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Completed

NCT Number: NCT01923064

Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices

The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 0086200032, China

About this study

Gastroesophageal variceal bleeding is known as one of the most frequent death causes of patients with portal hypertension. When a patient has a bleeding episode, if no further prophylactic treatments is given, it's very likely that he/she will develop another rebleeding event in the future and maybe a terminal event. Gastric varices occur in 18-70% of patients with portal hypertension, which appear to be more severe, to require more transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a high rate of rebleeding(38-89%). It has been recommended to use endoscopic cyanoacrylate injection as the first line treatment for hemostasis and secondary prophylaxis for gastric varices by general consensus. However, the efficacy and prevalence of complications between mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been explored and reported. We conducted this study to evaluate the effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis.
  • The age of the patients range from 18 to 80 years old.

Exclusion criteria

  • Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy.
  • Patients who have abnormal portosystemic shunt according to the imaging results.
  • Patients who have no previous upper gastrointestinal bleeding history.
  • Patients who have multiple endoscopic treatments for esophagogastric varices before.

Treatment and study plan

Lipiodol

Drug

endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices

Lauromacrogol

Drug

endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices

Primary outcomes

  1. bleeding rate of the puncture site

    Time frame: time period since the beginning of the injection, until up to 24 hours after the procedure

    We tend to observe the immediate puncture site bleed on the injection of cyanoacrylate and lipiodol or lauromacrogol and withdrawal of needle catheter during endoscopic treatment of gastric varices.

Secondary outcomes

  1. Rebleeding rate after endoscopic treatment

    Time frame: 6 months from the date of enrollment

    Patients were followed up for 6 months to see if they experience relapse of bleeding, presenting melena, haematemesis or both.

Other outcomes

  1. incidence rate of ulcer formation

    Time frame: 2 months after the initial endoscopic treatment

    The patients will be assessed if ulceration is formed on the site of the injection when they have gastroscopy review in 2 months after the initial endoscopic treatment.

  2. eradication rate of gastric varices

    Time frame: 2 months after the initial endoscopic treatment

    Patients will be evaluated if gastric varices are eradicated when they have gastroscopy review in 2 months after the initial endoscopic treatment.

  3. incidence rate of complications

    Time frame: 6 months

    Participants will be followed for up to 6 months starting from the date of enrollment.Complications associated with endoscopic treatments include transient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

A Randomized Study to Compare Effect of Endoscopic Injection of a Mixture of Cyanoacrylate and Lipiodol Versus Cyanoacrylate and Lauromacrogol in Gastric Varices

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2013
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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