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

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ClinicalTrials.gov Identifier: NCT01809535
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : March 12, 2013
Sponsor:
Collaborators:
Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
National Yang-Ming University, Kaohsiung, Taiwan, ROC
Information provided by (Responsible Party):
Huay-Min Wang, Kaohsiung Veterans General Hospital.

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.

Condition or disease Intervention/treatment Phase
Variceal Bleeding, Endoscopic Variceal Ligation Device: Wilson-Cook four shooter saeed multi-band ligator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Monthly Versus Biweekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Study Start Date : January 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: The Monthly EVL
Patients in the Monthly group were received EVL at 28-day treatment intervals.
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.

Active Comparator: The Biweekly EVL
Patients in the Biweekly group received repeating EVL every 2 weeks.
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.




Primary Outcome Measures :
  1. Rebleeding [ Time Frame: From date of randomization until the date of first documented rebleeding, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months ]
    Rebleeding from esophageal varices was defined as the presence of hematemesis, melena or both and the bleeding source was identified to be esophageal varices by an emergency endoscopy. Only those who had a clinically significant bleeding, including hematemesis/melena, > 100 ml of fresh blood drained from nasogastric tube, decrease 3 g hemoglobin if no transfusion is given and transfusion requirement > 2 units of blood in the first 24 hours of admission, were considered rebleeding from portal hypertensive sources.


Secondary Outcome Measures :
  1. Variceal recurrence [ Time Frame: From date of variceal obliteration until the date of first documented variceal recurrence, or date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months ]
    After success in variceal obliteration, recurrence of varices was defined as reappearance of esophageal varices or enlargement of previous residual small varices could be injected or ligated at endoscopy. Variceal recurrence was repeatedly treated by EVL using the same protocol in each study cohort.

  2. All-cause death [ Time Frame: From date of randomization until the date of death from any cause, or date of study closure, whichever came first, assessed up to 46 months ]
    Causes of mortality included variceal bleeding, non-variceal bleeding or other causes rather than bleeding.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809535


Locations
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Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 81362
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan, ROC
National Yang-Ming University, Kaohsiung, Taiwan, ROC
Investigators
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Principal Investigator: Huay-Min Wang, MD Kaohsiung Veterans General Hospital.
Study Director: Ping-I Hsu, MD Kaohsiung Veterans General Hospital.
Study Director: Gin-Ho Lo, MD E-DA Hospital, Kaohsiung, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Huay-Min Wang, Department of Internal Medicine, Division of Gastroenterology, Kaohsiung Veterans General Hospital, Kaohsiung, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01809535     History of Changes
Other Study ID Numbers: VGHKS97-CT9-10
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Huay-Min Wang, Kaohsiung Veterans General Hospital.:
endoscopic variceal ligation
post-EVL ulcer
variceal bleeding

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes