A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis

This study has been completed.

Sponsor:

Information provided by:

National Science Council, Taiwan

ClinicalTrials.gov Identifier:

NCT00921349

First received: June 3, 2009

Last updated: June 15, 2009

Last verified: June 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 3, 2009
Last Updated Date	June 15, 2009
Start Date ^ICMJE	December 2004
Primary Completion Date	May 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 15, 2009)	The primary end points of the study were the first episode of variceal bleeding. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00921349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 15, 2009)	The secondary end points were adverse events related to treatment and death of any cause. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
Official Title ^ICMJE	A Randomized, Controlled Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
Brief Summary	The value of banding ligation plus beta blocker in the prophylaxis of first episodes of variceal bleeding has not yet been evaluated. This study was conducted to compare the efficacy and safety of banding ligation plus nadolol versus nadolol in the prophylaxis of first bleeding in cirrhotic patients with high-risk esophageal varices.
Detailed Description	Currently, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of choice for management of bleeding esophageal varices. The advantages of EVL include requiring fewer treatment sessions to achieve variceal obliteration, lower rebleeding rates and fewer complications (5-9). Controlled studies that compared EVL with beta-blocker in the prevention of first variceal bleeding suggested that EVL was at least equal to beta-blockers in the prophylaxis of first variceal bleeding. However, portal pressure may be elevated after repeated EVL. Hence the combination of nadolol and EVL is a reasonable approach to prevent the first episode of variceal bleeding.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Variceal Bleeding Cirrhosis
Intervention ^ICMJE	Procedure: Ligation of varices all varices are ligated until obliteration Drug: Nadolol Nadolol (beta-blocker)
Study Arm (s)	Experimental: Ligation+Nadolol Multi-ligators were applied. Patients received regular ligation treatment at an interval of 3-4 weeks until variceal obliteration. Intervention; ligation of varices plus beta blockers (Nadolol). Interventions: Procedure: Ligation of varices Drug: Nadolol Active Comparator: Nadolol only Intervention: Drug: Nadolol
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	140
Completion Date	May 2009
Primary Completion Date	May 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: the cause of portal hypertension was cirrhosis the degree of esophageal varices was F2 (moderate varices) or more, associated with any of red color signs (red wale markings, cherry red spots or hematocystic spots) no history of hemorrhage from esophageal varices no current treatment with beta-blockers cirrhosis was based on results of liver biopsy, or clinical and biochemical examinations and image studies Exclusion Criteria: age greater than 75 years old or younger than 20 years old association with malignancy, uremia or other serious medical illness which may reduce the life expectancy presence of refractory ascites, hepatic encephalopathy or marked jaundice (serum bilirubin > 10 mg/dl) history of shunt operation, transjugular intrahepatic portosystemic stent shunt or endoscopic therapy (EIS or EVL) had contraindications to beta-blockers, such as asthma, heart failure, complete atrioventricular block, hypotension ( systolic blood pressure < 90 mmHg), pulse rate < 60/ min unable to cooperate
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00921349
Other Study ID Numbers ^ICMJE	EVL+Nadolol
Has Data Monitoring Committee	Yes
Responsible Party	National Science Council
Study Sponsor ^ICMJE	National Science Council, Taiwan
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Science Council, Taiwan
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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