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Time Interval for Endoscopic Variceal Ligation

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ClinicalTrials.gov Identifier: NCT01291277
Recruitment Status : Completed
First Posted : February 8, 2011
Results First Posted : December 26, 2016
Last Update Posted : February 13, 2017
Sponsor:
Collaborators:
Yale University
VA Connecticut Healthcare System
Information provided by (Responsible Party):
Loren Laine, University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Variceal Bleeding
Intervention Device: Endoscopic Variceal Ligation
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ligation: 1-week Interval Ligation 2-week Interval
Hide Arm/Group Description

Endoscopic variceal ligation performed at 1-week intervals

Endoscopic Variceal Ligation: Ligation of esophageal varices

Endoscopic variceal ligation performed at 2-week intervals

Endoscopic Variceal Ligation: Ligation of esophageal varices

Period Title: Overall Study
Started 45 45
Completed 40 42
Not Completed 5 3
Reason Not Completed
Death             2             2
Lost to Follow-up             3             1
Arm/Group Title Ligation: 1-week Interval Ligation 2-week Interval Total
Hide Arm/Group Description

Endoscopic variceal ligation performed at 1-week intervals

Endoscopic Variceal Ligation: Ligation of esophageal varices

Endoscopic variceal ligation performed at 2-week intervals

Endoscopic Variceal Ligation: Ligation of esophageal varices

Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
53
(27 to 66)
54
(30 to 78)
54
(27 to 78)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
14
  31.1%
7
  15.6%
21
  23.3%
Male
31
  68.9%
38
  84.4%
69
  76.7%
1.Primary Outcome
Title Proportion of Patients With Eradication of Esophageal Varices
Hide Description [Not Specified]
Time Frame At 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ligation: 1-week Interval Ligation 2-week Interval
Hide Arm/Group Description:

Endoscopic variceal ligation performed at 1-week intervals

Endoscopic Variceal Ligation: Ligation of esophageal varices

Endoscopic variceal ligation performed at 2-week intervals

Endoscopic Variceal Ligation: Ligation of esophageal varices

Overall Number of Participants Analyzed 45 45
Measure Type: Count of Participants
Unit of Measure: Participants
37
  82.2%
23
  51.1%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ligation: 1-week Interval Ligation 2-week Interval
Hide Arm/Group Description

Endoscopic variceal ligation performed at 1-week intervals

Endoscopic Variceal Ligation: Ligation of esophageal varices

Endoscopic variceal ligation performed at 2-week intervals

Endoscopic Variceal Ligation: Ligation of esophageal varices

All-Cause Mortality
Ligation: 1-week Interval Ligation 2-week Interval
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ligation: 1-week Interval Ligation 2-week Interval
Affected / at Risk (%) Affected / at Risk (%)
Total   16/45 (35.56%)   15/45 (33.33%) 
General disorders     
Hospitalization  [1]  16/45 (35.56%)  15/45 (33.33%) 
Indicates events were collected by systematic assessment
[1]
Per the study design, this predefined outcome that we collected and reported was the serious adverse event of hospitalization (not specific etiologies).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ligation: 1-week Interval Ligation 2-week Interval
Affected / at Risk (%) Affected / at Risk (%)
Total   4/45 (8.89%)   1/45 (2.22%) 
Gastrointestinal disorders     
Esophageal  [1]  4/45 (8.89%)  1/45 (2.22%) 
Indicates events were collected by systematic assessment
[1]
This predefined outcome included any of the esophageal symptoms of dysphagia, odynophagia, and/or chest pain (a composite endpoint).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Loren Laine
Organization: Yale School of Medicine
Phone: 203-937-3462
Responsible Party: Loren Laine, University of Southern California
ClinicalTrials.gov Identifier: NCT01291277     History of Changes
Other Study ID Numbers: HS-08-00172
First Submitted: February 4, 2011
First Posted: February 8, 2011
Results First Submitted: October 25, 2016
Results First Posted: December 26, 2016
Last Update Posted: February 13, 2017