Monthly Versus Biweekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Condition: Variceal Bleeding, Endoscopic Variceal Ligation
MeSH terms: Hemorrhage
Study type: Interventional

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.
    

Intervention name(s): Wilson-Cook four shooter saeed multi-band ligator; Wilson-Cook four shooter saeed multi-band ligator
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: endoscopic variceal ligation; post-EVL ulcer; variceal bleeding