Non-neoplastic bile duct disorder

This study compares two treatments for acute cholecystitis (inflamed gallbladder) in patients aged 75 and older. One is the standard laparoscopic surgery to remove the gallbladder. The other is a newer, less invasive procedure called EUS-guided gallbladder drainage, where a small…

This Phase 3 study tests whether the drug elafibranor can slow liver damage in adults with primary sclerosing cholangitis (PSC), a rare disease that scars the bile ducts. About 350 participants will receive either elafibranor or a placebo daily for several years. The main goal is…

This Phase 3 trial tests whether adding the experimental drug Rina-S to standard care (bevacizumab or monitoring) can help keep platinum-sensitive ovarian cancer from returning after chemotherapy. About 528 participants will receive either Rina-S alone, Rina-S plus bevacizumab, b…

This study tests whether biodegradable stents can safely open narrowed bile ducts in 20 people with primary sclerosing cholangitis (PSC). The stents are placed during an endoscopic procedure and dissolve over time, aiming to improve symptoms like itching and fatigue and prevent t…

This early-stage trial is testing whether a transplant of healthy gut bacteria can be safely given to people with primary sclerosing cholangitis (PSC), a rare liver disease. Twenty-eight adults will first take antibiotics to clear their gut, then receive capsules containing freez…

This study tests whether giving oral antibiotics after Kasai surgery can prevent cholangitis, a serious bile duct infection, in infants with biliary atresia. About 356 babies will be randomly assigned to receive either preventive antibiotics or standard care, and they will be fol…

This study tests whether transplanting healthy stool bacteria (FMT) can improve liver health in people with primary sclerosing cholangitis (PSC) and inflammatory bowel disease. 58 adults will receive either FMT or a placebo via colonoscopy and enemas. The main goal is to see if F…

This study compares two endoscopic procedures to drain an infected gallbladder in people who are too frail or ill for surgery. About 90 participants will be randomly assigned to one of two drainage methods using a scope. The goal is to see which approach works better and causes f…

This study tests whether draining the gallbladder using a thin tube passed through the mouth (EUS-GBD) right away is better than starting with antibiotics alone for elderly or very sick patients with mild to moderate gallbladder infection who cannot have surgery. About 110 partic…

This early-stage study tests whether the experimental drug TAK-781 is safe and tolerable in healthy volunteers and in people with primary sclerosing cholangitis (PSC), a chronic liver disease. The study also looks at how the body processes the drug. About 134 participants will be…

This study tests whether giving an antibiotic (gentamicin) directly into the bile duct during a procedure called ERCP helps people with acute cholangitis recover faster. About 172 adults with mild to moderate infection will be randomly assigned to receive either the extra antibio…

This study is testing whether a specific diet can help people pass very small gallstones (sludge) without surgery. One hundred adults with tiny stones (less than 2 mm) will be randomly assigned to a special diet or a control diet. The main goal is to see if the diet can completel…

This study tests whether a high-MCT (medium-chain triglyceride) formula given before and after Kasai surgery can improve growth and nutrition in infants with biliary atresia. Biliary atresia is a rare liver condition that blocks bile flow, leading to malnutrition. The trial will …

This study compares placing one versus two small stents in the gallbladder to prevent repeat symptoms like pain and infection in people who cannot have their gallbladder removed. About 30 adults will be randomly assigned to get one or two stents during an endoscopic procedure. Re…

This early study tests whether siplizumab, given at the time of liver transplant, can safely prevent the immune system from attacking the new liver. Up to 8 adults with autoimmune hepatitis or primary sclerosing cholangitis will receive two doses. The main goal is to check for se…

This Phase 2 trial tests whether the drug BRS201 (a form of vitamin B12) can improve liver health in people with primary sclerosing cholangitis (PSC), a rare liver disease. Over 8 weeks, 28 participants will take either the drug or a placebo for 4 weeks each, in random order. The…

This study tests a new drug, LB-P8, in 87 adults with primary sclerosing cholangitis (PSC), a rare liver disease. The goal is to see if LB-P8 is safe and can lower levels of alkaline phosphatase (ALP), a marker of liver damage. Participants will receive either LB-P8 or a placebo,…

This study looks at 64 adults with moderate to severe gallbladder inflammation who had a drainage tube placed. It compares removing the gallbladder early (during the same hospital stay) versus waiting over 6 weeks. The goal is to see which timing leads to fewer complications and …

This study tests a new, faster MRI scan for the abdomen and pelvis that uses artificial intelligence to create clear images. About 300 adults who need an MRI as part of their care will get both the standard scan and the fast version. The goal is to see if the fast scan is just as…

