Esophageal Variceal RebleedingPhase 4NCT00863837
Prevention of Esophageal Variceal Rebleeding
A Phase 4 study testing terlipressin (vasoconstrictor) and pantoloc (proton pump inhibitor) in people with Esophageal Variceal Rebleeding, run by National Science and Technology Council, Taiwan.
Trial summary
BACKGROUND: Previous studies showed that the combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Variceal Rebleeding
- What is being tested?
- terlipressin (vasoconstrictor) and pantoloc (proton pump inhibitor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The etiology of portal hypertension is cirrhosis.
- Age ranges between 18-80 y/o.
- Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as:
- when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding) OR
- when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding).
- EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.
Who cannot join
- association with severe systemic illness, such as sepsis, COPD, uremia
- association with gastric variceal bleeding
- failure in the control of bleeding by emergency EVL
- moribund patients, died within 12 hours of enrollment
- Uncooperative
- Ever received EIS, EVL within one month prior to index bleeding
- Child-Pugh's scores > 10
About this study
BACKGROUND: Previous studies showed that the 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, the investigators 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 vasoconstrictor infusion or losec infusion for 5 days.
Read the detailed description
Methods of treatment:
Group 1: Somatostatin 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. Group 2: Pantoloc 20 mg intravenously per day was instituted on enrollment and continued for 5 days.
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.
Treatment failure is defined as failure to control acute bleeding episodes or very early rebleeding.
- Conditions
- Esophageal Variceal Rebleeding
- Being tested
- terlipressin (vasoconstrictor), pantoloc (proton pump inhibitor)
- Keywords
- Acute variceal bleeding, banding ligation, vasoconstrictor, proton pump inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressin (vasoconstrictor)Drug
Also called vasoconstrictor
Ligation plus terlipressin 1mg q6h
pantoloc (proton pump inhibitor)Drug
Also called proton pump inhibitor
Pantoloc infusion (1 vial q.d.); Using pantoloc to reduce rebleed after EVL
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | add pantoloc to reduce ulcer bleeding after banding ligation Receives: Drug: pantoloc (proton pump inhibitor) |
| Arm B: ligation + terlipressin 1mg q6h | Placebo comparator | Arm B, intervention: ligation + terlipressin 1mg q6h Receives: Drug: terlipressin (vasoconstrictor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
very early rebleeding
Measured: 5 days
Secondary outcomes (1)
mortality, complications
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startDec 2006
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Variceal RebleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863837
- Sponsor's protocol ID
- NSC
- Status last verified
- Mar 2009
- First submitted
- 16 Mar 2009
- Last updated
- 18 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Esophageal Variceal Rebleeding
- ClinicalTrials.gov ID
- NCT00863837
- Acronym / sponsor ID
- NSC
- Conditions
- Esophageal Variceal Rebleeding
- Keywords
- Acute variceal bleeding, banding ligation, vasoconstrictor, proton pump inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Study start
- Dec 2006
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Previous studies showed that the 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, the investigators 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 vasoconstrictor infusion or losec infusion for 5 days.
Detailed description
Methods of treatment:
Group 1: Somatostatin 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. Group 2: Pantoloc 20 mg intravenously per day was instituted on enrollment and continued for 5 days.
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.
Treatment failure is defined as failure to control acute bleeding episodes or very early rebleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: pantoloc (proton pump inhibitor)add pantoloc to reduce ulcer bleeding after banding ligation |
| Arm B: ligation + terlipressin 1mg q6h | Placebo comparator | Drug: terlipressin (vasoconstrictor)Arm B, intervention: ligation + terlipressin 1mg q6h |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The etiology of portal hypertension is cirrhosis.
- Age ranges between 18-80 y/o.
- Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as:
- EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.
Key exclusion criteria (7 listed)
- association with severe systemic illness, such as sepsis, COPD, uremia
- association with gastric variceal bleeding
- failure in the control of bleeding by emergency EVL
- moribund patients, died within 12 hours of enrollment
- Uncooperative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| terlipressin (vasoconstrictor)Also: vasoconstrictorLigation plus terlipressin 1mg q6h | Drug | Arm B: ligation + terlipressin 1mg q6h |
| pantoloc (proton pump inhibitor)Also: proton pump inhibitorPantoloc infusion (1 vial q.d.); Using pantoloc to reduce rebleed after EVL | Drug | Arm A |
Primary outcome
very early rebleeding
Time frame: 5 days
1 secondary outcome
mortality, complications
Time frame: 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing terlipressin (vasoconstrictor) and pantoloc (proton pump inhibitor) in people with Esophageal Variceal Rebleeding, run by National Science and Technology Council, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
very early rebleeding (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2009.