Role of EUS Guided FNA of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
Palabras clave
Abstracto
Descripción
This is a pilot study that include 30 patients with liver cirrhosis and portal vein thrombus which don't fulfill the criteria of malignancy by imaging technique. The patients involved in the study were and will be admitted to Specialized Medical Hospital, Mansoura University Hospitals.
Study end-points:
• 24 months from the start of the research (cases will be collected over 18 months).
Methods:
Patients will be included in this study will be subjected to the following:
І. The study will be explained to all participants in the study, and an informed written consent will be obtained from them before starting the study.
ІІ. Medical history:
Detailed history was taken with stress on:
- Signs of cachexia (unintentional weight loss, progressive muscle wasting, and a loss of appetite)
- Low grade fever
- Recent onset fatigue
- Abdominal pain
- Dyspepsia
- Hematemesis and melena
- Back ache
ІІІ. Full clinical examination with special stress on:
- Vital signs including: pulse, arterial blood pressure, temperature, respiratory rate.
- Abdominal Lumps and/or tenderness
IV. Laboratory investigations:
Complete blood count, International Normalized Ratio, Liver enzymes, Serum albumin, Serum bilirubin and Serum creatinine.
V. Radiology: Abdominal ultrasound for initial assessment, Abdominal CT (Contrast Enhanced) (Number of HCC nodules if present, diameter of largest HCC nodule in centimeters, nature of PVT, presence of abdominal metastases if present ), Non contrast CT chest to exclude pulmonary metastasis, Bone survey for indicated or complaining cases.
VI. EUS-FNA:
EUS-FNA will be performed in standard fashion. Under EUS guidance, the main, left and right portal veins will be identified. After verifying flow signal by Doppler, a 25-gauge EUS-FNA needle will be advanced from the duodenal bulb or second part of the duodenum into the portal vein, 1-2 passes through portal vein thrombus will be taken to ensure adequate cellularity for histopathology. The puncture site will be monitored under EUS for complications.
Study outcomes:
Histopathology of biopsies taken from bland portal vein thrombus which diagnosed by triphasic CT abdomen to evaluate the possibility of malignant PVT that was not discovered by imaging technique (Abdominal ultrasound and triphasic abdominal CT ).
fechas
Verificado por última vez: | 03/31/2019 |
Primero enviado: | 01/25/2019 |
Inscripción estimada enviada: | 04/01/2019 |
Publicado por primera vez: | 04/03/2019 |
Última actualización enviada: | 04/01/2019 |
Última actualización publicada: | 04/03/2019 |
Fecha de inicio real del estudio: | 05/10/2017 |
Fecha estimada de finalización primaria: | 05/10/2019 |
Fecha estimada de finalización del estudio: | 07/10/2019 |
Condición o enfermedad
Intervención / tratamiento
Procedure: EUS - FNA for benign PVT by imaging
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Experimental: EUS - FNA for benign PVT by imaging Intervention: Procedure/Surgery: EUS guided fine needle aspiration of portal vein thrombus | Procedure: EUS - FNA for benign PVT by imaging endoscopic ultrasound guided fine needle aspiration of portal vein thrombus which did not fulfill criteria of malignancy by imaging technique |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Patients with liver cirrhosis and PVT which don't fulfill criteria of malignancy by triphasic CT abdomen defined as, (neovascularity of thrombus, arterial enhancement with rapid washout, direct invasion by adjacent hepatic mass and diameter of thrombus more than 23 mm), either : - With or without hepatic mass - Undergone local treatment or surgical treatment following a diagnosis of HCC and develop PVT during their follow up. Exclusion Criteria: - Uncooperative or excessively apprehensive patient - Anticoagulation treatment or non-substituted coagulopathy (International Normalized Ratio ≥ 1.5, Platelet count ≤ 50.000 cells/mm3, heparin administration at therapeutic doses). - Inhibition of platelet aggregation by clopidogrel and other thienopyridines. - Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents). - Patients fulfilling criteria of malignancy by triphasic CT on abdomen. - Extra hepatic metastasis of HCC. - Child-Pugh classification stage C. |
Salir
Medidas de resultado primarias
1. Percentage of patients with bland portal vein thrombosis diagnosed by triphasic abdominal CT who are proven to have malignant cells by histopathology obtained via EUS-guided FNA [3 days up to 2 weeks]
2. Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver [2 days]