Variceal Bleeding, Endoscopic Variceal LigationNCT01809535
Monthly Versus Biweekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
A study testing Wilson-Cook four shooter saeed multi-band ligator in people with Variceal Bleeding, Endoscopic Variceal Ligation, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Endoscopic variceal ligation (EVL) has proved to be effective in the prevention of esophageal variceal rebleeding. However, the optimal interval of EVL remains unclear. Our previous studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low incidence of variceal rebleeding and mortality. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Variceal Bleeding, Endoscopic Variceal Ligation
- What is being tested?
- Wilson-Cook four shooter saeed multi-band ligator
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Oct 2012
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active or recent hemorrhage from esophageal varices;
- portal hypertension caused by cirrhosis
Who cannot join
- age > 80 or <20 years old
- association with hepatocellular carcinoma or other neoplasms;
- association with cerebral vascular accident, uremia, acute coronary syndrome or other severe illnesses;
- history of gastric variceal bleeding;
- a history of undergoing EIS, EVL, cyanoacrylate injection or prior use of beta blocker;
- a history of prior shunt operation or transjugular intrahepatic portosystemic stent shunt (TIPS);
Show all 11Show fewer
- deep jaundice (serum bilirubin > 10 mg/dL);
- encephalopathy equal to or greater than stage II;
- failure in control of index variceal bleeding;
- death within 48 h of admission; or
- refusal to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Monthly Versus Biweekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Endoscopic variceal ligation (EVL) has proved to be effective in the prevention of esophageal variceal rebleeding. However, the optimal interval of EVL remains unclear. Our previous studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low incidence of variceal rebleeding and mortality. In our own opinion, many shallow post-EVL ulcers may hamper the performance of variceal ligation if EVL is performed at intervals of 1-2 weeks. So far the optimal treatment interval remained unknown. The investigators hypothesis the Monthly EVL is superior to the Biweekly EVL in the prevention of esophageal variceal rebleeding in cirrhotic patients.
Read the detailed description
Esophageal varices are the most important portosystemic collaterals owing to their rupture results in variceal hemorrhage, which is a devastating event of portal hypertension. Cirrhotic patients surviving a first episode of variceal rupture have a risk of over 60% of suffering from recurrent bleeding within 1 year and mortality from each rebleeding episode is about 20%. Except for patients with a terminal illness, the secondary preventive measures are required to reduce variceal rebleeding to improve patient survival and clinical outcome. Endoscopic and pharmacological therapies are 2 main methods of intervention used to achieve the treatment goals. Endoscopic therapy contains endoscopic injection sclerotherapy (EIS) or endoscopic variceal ligation (EVL), which would obliterate varices by causing thrombosis and fibrosis formation. However, EVL has currently replaced EIS as the endoscopic therapy of choice because it is safer, more effective, and has lower morbidity rate.
Many experts and scholars suggest to repeat EVL every 1-2 weeks until obliteration of esophageal varices to prevent variceal rebleeding, whereas, there are insufficient data to support the concept that EVL at intervals of 1-2 week is appropriate. Our previous studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low incidence of variceal rebleeding and mortality. In our own opinion, many shallow post-EVL ulcers may hamper the performance of variceal ligation if EVL is performed at intervals of 1-2 weeks. A randomized controlled trial from Japan showed that EVL performed at a bimonthly interval obtained a higher variceal obliteration rate, lower variceal recurrence rate and fewer additional treatments. Bimonthly EVL in the secondary prophylaxis of variceal hemorrhage may be theoretically improper because post-EVL variceal rebleeding could only be significantly reduced in whom variceal obliteration was achieved within a short treatment course. The other retrospective investigation from the United States demonstrated the principal technical aspects of EVL in the prevention of variceal rebleeding, suggesting the benefit of intersession intervals > 3 weeks compared with intervals < 3 weeks.
This randomized controlled study was undertaken to compare the effectiveness and safety of EVL with two different intersession intervals (bimonthly vs. biweekly). In addition, the risk factors that were associated with variceal rebleeding and mortality were analyzed.
- Being tested
- Wilson-Cook four shooter saeed multi-band ligator
- Keywords
- endoscopic variceal ligation, post-EVL ulcer, variceal bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wilson-Cook four shooter saeed multi-band ligatorDevice
Patients in the Monthly group were received EVL at 28-day treatment intervals.Orally 20 mg of rabeprazole (Pariet®) once a day for 2 weeks was given to hasten post-EVL ulcer healing in each treatment session. Once esophageal varices were obliterated, surveillance endoscopy was done every 3 months for one year, then every 6 months to check for recurrent varices.
