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Monthly Versus Biweekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding

NCT01809535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-03-12

No results posted yet for this study

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. 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.

Conditions

  • Variceal Bleeding, Endoscopic Variceal Ligation

Interventions

DEVICE

Wilson-Cook four shooter saeed multi-band ligator

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.

DEVICE

Wilson-Cook four shooter saeed multi-band ligator

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.

Sponsors & Collaborators

  • Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC

    collaborator UNKNOWN

  • National Yang-Ming University, Kaohsiung, Taiwan, ROC

    collaborator UNKNOWN

  • Kaohsiung Veterans General Hospital.

    lead OTHER

Principal Investigators

  • Huay-Min Wang, MD · Kaohsiung Veterans General Hospital.

  • Ping-I Hsu, MD · Kaohsiung Veterans General Hospital.

  • Gin-Ho Lo, MD · E-DA Hospital, Kaohsiung, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809535 on ClinicalTrials.gov