Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06881082

Cross-section Band Ligation Versus Stepladder Band Ligation Techniques in Prophylaxis of Esophageal Varices in Cirrhotic Liver Disease A Randomized Controlled Trial

Led by Tanta University · Updated on 2025-03-18

320

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two different techniques of endoscopic band ligation, the cross-section and stepladder methods, for preventing esophageal varices in patients with cirrhosis who have medium to large varices. This randomized controlled trial aims to compare these techniques by looking at their effectiveness, side effects, variceal recurrence, and survival rates. The study is sponsored by Tanta University and involves adult participants aged 18 and older with liver cirrhosis and confirmed esophageal varices. Participants will be randomly assigned to receive endoscopic band ligation using either the cross-section technique or the stepladder technique. Treatment sessions will take place every two to four weeks until the varices are eradicated. After eradication, follow-up endoscopies will be performed between 3 to 6 months to check for recurrence of varices. The study includes a follow-up period of 6 months with clinic visits every 3 months to assess side effects, bleeding rates, and mortality related to the band ligation treatments. During the study, participants will undergo initial assessments including medical history, clinical examination, laboratory tests, and upper endoscopy to determine variceal status. Regular monitoring visits will include laboratory testing and evaluation for treatment side effects and complications. The primary outcomes measured are variceal bleeding rate, mortality rate, and banding side effects at 6 weeks, with secondary outcomes including variceal obliteration and recurrence at 6 months. The total study duration is approximately one year, with careful observation to evaluate the comparative benefits and risks of each ligation method.

CONDITIONS

Brief Title

Cross-section Band Ligation Versus Stepladder Band Ligation of Esophageal Varices

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged >18 years
  • Cirrhotic patients
  • Endoscopic evidence of medium or large-sized esophageal varices
Not Eligible

You will not qualify if you...

  • History of variceal bleeding or previous primary prevention of varices
  • Portal vein thrombosis or previous porto-systemic shunts like TIPS
  • Current use of drugs affecting portal pressure such as beta blockers or nitrates
  • Advanced cardiovascular diseases including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, and severe bradycardia
  • Severe respiratory diseases such as COPD or bronchial asthma
  • Uncontrolled diabetes mellitus
  • Renal impairment
  • Hepatocellular carcinoma
  • Allergy to carvedilol
  • Pregnancy or lactation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated every 2 to 4 weeks until eradication

Participants undergo endoscopic band ligation using either the cross-section or stepladder technique. The band ligation is repeated every two to four weeks until the varices are eradicated.

Multiple visits every 2 to 4 weeks until variceal eradication

Follow-up

Duration - 3 to 6 months after eradication

After eradication of varices, participants have repeat endoscopy after 3 to 6 months to check for variceal recurrence, evaluate treatment-related side effects, bleeding rates, and mortality.

1 to 2 visits for follow-up endoscopy and assessments

Trial Site Locations

Total: 1 location

1

Tanta University Hospitals

Tanta, Gharbyea, Egypt, 31516

Actively Recruiting

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Research Team

R

Rania M Elkafoury, MD

N

Nabila A Elgazzar, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NA

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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