Wilson-Cook four shooter saeed multi-band ligatorDevice
Patients in the Biweekly group were received EVL at 14-day treatment intervals.Orally 20 mg of rabeprazole (Pariet®) once a day for 2 weeks was given to hasten post-EVL ulcer healing in each treatment session. Once esophageal varices were obliterated, surveillance endoscopy was done every 3 months for one year, then every 6 months to check for recurrent varices.
| Study group | Role | What they receive |
|---|---|---|
| The Monthly EVL | Experimental | Patients in the Monthly group were received EVL at 28-day treatment intervals. Receives: Device: Wilson-Cook four shooter saeed multi-band ligator |
| The Biweekly EVL | Active comparator | Patients in the Biweekly group received repeating EVL every 2 weeks. Receives: Device: Wilson-Cook four shooter saeed multi-band ligator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding
Rebleeding from esophageal varices was defined as the presence of hematemesis, melena or both and the bleeding source was identified to be esophageal varices by an emergency endoscopy. Only those who had a clinically significant bleeding, including hematemesis/melena, > 100 ml of fresh blood drained from nasogastric tube, decrease 3 g hemoglobin if no transfusion is given and transfusion requirement > 2 units of blood in the first 24 hours of admission, were considered rebleeding from portal hypertensive sources.
Measured: From date of randomization until the date of first documented rebleeding, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months
Secondary outcomes (2)
Variceal recurrence
After success in variceal obliteration, recurrence of varices was defined as reappearance of esophageal varices or enlargement of previous residual small varices could be injected or ligated at endoscopy. Variceal recurrence was repeatedly treated by EVL using the same protocol in each study cohort.
Measured: From date of variceal obliteration until the date of first documented variceal recurrence, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months
All-cause death
Causes of mortality included variceal bleeding, non-variceal bleeding or other causes rather than bleeding.
Measured: From date of randomization until the date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startJan 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Variceal Bleeding, Endoscopic Variceal LigationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang-Ming University, Kaohsiung, Taiwan, ROC
- Responsible party
- Principal investigator, Huay-Min Wang, Kaohsiung Veterans General Hospital.
- Investigators
- Huay-Min Wang, MD, Principal investigator, Kaohsiung Veterans General Hospital.Ping-I Hsu, MD, Study director, Kaohsiung Veterans General Hospital.Gin-Ho Lo, MD, Study director, E-DA Hospital, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809535
- Sponsor's protocol ID
- VGHKS97-CT9-10
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang HM, Lo GH, Chen WC, Chan HH, Tsai WL, Yu HC, Tsay FW, Hsu PI. Randomized controlled trial of monthly versus biweekly endoscopic variceal ligation for the prevention of esophageal variceal rebleeding. J Gastroenterol Hepatol. 2014 Jun;29(6):1229-36. doi: 10.1111/jgh.12538.
PubMed 24955452
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Monthly Versus Biweekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
- ClinicalTrials.gov ID
- NCT01809535
- Acronym / sponsor ID
- VGHKS97-CT9-10
- Keywords
- endoscopic variceal ligation, post-EVL ulcer, variceal bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Collaborators
- National Yang-Ming University, Kaohsiung, Taiwan, ROC
- Study start
- Jan 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Mar 2013 (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.
Endoscopic variceal ligation (EVL) has proved to be effective in the prevention of esophageal variceal rebleeding. However, the optimal interval of EVL remains unclear. Our previous studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low incidence of variceal rebleeding and mortality. In our own opinion, many shallow post-EVL ulcers may hamper the performance of variceal ligation if EVL is performed at intervals of 1-2 weeks. So far the optimal treatment interval remained unknown. The investigators hypothesis the Monthly EVL is superior to the Biweekly EVL in the prevention of esophageal variceal rebleeding in cirrhotic patients.
Detailed description
Esophageal varices are the most important portosystemic collaterals owing to their rupture results in variceal hemorrhage, which is a devastating event of portal hypertension. Cirrhotic patients surviving a first episode of variceal rupture have a risk of over 60% of suffering from recurrent bleeding within 1 year and mortality from each rebleeding episode is about 20%. Except for patients with a terminal illness, the secondary preventive measures are required to reduce variceal rebleeding to improve patient survival and clinical outcome. Endoscopic and pharmacological therapies are 2 main methods of intervention used to achieve the treatment goals. Endoscopic therapy contains endoscopic injection sclerotherapy (EIS) or endoscopic variceal ligation (EVL), which would obliterate varices by causing thrombosis and fibrosis formation. However, EVL has currently replaced EIS as the endoscopic therapy of choice because it is safer, more effective, and has lower morbidity rate.