This study tests whether a fluorescent dye called indocyanine green (ICG) can help diagnose biliary atresia, a rare liver disease in infants where bile ducts are blocked. After injection, the dye is normally removed through bile and appears in stool. In infants with biliary atres…

This study tests a simple method to diagnose biliary atresia, a serious liver condition in newborns. Infants with suspected cholestasis receive a dye called indocyanine green (ICG) through an IV. Doctors then check the baby's diaper for the dye, which would indicate bile is flowi…

This study compares two methods of removing the gallbladder during laparoscopic (keyhole) surgery: through a port near the belly button or one below the breastbone. The goal is to see which approach causes less pain and fewer wound problems like infection. The trial will involve …

This study compares two types of sedation used during a procedure to drain blocked bile ducts. About 98 adults will receive either propofol-remifentanil or propofol-ketamine. The goal is to see which method leads to faster recovery, better comfort, and fewer side effects, especia…

This study tests a new tablet called 4-MUST to see if it reduces pain and discomfort in people with chronic gallbladder inflammation and bile duct issues. About 300 adults aged 18-70 will receive either the drug or a placebo for 29 days. The main goal is to measure pain relief us…

This study tests an experimental drug called volixibat for people with primary biliary cholangitis (PBC) who suffer from severe itching. The trial will involve 260 adults and compare volixibat against a placebo to see if it safely reduces itch severity and improves quality of lif…

This study compares two ultrasound-guided nerve blocks to control pain after laparoscopic gallbladder removal. Seventy adults will receive either a modified thoracoabdominal nerve block or a recto-intercostal fascial plane block. The goal is to see which block reduces the need fo…

This study compares two ways to manage pain after laparoscopic gallbladder removal. One group gets standard local anesthesia at the incision sites, while the other also receives a nerve block guided by the surgery camera. The goal is to see if the added block reduces pain and the…

This study at the National Institutes of Health is looking at 1,000 adults with known or suspected hormone gland (endocrine) disorders. The goal is to better understand these conditions and help train doctors. Participants may receive tests, treatments, or surgery as part of thei…

This study is gathering health information from 2,000 adults with primary sclerosing cholangitis (PSC) to build a real-world data comparator group. The goal is to help design and run future drug trials more efficiently by providing a control group from real patient experiences. P…

This study enrolls up to 15,000 children with known or suspected endocrine or metabolic disorders, along with their family members. Researchers will collect medical records, blood, saliva, and other samples to identify genetic changes linked to these conditions. The goal is to be…

This study looks at medical records of 514 adults in India with acute cholangitis (a bile duct infection and blockage) who had a drainage procedure. The goal is to create a new composite index that combines factors like death, need for organ support, ICU stay, complications, hosp…

This study looks at liver inflammation (hepatitis) that can occur in cancer patients treated with immune checkpoint inhibitors, a type of immunotherapy. Researchers aim to describe the different patterns of liver injury and how they respond to treatment. By collecting real-world …

This study aims to collect medical data and biological samples (blood, urine, stool, and tissue) from up to 4,000 adults with known or suspected gastrointestinal diseases. Participants receive standard medical care at the NIH, and any extra samples or leftover tissue from procedu…

This early-stage study is testing a new tablet called 4-MUST in 45 healthy volunteers. Researchers want to see if taking the drug with food changes how much gets into the blood, and how safe and tolerable it is after single and repeated doses. The results will help design future …

This study aims to understand what causes primary sclerosing cholangitis (PSC), a rare chronic liver disease. About 143 adults with PSC will provide blood, saliva, urine, stool, and tissue samples, plus undergo imaging and procedures like colonoscopy and liver biopsy. No treatmen…

This study is creating a central database and tissue bank for rare diseases affecting the kidneys and liver, such as ARPKD and Joubert syndrome. Researchers will collect medical information, genetic samples, and tissues from 200 participants to help doctors and scientists better …

This study looks at whether using lung ultrasound right after gallbladder surgery can find breathing problems like collapsed lung tissue (atelectasis) early. About 110 adults having laparoscopic gallbladder removal with low-flow anesthesia will be checked. The goal is to see if e…

This study is creating a large database of information and samples from 1,000 infants with cholestasis, a condition that causes prolonged jaundice. The goal is to better understand diseases like biliary atresia and find ways to improve care. Researchers will track how the disease…

This study follows 1,000 children with primary sclerosing cholangitis (PSC), a rare liver disease that damages bile ducts. Researchers will collect medical data, DNA, and symptom reports over time to understand how the disease progresses and affects daily life. The goal is to ide…

This study is collecting medical information, genetic material, and body fluid samples from over 1,200 children with biliary atresia, a rare liver disease. The goal is to find genes that cause the disease and understand how it progresses in children who still have their own liver…

