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

NCT ID: NCT01809535

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-10-31

Brief 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.

Detailed Description

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.

Conditions

Variceal Bleeding, Endoscopic Variceal Ligation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

The Monthly EVL

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

Group Type: EXPERIMENTAL

Wilson-Cook four shooter saeed multi-band ligator

Intervention Type: DEVICE

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.

Wilson-Cook four shooter saeed multi-band ligator

Intervention Type: DEVICE

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.

The Biweekly EVL

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

Group Type: ACTIVE_COMPARATOR

Wilson-Cook four shooter saeed multi-band ligator

Intervention Type: DEVICE

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.

Wilson-Cook four shooter saeed multi-band ligator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• active or recent hemorrhage from esophageal varices;
• portal hypertension caused by cirrhosis

Exclusion Criteria

• age > 80 or <20 years old
• association with hepatocellular carcinoma or other neoplasms;
• association with cerebral vascular accident, uremia, acute coronary syndrome or other severe illnesses;
• history of gastric variceal bleeding;
• a history of undergoing EIS, EVL, cyanoacrylate injection or prior use of beta blocker;
• a history of prior shunt operation or transjugular intrahepatic portosystemic stent shunt (TIPS);
• deep jaundice (serum bilirubin > 10 mg/dL);
• encephalopathy equal to or greater than stage II;
• failure in control of index variceal bleeding;
• death within 48 h of admission; or
• refusal to participate in the trial.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC

UNKNOWN

Sponsor Role: collaborator

National Yang-Ming University, Kaohsiung, Taiwan, ROC

UNKNOWN

Sponsor Role: collaborator

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role: lead

Responsible Party

Huay-Min Wang

Department of Internal Medicine, Division of Gastroenterology, Kaohsiung Veterans General Hospital, Kaohsiung

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huay-Min Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Ping-I Hsu, MD

Role: STUDY_DIRECTOR

Kaohsiung Veterans General Hospital.

Gin-Ho Lo, MD

Role: STUDY_DIRECTOR

E-DA Hospital, Kaohsiung, Taiwan

Locations

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

Wang HM, Lo GH, Chen WC, Chan HH, Tsai WL, Yu HC, Tsay FW, Hsu PI. Randomized controlled trial of monthly versus biweekly endoscopic variceal ligation for the prevention of esophageal variceal rebleeding. J Gastroenterol Hepatol. 2014 Jun;29(6):1229-36. doi: 10.1111/jgh.12538.

Reference Type: DERIVED

PMID: 24955452 (View on PubMed)

Other Identifiers

VGHKS97-CT9-10

Identifier Type: -

Identifier Source: org_study_id