View clinical trials related to Malignant Biliary Obstruction.
Filter by:Cancers of the liver, pancreas and gall bladder can partially or fully block the bile duct leading to jaundice. Where these tumours are inoperable, maintaining adequate bile duct drainage is an important factor in survival, both as jaundice itself can ultimately be fatal and because and because it can prevent the administration of chemotherapy. The current standard care is the placement of a stent and possible manual 'trawling' in an attempt to clear the blockage. But these stents often become blocked by tumour ingrowth requiring reintervention. However it may not be safe to do so at this point. Intraductal radiofrequency ablation (IDRFA) uses heat energy both to 'necrose' the tumour tissue in attempt to slow ingrowth in the channels before inserting stents and to clear blocked stents. There is some evidence that this increases the length of time for the stents to become blocked or with secondary benefits to quality of life and survival however long term data from within the NHS setting is lacking. A full trial is not currently feasible therefore a pilot study is to be conducted to help inform the design of a full trial. This study will randomise patients attending with malignant biliary obstruction in a 1:1 ratio to receive either intraductal radiofrequency a. Participants will be recruited through the standard clinical pathway (i.e it will be offered to all potentially eligible patients) over a period of 12 months. Participants will be monitored for a period of up to 12 months for survival, stent blockage, symptoms, resource use, quality of life and adverse reactions. The study will be conducted between Royal Bournemouth Hospital and The Christie, both cancer care centres experienced in the management of these conditions, stent placement and radiofrequency ablation.
Malignant biliary obstruction commonly caused by pancreatic adenocarcinoma, cholangiocarcinoma and other etiologies like gallbladder carcinoma, hepatocellular carcinoma, lymphoma, and metastasis to regional solid organs and lymph nodes. Pancreatobiliary cancers generally present with jaundice, weight loss, and anorexia with significant impact on quality of life, morbidity, and mortality. The primary goal of diagnosis and management is curative resection but it's difficult due to local invasion and distant metastases at the time of clinical presentation. Biliary decompression helps to reduce symptoms and improve quality of life in patients with malignant biliary obstruction. Endoscopically placed stents have become the standard of care for non-surgical biliary drainage due to their minimal invasiveness compared to percutaneous drainage. The standard treatment of obstructive jaundice has been ERCP with biliary stent placement with high success rate in expert hands and low frequency of adverse events. Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been increasingly used in patients who underwent failed ERCP. EUS-BD can be performed in several ways, choledochoduodenostomy (CDS), hepaticogastrostomy (HGS), antegrade (AG) procedure, and rendezvous (RV) technique.
Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the event of malignant biliary stenosis, and a biliary calibration in the event of benign stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017, larger stents have been marketed in France and are approved for the biliary drainage of benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of our study was to compare whether the permeability of 12-mm diameter stent was better than a conventional 10-mm, covered or uncovered prosthesis depending on the indication.
Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and ERCP assisted trans-papillary drainage for malignant biliary obstruction. Subjects of the study: Patients who have malignant biliary obstruction. Methods of the study: - Prospective randomized controlled study - Patients were randomly divided into two groups, EUS-BD group or ERCP group - Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary drainage)for decompression of malignant biliary obstruction - After the procedure, regular follow up, blood test, and imaging test will be done to check sufficient biliary decompression, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events rate. Statistical methods: SPSS 23.0 statistical software was used. The measurement data was expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for count data.
The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.
The aim of this animal study is determining the technical feasibility of the novel flower-type covered self-expandable metal stent (F-CSEMS) and investigating whether the novel flower-type covered self-expandable metal stent (F-CSEMS) could prevent cholecystitis and pancreatitis, comparing with conventional covered self-expandable metal stent (C-CSEMS).
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. However, how primary ECDS compares with ERCP with covered self-expanding metallic stents (CSEMS) in unresectable malignant distal CBD strictures is uncertain. The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures. We hypothesis that ECDS is associated with a higher 1-year stent patency rate.
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.
Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction
Patients with obstructive jaundice due to locally advanced/metastatic malignancy with dilated intrahepatic bile ducts will be recruited from the department of Gastroenterology and Hepatology at the University Hospital of Leuven. This population will have failed ERCP or will be considered when ERCP is not possible due to altered surgical anatomy. Patients will be randomized to either PTC or EUS guided biliary drainage