Many experts and scholars suggest to repeat EVL every 1-2 weeks until obliteration of esophageal varices to prevent variceal rebleeding, whereas, there are insufficient data to support the concept that EVL at intervals of 1-2 week is appropriate. Our previous studies demonstrated that repeating EVL every 3-4 weeks could achieve an appreciable low incidence of variceal rebleeding and mortality. In our own opinion, many shallow post-EVL ulcers may hamper the performance of variceal ligation if EVL is performed at intervals of 1-2 weeks. A randomized controlled trial from Japan showed that EVL performed at a bimonthly interval obtained a higher variceal obliteration rate, lower variceal recurrence rate and fewer additional treatments. Bimonthly EVL in the secondary prophylaxis of variceal hemorrhage may be theoretically improper because post-EVL variceal rebleeding could only be significantly reduced in whom variceal obliteration was achieved within a short treatment course. The other retrospective investigation from the United States demonstrated the principal technical aspects of EVL in the prevention of variceal rebleeding, suggesting the benefit of intersession intervals > 3 weeks compared with intervals < 3 weeks.
This randomized controlled study was undertaken to compare the effectiveness and safety of EVL with two different intersession intervals (bimonthly vs. biweekly). In addition, the risk factors that were associated with variceal rebleeding and mortality were analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Monthly EVL | Experimental | Device: Wilson-Cook four shooter saeed multi-band ligatorPatients in the Monthly group were received EVL at 28-day treatment intervals. |
| The Biweekly EVL | Active comparator | Device: Wilson-Cook four shooter saeed multi-band ligatorPatients in the Biweekly group received repeating EVL every 2 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- active or recent hemorrhage from esophageal varices;
- portal hypertension caused by cirrhosis
Key exclusion criteria (11 listed)
- age > 80 or <20 years old
- association with hepatocellular carcinoma or other neoplasms;
- association with cerebral vascular accident, uremia, acute coronary syndrome or other severe illnesses;
- history of gastric variceal bleeding;
- a history of undergoing EIS, EVL, cyanoacrylate injection or prior use of beta blocker;
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 |
|---|---|---|
| Wilson-Cook four shooter saeed multi-band ligatorPatients in the Monthly group were received EVL at 28-day treatment intervals.Orally 20 mg of rabeprazole (Pariet®) once a day for 2 weeks was given to hasten post-EVL ulcer healing in each treatment session. Once esophageal varices were obliterated, surveillance endoscopy was done every 3 months for one year, then every 6 months to check for recurrent varices. | Device | The Biweekly EVL, The Monthly EVL |
| Wilson-Cook four shooter saeed multi-band ligatorPatients in the Biweekly group were received EVL at 14-day treatment intervals.Orally 20 mg of rabeprazole (Pariet®) once a day for 2 weeks was given to hasten post-EVL ulcer healing in each treatment session. Once esophageal varices were obliterated, surveillance endoscopy was done every 3 months for one year, then every 6 months to check for recurrent varices. | Device | The Biweekly EVL, The Monthly EVL |
Primary outcome
Rebleeding
Time frame: From date of randomization until the date of first documented rebleeding, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months
Rebleeding from esophageal varices was defined as the presence of hematemesis, melena or both and the bleeding source was identified to be esophageal varices by an emergency endoscopy. Only those who had a clinically significant bleeding, including hematemesis/melena, > 100 ml of fresh blood drained from nasogastric tube, decrease 3 g hemoglobin if no transfusion is given and transfusion requirement > 2 units of blood in the first 24 hours of admission, were considered rebleeding from portal hypertensive sources.
2 secondary outcomes
Variceal recurrence
Time frame: From date of variceal obliteration until the date of first documented variceal recurrence, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months
All-cause death
Time frame: From date of randomization until the date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
- Derived from this study: PubMed 24955452Wang HM, Lo GH, Chen WC, Chan HH, Tsai WL, Yu HC, Tsay FW, Hsu PI. Randomized controlled trial of monthly versus biweekly endoscopic variceal ligation for the prevention of esophageal variceal rebleeding. J Gastroenterol Hepatol. 2014 Jun;29(6):1229-36. doi: 10.1111/jgh.12538.
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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.
Huay-Min Wang, MD principal investigator
Kaohsiung Veterans General Hospital.
Ping-I Hsu, MD study director
Kaohsiung Veterans General Hospital.
Gin-Ho Lo, MD study director
E-DA Hospital, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wilson-Cook four shooter saeed multi-band ligator in people with Variceal Bleeding, Endoscopic Variceal Ligation, run by Kaohsiung Veterans General Hospital. at 1 site in 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rebleeding (time frame: From date of randomization until the date of first documented rebleeding, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809535, which also lists 1 linked publication.
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 12 Mar 2013.