Science Council, Taiwan