Clinical trials: Disorders of Biliary Tract
Cholecystitis, Cholelithiasis
Fluorescent Cholangiography vs White Light for Bile Ducts Identification
The Study is designed to compare the effectiveness of Near Infrared Fluorescence Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying the main biliary and hepatic structures (Cystic Duct…
- Trial name
- NCT02702843
- Testing
- Laparoscopic cholecystectomy with Xenon light, Laparoscopic cholecystectomy (fluorescent cholangiography)
- Where
- 7 sites in United States, Argentina and 3 more
- Volunteers
- 677 people
- Sponsor
- The Cleveland Clinic
Biliary Tract Neoplasms, Pancreatic Neoplasms
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive…
- Conditions
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
- Trial name
- NCT00196105
- Testing
- 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, 10 mm Stainless Steel Wallstent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Cook Group Incorporated
Sphincter of Oddi Dysfunction
Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction
The Evaluating Predictors \& Interventions in Sphincter of Oddi Dysfunction(SOD) study (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as treatment for patients with pain after…
- Trial name
- EPISOD (NCT00688662)
- Testing
- ERCP with sphincterotomy, ERCP without sphincterotomy
- Where
- 7 sites in United States
- Volunteers
- 214 people
- Sponsor
- Medical University of South Carolina
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Tract Cancer
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy
This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and…
- Trial name
- NCT02579616
- Testing
- Lenvatinib
- Where
- 7 sites in Japan
- Volunteers
- 29 people
- Sponsor
- Eisai Co., Ltd.
Primary Biliary Cirrhosis
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT01865812
- Testing
- Obeticholic Acid
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Intercept Pharmaceuticals
Liver Cirrhosis, Biliary
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver…
- Trial name
- COBALT (NCT02308111)
- Testing
- Obeticholic Acid (OCA)
- Where
- 181 sites in United States, Argentina and 29 more
- Volunteers
- 334 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cholangitis
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT06488911
- Testing
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Where
- 51 sites in United States, Argentina and 19 more
- Volunteers
- 62 people
- Sponsor
- Intercept Pharmaceuticals
Cholestasis
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's…
- Trial name
- NCT01173159
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Solid Tumor, Gastric Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
Hilar Cholangiocarcinoma
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)
Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat.
- Trial name
- NCT02082522
- Testing
- Photodynamic therapy-Photofrin, Stenting procedure, Chemotherapy regimen
- Where
- 31 sites in United States, Canada and 3 more
- Volunteers
- 28 people
- Sponsor
- Concordia Laboratories Inc.
Adult Primary Cholangiocellular Carcinoma, Advanced Adult Primary Liver Cancer
Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers
This phase II trial is studying how well giving cediranib maleate together with combination chemotherapy works in treating patients with advanced biliary cancers.
- Conditions
- Adult Primary Cholangiocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder
- Trial name
- NCT01229111
- Testing
- cediranib maleate, oxaliplatin, leucovorin calcium
- Where
- 7 sites in United States
- Volunteers
- 14 people
- Sponsor
- National Cancer Institute (NCI)
Biliary Stones
Non-Complex Biliary Stones DSC vs ERC
To prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (DSC) utilizing the SpyGlass™ system with non-complex biliary stone clearance using standard endoscopic…
- Trial name
- NCT03421340
- Testing
- DSC, ERC
- Where
- 8 sites in United States, India and 2 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Primary Sclerosing Cholangitis
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.
- Trial name
- PSC (NCT01085760)
- Testing
- Vancomycin, Metronidazole
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Alagille Syndrome
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and…
- Trial name
- ITCH (NCT02057692)
- Testing
- LUM001
- Where
- 13 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Bile Duct Neoplasms, Colorectal Neoplasms
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma
Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy.
- Trial name
- NCT04276090
- Testing
- Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter., Hepatic artery infusion pump floxuridine and dexamethasone, Systemic chemotherapy for colorectal liver metastases
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Michael J Cavnar, MD
Biliary Tract Cancer
A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
This study is for patients with biliary tract cancer that has spread and who are not candidates for surgical resection. The purpose of this research is to determine if bevacizumab can be safely administered with Modified FOLFOX 6…
- Trial name
- NCT00881504
- Testing
- "Bevacizumab" in combination with "modified FOLFOX6".
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Georgetown University
Cholestasis, Jaundice, Obstructive
SMOFlipid to Lessen the Severity of Neonatal Cholestasis
Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function.
- Trial name
- NCT02721277
- Testing
- SMOFlipid
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- University of Florida
Depression, Fatigue
Programs To Support You During Chemotherapy
This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy.
- Conditions
- Depression, Fatigue, Stage IIA Colorectal Cancer, Stage IIB Colorectal Cancer
- Trial name
- PRO-YOU (NCT02489422)
- Testing
- Laboratory Biomarker Analysis, Questionnaire Administration, Daily Survey Administration
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- Wake Forest University Health Sciences
Primary Biliary Cirrhosis
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or…
- Trial name
- NCT02955602
- Testing
- MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 119 people
- Sponsor
- Gilead Sciences