Trial Outcomes & Findings for Time Interval for Endoscopic Variceal Ligation (NCT NCT01291277)

NCT ID: NCT01291277

Last Updated: 2017-02-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 90 participants
• Primary outcome timeframe: At 4 weeks
• Results posted on: 2017-02-13

Participant Flow

Participant milestones

Measure	Ligation: 1-week Interval Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices	Ligation 2-week Interval Endoscopic variceal ligation performed at 2-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices
Overall Study STARTED	45	45
Overall Study COMPLETED	40	42
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	Ligation: 1-week Interval Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices	Ligation 2-week Interval Endoscopic variceal ligation performed at 2-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices
Overall Study Death	2	2
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

Time Interval for Endoscopic Variceal Ligation

Baseline characteristics by cohort

Measure	Ligation: 1-week Interval n=45 Participants Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices	Ligation 2-week Interval n=45 Participants Endoscopic variceal ligation performed at 2-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices	Total n=90 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	54 years n=7 Participants	54 years n=5 Participants
Gender Female	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Gender Male	31 Participants n=5 Participants	38 Participants n=7 Participants	69 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 4 weeks

Outcome measures

Measure	Ligation: 1-week Interval n=45 Participants Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices	Ligation 2-week Interval n=45 Participants Endoscopic variceal ligation performed at 2-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices
Proportion of Patients With Eradication of Esophageal Varices	37 Participants	23 Participants

Adverse Events

Ligation: 1-week Interval

Serious events: 16 serious events

Other events: 4 other events

Deaths: 0 deaths

Ligation 2-week Interval

Serious events: 15 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ligation: 1-week Interval n=45 participants at risk Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices	Ligation 2-week Interval n=45 participants at risk Endoscopic variceal ligation performed at 2-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices
General disorders Hospitalization	35.6% 16/45	33.3% 15/45

Other adverse events

Measure	Ligation: 1-week Interval n=45 participants at risk Endoscopic variceal ligation performed at 1-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices	Ligation 2-week Interval n=45 participants at risk Endoscopic variceal ligation performed at 2-week intervals Endoscopic Variceal Ligation: Ligation of esophageal varices
Gastrointestinal disorders Esophageal	8.9% 4/45	2.2% 1/45

Additional Information

Dr. Loren Laine

Yale School of Medicine

Phone: 203-937-3462

Email: loren.laine@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place