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

NCT01923064 | Completed

• 1 other identifier: chen2013
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Varices; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• bleeding rate of the puncture site

  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.

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

Secondary Outcomes (1)

• Rebleeding rate after endoscopic treatment

  6 months from the date of enrollment

Other Outcomes (3)

• incidence rate of ulcer formation

  2 months after the initial endoscopic treatment

• eradication rate of gastric varices

  2 months after the initial endoscopic treatment

• incidence rate of complications

  6 months

Study Arms (2)

NBCA-lipiodol

ACTIVE COMPARATOR

Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices

Drug: Lipiodol

NBCA-lauromacrogol

EXPERIMENTAL

Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices

Drug: Lauromacrogol

Interventions

Lipiodol DRUG

endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices

NBCA-lipiodol

Lauromacrogol DRUG

endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices

NBCA-lauromacrogol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 0086200032, China

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices; Hypertension, Portal

Interventions

Ethiodized Oil; Polidocanol

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Shiyao Chen, MD

  Zhongshan Hospital, Shanghai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 14, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

CN (1)