Completed

A Randomized Controlled Trial of Monthly Versus Biweekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Wilson-Cook four shooter saeed multi-band ligator

+ Wilson-Cook four shooter saeed multi-band ligator

+ Wilson-Cook four shooter saeed multi-band ligator

Device
Who is being recruted

From 20 to 80 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2009
See protocol details

Summary

Principal SponsorKaohsiung Veterans General Hospital.
Last updated: March 12, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

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.

Principal SponsorKaohsiung Veterans General Hospital.
Last updated: March 12, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
active or recent hemorrhage from esophageal varices

portal hypertension caused by cirrhosis

11 exclusion criteria prevent from participating
a history of prior shunt operation or transjugular intrahepatic portosystemic stent shunt (TIPS)

a history of undergoing EIS, EVL, cyanoacrylate injection or prior use of beta blocker

age > 80 or < 20 years old

association with cerebral vascular accident, uremia, acute coronary syndrome or other severe illnesses

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients in the Monthly group were received EVL at 28-day treatment intervals.

Group II

Active Comparator
Patients in the Biweekly group received repeating EVL every 2 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kaohsiung Veterans General Hospital

Kaohsiung City, TaiwanOpen Kaohsiung Veterans General Hospital in Google Maps
CompletedOne Study Center