Clinical trials: Malignant Distal Biliary Obstruction
Endoscopic Retrograde Cholangiopancreatography, Biliary Drainage
EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction (AXIOS-CPRE)
The main objective is to compare the EUS-BD with the insertion of a LAMS vs. traditional ERCP to restore biliary patency. Although ERCP has been the primary treatment for many years, it is associated with a significant risk of…
- Conditions
- Endoscopic Retrograde Cholangiopancreatography, Biliary Drainage, Echography Ultrasound
- Trial name
- AXIOS-CPRE (NCT05122858)
- Testing
- EUS guided biliary drainage, ERCP
- Where
- France
- Volunteers
- 15 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Malignant Biliary Obstruction, Pancreatic Cancer
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction.
- Conditions
- Malignant Biliary Obstruction, Pancreatic Cancer, Biliary Tract Neoplasms
- Trial name
- NCT06375954
- Testing
- Endoscopic biliary drainage, Self-expandable metallic stent (SEMS), Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- Where
- Spain
- Volunteers
- 96 people
- Sponsor
- Hospital Universitari de Bellvitge
Periampullary Cancer, Complications of Surgical Procedures or Medical Care
Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage
This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary…
- Conditions
- Periampullary Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent
- Trial name
- NCT01789502
- Testing
- Fully covered metal stents, Plastic stents
- Where
- 3 sites in South Korea
- Volunteers
- 86 people
- Sponsor
- Inje University
Biliary Obstruction
EUS Biliary Drainage vs. ERCP
Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction.
- Trial name
- NCT03870386
- Testing
- EUS-BD with LAMS, ERCP
- Where
- 11 sites in Canada, France
- Volunteers
- 144 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Bile Duct Obstruction
A Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Background and rationale Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered.
- Trial name
- NCT03628001
- Testing
- ERCP
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Istituto Clinico Humanitas
Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas
Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction
A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.
- Conditions
- Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas, Cancer of the Bile Duct, Biliary Stricture
- Trial name
- NCT03821025
- Testing
- Biliary stent
- Where
- South Africa
- Volunteers
- 150 people
- Sponsor
- University of Cape Town
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
Malignant Biliary Obstruction
EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures
EUS - guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal CBD strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails.
- Trial name
- DRAMBO (NCT03000855)
- Testing
- EUS-guided choledocho-duodenostomy, Endoscopic retrograde cholangiopancreatography with covered metallic stent
- Where
- 6 sites in Australia, Belgium and 3 more
- Volunteers
- 77 people
- Sponsor
- Chinese University of Hong Kong
Malignant Biliary Obstruction
PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial
Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction.
- Trial name
- PROMETHEUS (NCT06550973)
- Testing
- pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique
- Volunteers
- 220 people
- Sponsor
- Istituto Clinico Humanitas
Malignant Biliary Stricture
Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture
Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone of biliary drainage method in these…
- Trial name
- NCT03530527
- Testing
- ERCP with biliary stenting, EUS guided biliary drainage
- Where
- 2 sites in Thailand
- Volunteers
- 10 people
- Sponsor
- Prince of Songkla University
Jaundice
Biliary Drainage in Patients With Duodenal Metal Stent
This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.
- Trial name
- NCT02376907
- Testing
- Biliary drainage
- Where
- 25 sites in China, Hong Kong and 7 more
- Volunteers
- 200 people
- Sponsor
- Tokyo University
Biliary Condition
Difficult Biliary Cannulation in Patients With Distal Malignant Biliary Obstruction: an Underestimated Problem
Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic procedure for many bilio-pancreatic diseases, and requires the first crucial step of the successful deep cannulation of the common bile duct through…
- Trial name
- DBC 01 (NCT04709666)
- Testing
- Endsocopic Retrograde ColangioPancreatography (ERCP)
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- Istituto Clinico Humanitas
Biliary Tract Neoplasms, Jaundice, Obstructive
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents
Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard intervention for the relief of obstructive jaundice in patients with unresectable malignant biliary obstruction.
- Trial name
- NCT01315522
- Testing
- ComVi stent, Uncovered SEMS
- Where
- 3 sites in South Korea
- Volunteers
- 43 people
- Sponsor
- Seoul National University Hospital
Bile Duct Obstruction, Pancreatic Cancer
Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g.
- Conditions
- Bile Duct Obstruction, Pancreatic Cancer, Gallbladder Cancer, Bile Duct Cancer
- Trial name
- NCT00280709
- Testing
- "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
- Where
- Sweden
- Volunteers
- 400 people
- Sponsor
- University Hospital, Linkoeping
Pancreatic Cancer, Pancreatic Neoplasms
Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction
The purpose of this study is to compare the rates of adverse events between patients undergoing Endoscopic Ultrasound- guided biliary drainage and Endoscopic Retrograde Cholangiopancreatography for distal malignant biliary…
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Adenocarcinoma
- Trial name
- NCT03054987
- Testing
- EUS-BD, ERCP
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- AdventHealth
Distal Malignant Biliary Obstruction
Fesibility of EUS-guided Gallbladder Drainage With a New-type of Electrocautery LAMS in the Treatment of Malignant Distal Biliary Obstruction
Distal malignant biliary obstruction results from different types of tumors including pancreatic cancer, biliary tract cancer (BTC), gallbladder cancer, and metastasis, which can lead to obstructive jaundice.
- Trial name
- DC LAMS (NCT05271994)
- Testing
- endoscopic biliary drainage
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Istituto Clinico Humanitas Mater Domini
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
Biliary Obstruction, Pancreas Neoplasm
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to…
- Conditions
- Biliary Obstruction, Pancreas Neoplasm, Distal Cholangiocarcinoma
- Trial name
- SCORPION-II-p (NCT05595122)
- Testing
- EUS-CDS
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Distal Bile Duct Obstruction
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct…
- Trial name
- NCT01905384
- Testing
- Covered Self-expanding metal biliary stents (C-SEMS), Uncovered Self-expanding metal biliary stents (U-SEMS)
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University Medical Center
Biliary Obstruction
Feasibility of EUS-guided Biliary Drainage With LAMS for the Treatmentof Patients With Distal Malignant Biliary Obstruction
Distal malignant biliary obstruction results from different types of tumors including pancreatic cancer, biliary tract cancer (BTC), gallbladder cancer, and metastasis, which can lead to obstructive jaundice.
- Trial name
- SPAXUS (NCT04723199)
- Testing
- Electrocautetery LAMS
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Istituto Clinico Humanitas