Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Klatskin Tumor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Bismuth

metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

biliary stent (self expandable metallic stent)

plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

apichat sangchan, MD

The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency (\~3-9 months).

Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.

Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial

Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.

Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.

survival times of the patients after the first stent insertion

cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature

Khon Kaen University

Assist. Prof.

SEMS

Plastic Stent

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Thailand

Region of Enrollment

Assist. Prof. Apichat Sangchan

All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)

Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)

Patients Survival Times

Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma

Cost Effective Ratio of Metallic and Plastic Stent

91 participants who had successful stent insertion were analyzed based on per protocol analysis.

Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Immunomodulating Agents

Durvalumab

Antineoplastic Agents, Immunological

Durvalumab 1500 mg every 4 weeks until the progression of disease, discontinuation due to toxicity or withdrawal of consent, for a maximum duration of 2 years.

Valérie GOUNANT

Michael DURUISSEAUX

Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC).

The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy.

The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients.

For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS \>3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.

Immunotherapy in Patient With Poor General Condition

A Phase II Single-arm Trial Evaluating Safety and Efficacy of Durvalumab in ECOG Performance Status 2-3, Treatment-naive, Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) and High PD-L1 Tumor Expression

The maximum grade will be summarized by frequency and proportion of total patients, by system organ class and NCI-CTC, Version 5.0 categories.

Percentage of patients with objective response or stable disease according to RECIST 1.1 in the intent to treat population

Percentage of patients with objective response according to RECIST 1.1 in the intent to treat population

Time between the date of durvalumab initiation and the first date of documented progression or death due to any cause, whichever occurs first.

Time between the date of durvalumab initiation and the date of death due to any cause, whichever occurs first.

Proportion of per-protocol patients whose PS during durvalumab treatment was improved from baseline

EORTC QLQ-C30 +LC13 (Qualify of Life Questionnaire C30 + Lung Cancer 13) questionnaire

EQ-5D (EuroQol 5 Dimensions) questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma	NCT00721175	Hilar Cholangio...	biliary stent (... PS	18 Years -	Khon Kaen University
Immunotherapy in Patient With Poor General Condition	NCT04108026	Non-small Cell ...	Durvalumab	18 Years - 75 Years	Intergroupe Francophone de Cancerologie Thoracique

Spots Global Cancer Trial Database for ps

Every month we try and update this database with for ps cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ps

Every month we try and update this database with for ps cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ps cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.