Clinical trials: Biliary Obstruction
Pancreatic Fluid Collections, Biliary Obstruction
EUS Procedures Using RIVOS™ EUS Access Device
This is a prospective study of patients undergoing EUS procedures using the RIVOS™ EUS access device.
- Conditions
- Pancreatic Fluid Collections, Biliary Obstruction, Pancreatic Duct Obstruction, Chronic Pancreatitis
- Trial name
- NCT07696572
- Testing
- EUS-guided intervention using the RIVOS™ EUS access device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Orlando Health, Inc.
Malignant Biliary Obstruction
A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage
The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure.
- Trial name
- NCT03672019
- Testing
- FACT-Hep
- Where
- 5 sites in United States
- Volunteers
- 118 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Cholangiocarcinoma, Bile Duct Neoplasms
Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)
Malignant hilar biliary obstruction is a condition in which the bile ducts near the liver become blocked due to cancer. This blockage can lead to jaundice (yellowing of the skin and eyes), itching, infection, and impaired liver…
- Conditions
- Cholangiocarcinoma, Bile Duct Neoplasms, Malignant Biliary Obstruction
- Trial name
- SMART-B (NCT07558304)
- Testing
- Percutaneous transpapillary internal-external biliary drainage, Percutaneous suprapapillary biliary drainage with self-expanding metal stent
- Where
- 2 sites in Brazil
- Volunteers
- 84 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Malignant Biliary Obstruction, Malignant Biliary Stricture
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
The purpose of this study is to compare the efficacy and safety between EUS-HGAS and EUS-HGS. We hypothesized that EUS-HGAS provides lower recurrent biliary obstruction (RBO) rate but with a comparable safety profile to EUS-HGS.
- Trial name
- EASE-MBO (NCT07832045)
- Testing
- HGAS, HGS
- Where
- Taiwan
- Volunteers
- 88 people
- Sponsor
- National Taiwan University Hospital
Biliary Tract Neoplasms, Biliary Drainage
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile.
- Conditions
- Biliary Tract Neoplasms, Biliary Drainage, Malignant Biliary Obstruction, Obstructive Jaundice
- Trial name
- NCT07811791
- Testing
- Suprapapillary plastic stent placement, Transpapillary plastic stent placement
- Where
- 8 sites in Taiwan
- Volunteers
- 70 people
- Sponsor
- National Taiwan University Hospital
Malignant Distal Biliary Obstruction, Malignant Biliary Obstruction
12-mm Partial Covered Versus Bare Self-Expandable Metallic Stents for Malignant Distal Biliary Obstruction
Metallic stents are commonly used for biliary drainage in patients with unresectable malignant distal biliary obstruction. However, it is unclear whether a 12-mm partially covered self-expandable metallic stent or a 12-mm bare…
- Conditions
- Malignant Distal Biliary Obstruction, Malignant Biliary Obstruction, Biliary Obstruction
- Trial name
- PCSEMS-12 (NCT07559968)
- Testing
- 12-mm partially covered self-expandable metallic stent, 12-mm bare self-expandable metallic stent
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Chung-Ang University Hospital
Biliary Obstruction, Bile Duct Stricture
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY…
- Conditions
- Biliary Obstruction, Bile Duct Stricture, Bile Duct Diseases
- Trial name
- NCT04929821
- Testing
- Biliary Duct Stenting
- Where
- 6 sites in Hong Kong, India and 1 more
- Volunteers
- 100 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Fragility, Biliary Obstruction
Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery
This prospective, randomized, single-center study aims to evaluate and compare two different sedation and analgesia regimens used during percutaneous transhepatic biliary drainage (PTBD) procedures.
- Conditions
- Fragility, Biliary Obstruction, Cholangitis, Malignancy
- Trial name
- NCT07640243
- Testing
- Remifentanil, Ketamine
- Where
- Turkey (Türkiye)
- Volunteers
- 98 people
- Sponsor
- Ankara City Hospital Bilkent
Pancreatic Cancer, Malignant Biliary Obstruction
Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction
This study is a multicenter, randomized clinical trial designed to compare the effectiveness and safety of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) with a conventional plastic stent for preoperative…
- Trial name
- BRIDGE-8 (NCT07606430)
- Testing
- Modified 8-mm Fully Covered Self-Expandable Metal Stent, Plastic stent
- Volunteers
- 116 people
- Sponsor
- Soonchunhyang University Hospital
Biliary Obstruction
Quality of Life Assessment Between Internal Endoscopic Versus Percutaneous Drainage in Biliary Obstruction
The aim of this study is to compare the quality of life in subjects with benign and malignant biliary obstruction who have or will undergo endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous trans-hepatic…
- Trial name
- NCT04857424
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Mayo Clinic
Malignant Biliary Obstruction, Biliary Tract Neoplasms
EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for…
- Conditions
- Malignant Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Cancer Non-resectable
- Trial name
- CARPEGIEM (NCT06375967)
- Testing
- Endoscopic biliary drainage, Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- Where
- 10 sites in Spain
- Volunteers
- 128 people
- Sponsor
- Hospital Universitari de Bellvitge
Malignant Biliary Obstruction, Pancreatic Cancer
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)
The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction.
