Active clinical trials for "Ascites"

The purpose of this study is to compare the efficacy of S1 plus paclitaxel (intravenous injection & intraperitoneal injection) plus bevacizumab (intraperitoneal injection) vs. S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites.

Ascites in liver cirrhosis is explained by increased production of vasoactive substances leading to renal vasoconstriction and salt and water retention. The retained water then accumulates in the peritoneal cavity under the effect of portal hypertension and low albumin. Refractory ascites is defined as ascites that cannot be mobilized or prevented from early recurrence after large-volume paracentesis despite medical therapy and dietary sodium restriction. Midodrine is an α1 receptor agonist that can improve systemic and renal hemodynamics in non-azotemic cirrhotic patients by counteracting mesenteric vasodilatation, which is accentuated in cirrhosis.

Malignant pleural effusion and/ or malignant ascites is generally defined by presence of malignant cells in the effusion fluid. The first-line therapies are mostly intrusive, medically demanding and inefficient, and therefore, it is important to study and develop new therapeutic option to address the unmet need. This protocol for BSG-001 is developed for the treatment of malignant pleural effusion and/ or malignant ascites. BSG-001 is an immune-modulator primarily exerts its effect via Toll-like receptor. The purpose of this study is to assess the safety and tolerability of BSG-001. All eligible subjects will receive BSG-001 for at least 12 weeks (3 cycles).

The cumulative risk of refractory ascites is in the order of 20% within five years of the development of ascites. An elevated sinusoidal pressure is essential for the development of ascites, as fluid accumulation does not develop at portal pressure gradient below 8 mm Hg, and rising corrected sinusoidal pressure correlates with decreased 24-hour urinary excretion of sodium.More recently, it has been hypothesised that bacterial translocation associated with portal hypertension in cirrhosis and related pathogen-associated, molecular pattern activated innate immune responses lead to systemic inflammation.This is associated with vasodilatation as well as release of proinflammatory cytokines, reactive oxygen and nitrogen species, contributing to organ dysfunction.This activates sympathetic nervous system stimulating reabsorption of sodium in proximal,distal tubules, loop of Henle and collecting duct as well as the renin-angiotensin-aldosterone system, leading to sodium absorption from distal tubule and collecting duct.[5]Renal sodium retention and eventual free water clearance due to non-osmoticrelease of arginine-vasopressin and its action on V2 receptor in the collectingduct underlie the fluid retention associated with oedema and ascites in cirrhosis.The lowering of portal pressure using non selective beta blocker has also been shown to reduce the development of ascites, refractory ascites and hepatorenal syndrome.Furthermore, the effect of non slective beta blocker on intestinal permeability, bacterial translocation and inflammatory response has been proposed to mitigate the risk of developing spontaneous bacterial peritonitis.

Transjugular intrahepatic portosystemic shunt (TIPS) could effectively decrease portal hypertension-related complications. This study intends to evaluate the efficacy and safety of TIPS combined with subsequent microwave ablation in HCC patients with refractory ascites.

The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. The project will be conducted at ILBS between April 2020 and March 2021. The concept of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives. The expected outcomes are Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis after a short duration (5day) intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in comparison to a single large volume paracentesis in the next 3 months. Secondary outcome: 1. Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D, 60 D and 90 D follow up, to assess between the groups Need for repeated paracentesis : Number assessed AKI : Improvement or worsening of renal functions Hepatic encephalopathy: Grading as per West Haven Classification Hyponatremia Diuretic tolerability : Dose and duration tolerated Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm Transplant free survival Risk of procedure related complications Changes in MELD or CTP between the groups ( Improvement vs worsening ) Need for hospitalization between the groups

This is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. The secondary objectives are the following: To evaluate the efficacy of treatment for handling ascites, associated with changes in the body weight of patients and their requirements for evacuation paracentesis during follow-up. To investigate the effects of treatment on bacterial translocation, by means of determining bacterial DNA. To determine the incidence of complications associated with treatment in the course of follow-up. To evaluate the effect of treatment on quality of life of the patients treated, evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease questionnaire).

Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.

All consecutive patients with cirrhosis of liver who satisfy the criteria will be included and will be evaluated clinically along with all routine investigations and standard medical therapy will be continued among these patients. The patients between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan & imaging.) , with ascites and HVPG (Hepatic Venous Pressure Gradient) >12, with 2 or more large volume paracentesis in last 3 month . CTP ≥ 7-13 will be considered for the study. At baseline, a complete history of the cause of cirrhosis of liver with clinical and physical examination, a record of demographic profile, standard of care biochemical investigations would be done. In this study patients who satisfy the inclusion and exclusion criteria as mentioned below will be enrolled to receive either standard medical therapy with Large volume paracentesis and albumin infusion or to be randomised to receive TIPS (Transjugular Intrahepatic Portosystemic Shunt). The patients in group A will be given standard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required Large Volume Paracentesis (LVP) and albumin infusion and diuretics.

The aim of this study is to evaluate difference in the rate of recovery of intestinal motility according to different ascites replacement strategy after living donor liver transplantation.