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Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices

NCT03729921 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2018-11-05

No results posted yet for this study

Summary

The investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs.

Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.

Conditions

Interventions

PROCEDURE

gastric variceal ligation

The highest point of the variceal vein was used as the primary ligation site. If the input vein was not obvious, the edge of the variceal vein was ligated. The variceal veins were ligated with a 6-ring ligation device, and more than 18 rings rubber bands could be applied in one session. GVL was performed regularly until varices were obliterated or reduced to residual small varices, which could not be ligated. The residual small varices was treated by cyanoacrylate injection.

PROCEDURE

gastric variceal obturation

Gastric varices were uniformly treated via the sandwich technique, which starts with an injection of lauromacrogol, followed by N-butyl cyanoacrylate, then finished with flush of lauromacrogol. The number of injection sites and volume of lauromacrogol and cyanoacrylate used, directly correlated with the size of the varix. Multiple injection sites were chosen in attempt to obliterate the varix or varices in one session. Volume of lauromacrogol used ranged from 2-10ml, while that of cyanoacrylate ranged from 0.5-2ml, per injection site.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-11-30
Completion
2020-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729921 on ClinicalTrials.gov