This study looks at how common tooth staining is in children who had very high bilirubin levels (jaundice) early in life. Researchers will check 120 children with certain liver conditions to see if their teeth are discolored and whether that affects their daily life. The goal is …

This study enrolls adults with known or suspected endocrine (hormone gland) disorders, such as diabetes or thyroid disease, to help researchers learn more about these conditions. Participants will undergo medical exams, blood and imaging tests, and possibly genetic testing. The m…

This registry will follow 510 adults undergoing therapeutic endoscopic ultrasound (EUS) for conditions like stomach or bile duct blockages, pancreatic fluid collections, or gallbladder inflammation. The goal is to see how well these procedures work over the long term and what fac…

This study looks at how a special high-MCT (medium-chain triglyceride) diet affects growth in infants with biliary atresia after Kasai surgery. Researchers will track weight and length in 300 babies under 3 months old. The goal is to gather information, not to test a new treatmen…

This study is testing a tool called B-COMPASS that uses a 22-question survey to predict whether people will follow their prescribed treatments. Researchers will enroll 3100 adults with cardiovascular, endocrine, immune, nerve, cancer, or rare diseases across Europe. The goal is t…

This study is using advanced whole-genome sequencing to find hidden genetic causes of cholestatic liver disease in adults whose condition remains unexplained after standard tests. Researchers will compare the DNA of 60 affected adults to a large group of healthy controls. The goa…

This study is looking at whether a substance called FGF19 in the blood, measured before surgery, can help predict how well children with biliary atresia will do after their operation. Researchers will follow 200 children for one year after surgery, checking liver function and whe…

This study aims to understand why some people develop a rare, serious liver disease called primary sclerosing cholangitis (PSC). Researchers will create 3D cell models from patient samples to study how specific genetic changes affect bile duct cells. The goal is to find new ways …

This study looks at the gut bacteria of 3000 adults with chronic liver diseases like autoimmune hepatitis and fatty liver. Researchers want to find specific bacteria linked to each disease to better understand how the gut and liver interact. This is an observational study, not a …

This study is testing whether a camera can accurately measure heart rate, blood pressure, and oxygen levels by recording a patient's face during surgery. The goal is to replace some of the sticky sensors and cuffs that touch the skin, which can cause infections or injuries in fra…

This study looks at 3,000 people with primary biliary cholangitis (PBC) to see how their blood levels of alkaline phosphatase (ALP) after treatment relate to their risk of liver complications. The goal is to create a model that predicts who will do well and who might need stronge…

This early-phase study at Stanford University is testing whether the statin drug rosuvastatin changes bile acid levels and gut bacteria in people with primary sclerosing cholangitis (PSC), a liver disease with no cure. Researchers will enroll 15 adults with PSC and inflammatory b…

This study collects bile and bile duct cells from people with Primary Sclerosing Cholangitis (PSC) and healthy volunteers to grow mini-livers called organoids. The goal is to understand how PSC progresses and leads to liver cancer. No treatment is given; it is purely for research…

This study compares two advanced techniques used when doctors have trouble reaching the bile duct during a procedure called ERCP. About 188 adults with difficult bile duct access will be randomly assigned to either an endoscopic ultrasound-guided rendezvous technique or an early …

This study is creating a large collection of blood, urine, stool, bile, and bile duct cells from up to 9,150 people with cholestatic liver diseases like primary biliary cholangitis and primary sclerosing cholangitis, as well as from healthy volunteers. The samples and medical dat…

This study compares two imaging techniques—laparoscopic ultrasound and a special dye called indocyanine green—to help surgeons see important bile duct structures during difficult gallbladder removal surgery. About 62 adults with conditions like acute cholecystitis, prior abdomina…

This study follows 40 liver transplant patients who develop non-anastomotic biliary strictures—narrowing of the bile ducts not at the connection point. Doctors use an endoscope to place plastic stents and then track how well the strictures resolve. The goal is to gather real-worl…

This study tracks 1,000 patients undergoing major liver, pancreas, or bile duct surgery to see if the time it takes for their albumin levels to return to normal can predict complications and length of hospital stay. Albumin is a protein that drops after surgery due to inflammatio…

This study aims to identify specific blood markers that can distinguish hepatitis caused by immune checkpoint inhibitors from other types of autoimmune hepatitis. Researchers will collect blood samples and liver tissue from 60 adults receiving immunotherapy. The goal is to improv…

This study aims to uncover the genetic and developmental causes of biliary atresia, a rare condition that leads to liver failure in newborns and accounts for half of all childhood liver transplants worldwide. Researchers will analyze DNA from 1,100 children who have had or need a…