MedTrace Logo

EUS-guided Obturation of High Risk Gastric Varices Versus Standard Endoscopic Treatment

NCT04222127 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-01-09

No results posted yet for this study

Summary

Gastric varices occur in patients with portal hypertension, mostly secondary to liver cirrhosis. Although they bleed less frequently than oesophageal varices, gastric variceal bleeding tends to be more severe with reported higher mortality.

Endoscopic variceal obliteration (EVO) by direct endoscopic injection (DEI) using tissue adhesives like glue, CYA or histoacryl demonstrated higher hemostasis and lower bleeding rates compared to band ligation or sclerotherapy. Nevertheless, CYA treatment is known to be associated with significant adverse events like para-variceal injection, hemorrhage from post injection ulcer, needle sticking in the varix, intra-peritoneal injection leading to peritonitis and adherence of the glue to the endoscope, fever, embolization into the renal vein, IVC, pulmonary or systemic vessels.

Endoscopic ultrasound (EUS) offers unique access to abdominal arterial and venous vasculature. This has had the most clinical impact on the treatment of gastroesophageal varices, where EUS may play a role both in the management and can deliver therapy in the form of glue injection, endovascular coil placement or a combination of the two. EUS enables an assessment using Doppler to confirm vessel obliteration after treatment. However, targeting the perforating feeder vessel rather than the varix lumen itself may theoretically minimize the amount of CYA needed to achieve obliteration of GVs and thereby reduce the risk of embolization.

Conditions

  • Gastric Varix

Interventions

OTHER

EUS guided injection of gastric varices by CYA

EUS-guided injection of CYA will be done at entrance of of the varix or the perforator veins when identifiable using a mixture (1:1) of 2-octyl-cyanoacrylate \& lipidol using 19G EUS-FNA needle

OTHER

Direct endoscopic injection of gastric varices by CYA

Direct endoscopic injection of gastric varix by CYA

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Fady S Karam, Master · Mansoura University

  • Ahmed Y Altonbary, MD · Mansoura University

  • Hazim H Almenshawy, Professor · Mansoura University

  • Ayman A Aldosoky, Professor · Mansoura University

  • Seham M Seif, Professor · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-01-01
Completion
2020-06-01

Countries

  • Egypt

Study Locations

More Related Trials

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 NCT04222127 on ClinicalTrials.gov