The scientific design of a randomized controlled trial is as follows: Randomized: The researchers decide randomly as to which participants in the trial receive the new treatment and which receive a placebo, or fake treatment. Controlled: The trial uses a control group for comparison or reference.
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What is a transjugular intrahepatic portosystemic shunt (TIPS) procedure?
Originally described by Rösch et al in 1969 as a “radiologic portocaval shunt,” the transjugular intrahepatic portosystemic shunt (TIPS) procedure is a minimally invasive nonsurgical method of achieving portal decompression to treat some of the major complications of portal hypertension.
What are congenital portosystemic shunts (CPSS)?
Congenital portosystemic shunts (CPSS) are rare vascular malformations that create an abnormal connection between portal and systemic veins resulting in complete or partial diversion of the portal flow away from the liver to the systemic venous system. Different anatomic types exist and several clas …
How does a tips shunt work in BCS?
Like a mesoatrial shunt, TIPS provides outflow into the suprahepatic IVC, at a site proximal to a potential intrahepatic stenosis. As patients with BCS are typically hypercoagulable, simultaneous portal vein thrombosis (PVT) may be present; extended TIPS have been described in such cases and have demonstrated success.26
What is a randomized controlled trial (RCT)?
Randomized controlled trials (RCTs) are considered one of the highest level of evidence in clinical practice, due to their strong confidence and robustness in producing data. The “randomization” (e.g., allocating patients randomly in each group of the study) allows eliminating many pre-analytical differences that might bias the entire study.
How is TIPS procedure performed?
During a TIPS procedure, interventional radiologists use image guidance to make a tunnel through the liver to connect the portal vein (the vein that carries blood from the digestive organs to the liver) to one of the hepatic veins (three veins that carry blood away from the liver back to the heart).
What is the indication for surgical treatment with transjugular intrahepatic portosystemic shunt?
Accepted indications for TIPS include the following: Uncontrolled variceal hemorrhage from esophageal, gastric, and intestinal varices that do not respond to endoscopic and medical management. Refractory ascites. Hepatic pleural effusion (hydrothorax)
How long does a Tipss procedure take?
During the Procedure The procedure generally takes 60 to 90 minutes to complete. Numbing medication will be given to the neck, where the catheter is inserted into the jugular vein.
What are indications for TIPS procedure?
Accepted indications for TIPS are: Multiple episodes of variceal bleeding....Absolute contraindications:Primary prevention of variceal hemorrhage.Congestive heart failure.Severe pulmonary hypertension.Severe tricuspid regurgitation.Active biliary obstruction.Sepsis.Multiple hepatic cysts or Caroli's disease.
How is a portosystemic shunt diagnosed?
Ultrasound with Doppler flow analysis. Computed tomography (CT) scan or nuclear scintigraphy which is a nuclear scan that measures blood flow through the liver). Portography which is an X-ray showing the blood vessels supplying and/or bypassing the liver, using radio-opaque dye injected directly into the portal vein.
What is a DIPS procedure?
Direct intrahepatic portosystemic shunt (DIPS) or so called “percutaneous TIPS” involves ultrasound-guided percutaneous simultaneous puncture of the portal vein and inferior vena cava followed by introduction of a guidewire through the portal vein into the inferior vena cava, as a deviation from conventional TIPS.
What is the success rate of TIPS procedure?
According to an older randomized trial, 88% of people with cirrhosis and variceal bleeding who received TIPS survived for 2 years, and 61% survived for at least 5 years. A more recent analysis of TIPS procedures in one hospital found that 78.2% of patients survived longer than 90 days after the procedure.
How much does a TIPS procedure cost?
Median initial costs for TIPS and DSRS were, respec- tively, $ 21,607 and $ 28,734; final costs were, respec- tively, $ 70,527 and $ 48,796 for patients still alive at the end of the 5-year follow-up; corresponding figures for patients dead were $ 74,267 and $ 54,975.
What is portosystemic shunt?
Portosystemic shunts (PSS) are abnormal single or multiple blood vessels which directly join the blood supply from the intestines to the main circulation.
Who is not a candidate for TIPS procedure?
Absolute contraindications to TIPS placement include severe pulmonary hypertension (mean pulmonary pressure > 45 mm Hg), severe tricuspid regurgitation, congestive heart failure, severe liver failure, and polycystic liver disease. Also, no patients with active sepsis should undergo TIPS.
What happens when TIPS procedure fails?
Potential complications of TIPS include acute liver failure, hepatic encephalopathy, hemorrhage, biliary injury, injury to surrounding organs, TIPS thrombosis, TIPS dysfunction, and TIPS migration.
What is the most common complication following TIPS?
ENCEPHALOPATHY. The development of encephalopathy after TIPS is probably the most frequent complication related to the procedure, its incidence ranging between 5 and 35%.
What is a randomized controlled trial?
Randomized controlled trials are the “gold standard” for testing the safety and efficacy of drugs and treatments on the market. Researchers set up a trial to test the effects of a drug on a specific group of people while measuring another for reference. The scientific design of a randomized controlled trial is as follows:
What is the purpose of a control group in a randomized controlled trial?
The purpose of a control group in a randomized controlled trial is to help reduce the likelihood that any benefits or risks that the researchers identify during the trial occur due to factors outside of the experimental treatment. The absence of a control group would mean that the researchers could not attribute any improvement or decline in health ...
Why is randomization important?
Reasons for randomization. Randomization prevents the skewing or deliberate manipulation of results. Both participants and research scientists can influence results unless the researchers assign participants to groups at random. Scientists refer to this skewing of results as selection bias.
Why is randomization important in clinical trials?
Randomization helps to ensure that no bias affects the selection of people for the control group. High-quality clinical trials will publish baseline measurements for both the treatment and control arms of the trial, allowing for direct comparison.
What is a controlled trial?
Controlled: The trial uses a control group for comparison or reference. In the control group, the participants do not receive the new treatment but instead receive a placebo or reference treatment. The United States Food and Drug Administration (FDA) will generally only approve a new treatment as safe and effective for wider use if results indicate ...
Why do scientists assign patients to the group receiving the active treatment?
For example, without randomization, scientists may consciously or subconsciously assign patients to the group receiving the active treatment if they look more likely to benefit from the experimental treatment. This could make a treatment appear more beneficial than it actually is.
What are the limitations of RCT?
The following practical limitations can disrupt the designs for an RCT: 1 Treatments that are more invasive, involving devices or surgery, may be impossible to mock-up realistically in the comparison group. 2 Too few people might have a certain disease and also be available for investigation in both treatment and non-treatment groups. 3 The recruitment of participants to a particular trial may be too difficult.