跳至主要内容
临床试验/CTRI/2024/06/069507
CTRI/2024/06/069507尚未招募不适用

Role of partial splenic embolization combined with endoscopic therapies in cirrhotic patients with hypersplenism having variceal bleed: An observational study.

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
1)To study the recurrence and variceal rebleeding rate in cirrhotic patients with hypersplenism undergoing Partial splenic embolization combined with endoscopic therapies

研究概览

简要总结

This is an observational study. The study will be carried out at the Surgery Department of JIPMER after obtaining Institute’s Ethical committee approval. All patients will be informed about the study and written informed consent will be taken before participation. The patients qualifying the inclusion and exclusion criteria for this study will be recruited for the study. Liver cirrhosis will be diagnosed by an ultrasound evaluation. Baseline blood investigations including haemoglobin, total leukocyte count, platelet count, renal and liver functions will be done. After stabilizing the hemodynamics, the patients will undergo endoscopic examination and endoscopic treatment in the department of Surgery, JIPMER.EVL will be carried out for oesophageal varices at 1 cm above the Z-line in a spirally ascending fashion. After the initial session, EVL will be performed at regular intervals of about 2 weeks till eradication of varices. Eradication of the varices will be defined as no visible varices in endoscopy or the presence of only fibrosed varices not requiring ligation. Partial Splenic Embolization will be performed 1 week after the endoscopic treatment in patients with hypersplenism and thrombocytopenia. These patients will undergo contrast enhanced computed tomography (CECT) scanning to observe the basal status of the spleen. Splenic arteriography will be performed on a digital subtraction angiography (DSA) system via the femoral artery access. Progressive embolization of splenic artery will be performed as the standard of care by repeated injections of a gelatin sponge under the DSA control until a 60–80% reduction in the splenic blood flow is achieved. Broad-spectrum antibiotic prophylaxis will be administered in the peri-intervention period. A post-interventional enhanced CT scan will be  performed to confirm the embolization area 2–3 weeks after the PSE. Patients without hypersplenism (group 2) will undergo endoscopic management alone. A standard dose of NSBB (propranolol) will be given to all patients if there were no contraindications. The primary endpoint of the study will be variceal rebleeding and the secondary endpoints will be severe variceal recurrence and mortality during the 3 month follow-up. In the follow up period blood investigations including haemoglobin, total leukocyte count, platelet count, renal and liver functions will be will be

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •Cirrhotic patients having variceal bleed and portal hypertension with hypersplenism and thrombocytopenia in Group-1 Cirrhotic patients having variceal bleed and portal hypertension without hypersplenism and thrombocytopenia in Group-2.

排除标准

  • •Patients less than 18 years of age and more than 75 years of age Previous therapy (splenectomy, PSE, tissue adhesive injection) to prevent rebleeding Bleeding from isolated gastric or ectopic varices Hepatocellular carcinoma or other malignant tumours Hepatic failure, and Child–Pugh class C with large amount ascites, or grade 3–5 hepatic encephalopathy, or severe coagulopathy Contraindications for PSE Pregnancy and lactation.

结局指标

主要结局

1)To study the recurrence and variceal rebleeding rate in cirrhotic patients with hypersplenism undergoing Partial splenic embolization combined with endoscopic therapies

时间窗: 2 years

2)To study the recurrence and variceal rebleeding rate in cirrhotic patients undergoing endoscopic management alone.

时间窗: 2 years

次要结局

  • To study the incidence of complications in cirrhosis patients with hypersplenism undergoing Partial splenic embolization combined with endoscopic variceal ligation.(2 years)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dhira Shobith Munipati

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

Loading locations...

相似试验