NCT03753438已完成不适用
Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics-An Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in weight from baseline
研究概览
简要总结
The study will be conducted in department of Hepatology at ILBS, the patients will be recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for standard of care and also patients who undergo IGB placement as part of weight reduction policy in these group of patients and will undergo an UGI endoscopy followed by placement of intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients between 18 and 65 years
- •NASH (Non Alcoholic SteatoHepatitis) cirrhosis
- •BMI > 30 and failure to control weight despite full dietary and life style modifications.
- •Compensated : CTP 6 & 7 without any evidence of decompensation in form of Hepatic encephalopathy, ascites, GI bleed or prolonged jaundice.
- •Small varices: Grade I varices
排除标准
- •Alcoholic liver disease
- •Advanced liver disease with ascites, hepatic encephalopathy
- •Other liver diseases such as chronic hepatitis B, chronic hepatitis C, Wilsons' disease, Hemochromatosis, glycogen storage diseases etc.
- •Pregnancy
- •Unwilling patients
- •Large varices
- •Past h/o GI bleed
- •Hiatus hernia
- •Gastric ulcer
- •Severe esophagitis (Grade B and above)
- •Severe PHG or gastric erythema
结局指标
主要结局
Change in weight from baseline
时间窗: 3 months
Change in weight reduction from baseline
时间窗: 6 Months
次要结局
- Change in hormonal levels such as leptin level in both groups.(3 Months)
- Change in hormonal levels such as Adiponectin level in both groups..(3 Months)
- Improvement in liver parameters such as serum albumin in both groups.(6 Months)
- Change in development of liver related complications(6 Months)
- Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).(6 Months)
- Improvement of insulin resistance in both groups.(6 Months)
- Decreased usage of medications for diabetes mellitus in both groups.(6 Months)
- Improvement liver parameters such as INR in both groups(3 Months)
- Improvement in liver parameters such as bilirubin in both groups.(6 Months)
- Change in hormonal levels such as Endothelin level in both groups..(6 Month)
- Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.(6 Months)
- Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.(6 Months)
- Disappearance of esophageal varices in both groups.(6 Months)
- Improvement in liver parameters such as INR in both groups.(6 Months)
- Improvement in liver parameters such as bilirubin in both groups(3 Months)
- Improvement in LSM (liver stiffness on fibroscan) in both groups(3 Months)
- Improvement in LSM (liver stiffness on fibroscan) in both groups.(6 Months)
- Improvement in CAP (Controlled Attenuation Index) in both groups.(6 Months)
- Improvement in liver histology post completion of study in both groups.(6 Months)
- Change in hormonal levels such as Adiponectin level in both groups.(6 months)
- Change in hormonal levels such as Ghrelin level in both groups..(6 Months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)Non Alcoholic SteatohepatitisNCT01761370National University Hospital, Singapore21
招募中
不适用
Intragastric Balloon in Obese Patients With Uncontrolled AsthmaObesityAsthmaNCT05364957University Hospital, Toulouse84
进行中（未招募）
不适用
Effectiveness of Intragastric balloon associated with diet on treatment of patients with type 2 diabetesutritional and metabolic diseasesObesityDiabetes Mellitus, Type 2C18.654.726.500C18.452.394.750.149RBR-3ypfxvFaculdade de Medicina da Univesidade de São Paulo
已完成
不适用
ReShape Intragastric Balloon for the Treatment of ObesityObesityNCT01024465ReShape Lifesciences26
已完成
不适用
Prospective trial to measurement of intragastric pressureJPRN-UMIN000035500Tobata Kyoritsu Hospital50