Clinical Trials Logo

Clinical Trial Summary

Stenting the malignant biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated the safety and technical feasibility of an irradiation biliary stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.


Clinical Trial Description

Malignant biliary obstruction is a common condition caused by various carcinomas.The clinical process is usually silent and insidious,only 10-20% patients can be surgically removed once obstructive jaundice occurred.The long-term survival rate after resection remain dismal.Relief of obstructive jaundice plays major role on prognosis in patients without surgical indications.For unresectable patients,stenting the biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice.Although a number of new techniques for treatment of malignant biliary obstruction have been developed,there have been no significant differences in survival or quality of life comparing surgery bypass versus plastic stent insertion,metal stent insertion versus plastic stents insertion,or covered stent versus uncovered stents insertion in such patients.Our previous unicentric clinical trial has demonstrated the safety and technical feasibility of a biliary intraluminal irradiation stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion in the overall survival and stent patency between two groups.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02001779
Study type Interventional
Source Zhongda Hospital
Contact
Status Completed
Phase N/A
Start date October 2013
Completion date September 2016

See also
  Status Clinical Trial Phase
Recruiting NCT04941924 - The ID- RFA Trial: A Trial of Intraductal Radio-frequency Ablation (ID-RFA) Plus Biliary Stenting Versus Biliary Stenting Alone for the Treatment of Malignant Biliary Obstruction. N/A
Active, not recruiting NCT03672019 - A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage
Recruiting NCT05220475 - A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent N/A
Not yet recruiting NCT06375928 - EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial) N/A
Not yet recruiting NCT06375954 - EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial) N/A
Recruiting NCT05786326 - Multihole Fully Covered Metallic Stents in the Management of Malignant Biliary Obstruction N/A
Not yet recruiting NCT06375967 - EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) N/A
Completed NCT01869894 - A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction N/A
Not yet recruiting NCT05804201 - EUS-guided Hepatico-gastrostomy With Hot Giobor N/A
Recruiting NCT01686425 - Percutaneous Transhepatic Cholangiography Versus Endoscopic Ultrasound Guided Biliary Drainage N/A
Recruiting NCT03215108 - Comparison Between Novel Flower-type Covered Stent and Conventional Covered Stent N/A
Recruiting NCT04898777 - EUS-Guided Choledochoduodenostomy Versus ERCP for Primary Biliary Decompression in Distal Malignant Biliary Obstruction N/A
Recruiting NCT05169398 - EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent N/A
Enrolling by invitation NCT05233293 - Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma N/A
Completed NCT03812250 - EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction N/A
Completed NCT03000855 - EUS - Guided Choledocho-duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Common Bile Duct Strictures Phase 2/Phase 3
Recruiting NCT01073514 - Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction N/A
Recruiting NCT05142839 - Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction. N/A
Recruiting NCT05729867 - Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable HCC N/A
Completed NCT04405752 - Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study