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Ascites clinical trials

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NCT ID: NCT03191851 Completed - Ascites Hepatic Clinical Trials

Evaluation of 'Melody' Paracentesis Device for Ascites Therapy

EMPATHY
Start date: January 4, 2016
Phase: N/A
Study type: Interventional

Ascites is the accumulation of fluid inside the abdomen. This can happen when the liver fails due to a substantial amount of scarring (cirrhosis). Patients (pts) must have this fluid drained and as cirrhosis progresses, patients will require drainage of ascites repeatedly on a regular basis, leading to frequent hospitals visits and increased complications. The current drainage device is slow and doesn't always drain completely so pts have to return repeatedly to keep symptoms under control. A new device (called Melody) has been developed and specifically designed for the purpose of draining ascites fluid, which the Investigators expect to drain faster and completely. This study will compare the volume of ascites drained using the new 'Melody' catheter device with that used in standard NHS practice. If the melody catheter device is confirmed as superior to the current device this would improve patient experience (less frequent visits to hospital and increased length of time between visits). With fewer procedures performed per patient, the pressure on the NHS would be greatly reduced in terms of time and costs.

NCT ID: NCT03189108 Completed - Cancer Clinical Trials

Collection of Malignant Ascites, Pleural Fluid, and Blood From People With Solid Tumors

Start date: May 22, 2017
Phase:
Study type: Observational

Background: Researchers want to study fluids and blood of people with cancer. The fluids are from the abdomen and around the lungs. Studying these might help researchers learn about the biology of cancer. This may lead to better ways to treat cancer. Objectives: To study the biology of cancer. Eligibility: Adults 18 and older with malignant solid tumors. Design: Participants will be screened with medical history, blood tests, and confirmation of diagnosis. Participants will have samples taken at regularly scheduled procedures. Fluids from the abdomen and/or lungs will be taken as part of the procedures. Blood will be taken separately. Participants may be asked to give more samples at future procedures. ...

NCT ID: NCT03107091 Completed - Cirrhosis Clinical Trials

Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

Start date: July 15, 2017
Phase: Phase 2
Study type: Interventional

Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.

NCT ID: NCT03069131 Completed - Cirrhosis Clinical Trials

Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites

ProPILARifax
Start date: March 20, 2018
Phase: Phase 3
Study type: Interventional

We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in 'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month survival.

NCT ID: NCT02996188 Completed - Liver Cirrhosis Clinical Trials

Acute Hemodynamic Changes During Paracentesis

Start date: June 2012
Phase: N/A
Study type: Observational

The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense ascites using non-invasive inert gas rebreathing.

NCT ID: NCT02975726 Completed - Liver Cirrhosis Clinical Trials

Peritoneal Dialysis Catheters for the Treatment of Refractory Ascites

Start date: January 2017
Phase: N/A
Study type: Interventional

One complication of liver disease is the buildup of fluid within the belly. This is known as ascites. Patients who have ascites have a decreased appetite, pain, nausea and shortness of breath. Ascites is typically treated with medications, however when that does not work, patients need a procedure where a needle is inserted in the belly every few weeks to drain the excess fluid. About 2 in 5 patients with ascites from liver failure can get kidney disease from their worsening liver function or from the drainage of fluid with needles. Once patients have both advanced liver disease and kidney disease, their chance of dying largely increases. The present study will be the first of its kind to study a new technique to treat ascites. Investigators are planning to place a tube in a patient's belly to drain the excessive amounts of fluid. This technique is similar to how one type of dialysis is done to treat patients with kidney failure. This study is set as a pilot investigation in order to determine the feasibility of doing a larger, randomized clinical trial investigating the use of this novel technique. Importantly, advanced liver disease patients are at high risk to develop kidney disease, and therefore are an important group to focus on. Investigators believe that this technique will prevent or slow the development of kidney disease in liver failure patients, and improve their quality of life, far more than the current available treatments.

NCT ID: NCT02891369 Completed - Clinical trials for Refractory Malignant Ascites

Analysis of Patients Treated With Bevacizumab Intraperitoneal for the Treatment of Refractory Malignant Ascites

BEVASCITE
Start date: February 2015
Phase:
Study type: Observational

The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care. Conventional treatment is based on paracentesis of ascites. The progression of the disease leads to increased production of ascites requiring more frequent paracentesis. Main therapeutic alternatives are constituted by the controversial use of diuretics and the use of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF): bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the treatment of refractory malignant ascites showed no sufficient clinical benefit. VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and capillary filtration surface generating increased protein extravasation. These phenomena are responsible for an increase of the volume of ascites product. Thus the use of inhibitors of VEGF, such as bevacizumab, could reduce the production of ascites. The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on small animals in intraperitoneal administration. Studies in humans are few and the doses used are not consistent from one study to another.

NCT ID: NCT02867293 Completed - Massive Ascites Clinical Trials

Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.

AscitesLDLT
Start date: January 2013
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02821377 Completed - Cirrhosis Clinical Trials

Metabolic Effects of Furosemide +HSS in Refractory Ascites

Start date: December 2013
Phase: Phase 2
Study type: Interventional

Introduction: Patients with chronic liver diseases are usually thin as a result of hypermetabolism and malnutrition expressed by reduced levels of leptin and impairment of other adyponectins such as visfatin. Aims: To evaluate the metabolic and inflammatory effects of intravenous high-dose furosemide plus hypertonic saline solutions (HSS) compared with repeated paracentesis and a standard oral diuretic schedule, in patients with cirrhosis and refractory ascites. Methods; All consecutive cirrhotic patients with refractory ascites unresponsive to outpatient treatment will be enrolled . Enrolled subjects will be randomized to treatment with intravenous infusion of furosemide (125-250mg⁄bid) plus small volumes of HSS from the first day after admission until 3 days before discharge (Group A ), or repeated paracentesis from the first day after admission until 3 days before discharge (Group B, ). Plasma levels of ANP, BNP, Leptin, visfatin, IL-1β, TNF-a, IL-6 were measured before and after the two type of treatment.

NCT ID: NCT02799212 Completed - Clinical trials for Hepatocellular Carcinoma

Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma

SOMAPROTECT01
Start date: January 10, 2018
Phase: Phase 3
Study type: Interventional

Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.