- Conditions
- Malignant Biliary Obstruction, Pancreatic Cancer, Biliary Tract Neoplasms
- Trial name
- NCT06653192
- Testing
- Endoscopic biliary drainage, Self-expandable metallic stent (SEMS), Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- Where
- 10 sites in Spain
- Volunteers
- 120 people
- Sponsor
- Hospital Universitari de Bellvitge
Gastric Outlet Obstruction, Biliary Obstruction
Prospective Registry Of Therapeutic EndoscopiC ulTrasound
This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of…
- Conditions
- Gastric Outlet Obstruction, Biliary Obstruction, Acute Pancreatic Fluid Collection, Acute Pancreatitis With Infected Necrosis
- Trial name
- PROTECT (NCT04813055)
- Testing
- Therapeutic EUS, Percutaneous Procedures, Surgical Interventions
- Where
- Italy
- Volunteers
- 510 people
- Sponsor
- Paolo Giorgio Arcidiacono, MD
Pregnancy Complications, Acute Appendicitis
Fetal Outcomes Among Pregnant Emergency General Surgery Patients
Approximately 1 in 500 pregnant women require non-obstetric surgery. Surgical care for the pregnant woman raises concern for complications adversely affecting pregnancy outcomes.
- Conditions
- Pregnancy Complications, Acute Appendicitis, Acute Cholecystitis, Biliary Pancreatitis
- Trial name
- NCT05085353
- Testing
- non-obstetric acute general surgical disease
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Methodist Health System
Malignant Biliary Obstruction
EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent
EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1.
- Trial name
- NCT05169398
- Testing
- EUS-guided hepaticogastrostomy
- Where
- Hong Kong
- Volunteers
- 20 people
- Sponsor
- Chinese University of Hong Kong
Endoscopic Retrograde Cholangiopancreatography (ERCP), Choledocholithiasis
Role of Prophylactic Aggressive Hydration to Prevent Post-ERCP Pancreatitis
Endoscopic Retrograde Cholangiopancreatography, also called ERCP, is a procedure used to diagnose and treat disorders of the bile ducts and pancreas.
- Conditions
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Choledocholithiasis, Bile Duct Disorder, Biliary Obstruction
- Trial name
- NCT07417020
- Testing
- Aggressive intravenous hydration with lactated Ringer's solution, Standard intravenous hydration with lactated Ringer's solution
- Where
- Pakistan
- Volunteers
- 126 people
- Sponsor
- Lahore General Hospital
Acute Cholangitis, Biliary Tract Infection
Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis
Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis…
- Conditions
- Acute Cholangitis, Biliary Tract Infection, Biliary Obstruction, Choledocholithiasis
- Trial name
- NCT07407491
- Testing
- Gentamicin - single dose, Distilled water
- Where
- Malaysia
- Volunteers
- 172 people
- Sponsor
- National University of Malaysia
Biliary Obstruction
Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage (MED-BD)
The purpose of this study is to investigate the likelihood of post-dilation bleeding using mechanical or electrocautery dilation. We hypothesized that the risk of bleeding is lower in the mechanical group.
- Trial name
- MED-BD (NCT06620328)
- Testing
- endoscopic ultrasonography-guided biliary drainage
- Where
- Taiwan
- Volunteers
- 64 people
- Sponsor
- National Taiwan University Hospital
Choledocholithiasis, Papillary Stenosis
Endoscopic Antegrade Sphincterotomy (ASD) Versus Standard Sphincterotomy
This study compares endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko (Antegrade Sphincterotomy Dovbenko, ASD) with conventional pull-type endoscopic sphincterotomy (EST) in patients undergoing…
- Conditions
- Choledocholithiasis, Papillary Stenosis, Biliary Obstruction, Gallstone Disease
- Trial name
- ASD (NCT04406961)
- Testing
- Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko., The antegrade sphincterotome developed by Dr. Dovbenko., Endoscopic sphincterotomy.
- Where
- Ukraine
- Volunteers
- 1,521 people
- Sponsor
- Military Medical Clinical Center of the Southern Region, Ukraine
Malignant Biliary Obstruction
RIVOS Feasibility (MBO)
The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for…
- Trial name
- NCT06666699
- Testing
- EUS access device
- Where
- 3 sites in Belgium, France and 1 more
- Sponsor
- Boston Scientific Corporation