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

Primary Purpose

Gastric Varices, Portal Hypertension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lipiodol
Lauromacrogol
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Varices

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NBCA-lipiodol

NBCA-lauromacrogol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2013
Last Updated
January 4, 2016
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01923064
Brief Title
Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices
Official Title
A Randomized Study to Compare Effect of Endoscopic Injection of a Mixture of Cyanoacrylate and Lipiodol Versus Cyanoacrylate and Lauromacrogol in Gastric Varices
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varices, Portal Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NBCA-lipiodol
Arm Type
Active Comparator
Arm Description
Patients will receive injection of a mixture of cyanoacrylate and lipiodol to treat gastric varices
Arm Title
NBCA-lauromacrogol
Arm Type
Experimental
Arm Description
Patients will receive injection of the mixture of cyanoacrylate and lauromacrogol to treat gastric varices
Intervention Type
Drug
Intervention Name(s)
Lipiodol
Intervention Description
endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices
Intervention Type
Drug
Intervention Name(s)
Lauromacrogol
Intervention Description
endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices
Primary Outcome Measure Information:
Title
bleeding rate of the puncture site
Description
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 Frame
time period since the beginning of the injection, until up to 24 hours after the procedure
Secondary Outcome Measure Information:
Title
Rebleeding rate after endoscopic treatment
Description
Patients were followed up for 6 months to see if they experience relapse of bleeding, presenting melena, haematemesis or both.
Time Frame
6 months from the date of enrollment
Other Pre-specified Outcome Measures:
Title
incidence rate of ulcer formation
Description
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.
Time Frame
2 months after the initial endoscopic treatment
Title
eradication rate of gastric varices
Description
Patients will be evaluated if gastric varices are eradicated when they have gastroscopy review in 2 months after the initial endoscopic treatment.
Time Frame
2 months after the initial endoscopic treatment
Title
incidence rate of complications
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, MD
Organizational Affiliation
Zhongshan Hospital, Shanghai
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
0086200032
Country
China

12. IPD Sharing Statement

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

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