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Grant: Project Grant

Research Institute of the McGill University Health Centre

$328,950.00

Endoscopic ultrasound-guided biliary drainage (EUS-BD) of first intent with a lumen apposing metal stent vs. endoscopic retrograde cholangiopancreatography (ERCP) in the management of patients with malignant distal biliary obstruction: a multi-centre randomized controlled trial (ELEMENT trial)

EF 2020-21

Résumé
Pancreatic cancer is one of the leading causes of cancer related deaths in Canada. It has the propensity to invade or compress the bile duct, which is the conduit that allows bile to flow from the liver to the small intestines. Bile duct obstruction leads to symptoms of jaundice (yellowing of the skin), itching of the skin, malnutrition (bile is necessary for fat digestion/absorption), bile duct infection, and liver dysfunction. Without adequate bile flow patients cannot start chemotherapy treatments, which requires adequate liver function. The standard treatment for bile duct obstruction is through an endoscopic procedure called ERCP where a camera is advanced through the patient's mouth to the natural opening of the bile duct. A metal stent (metal tube) can then be inserted to re-establish bile flow. Although effective this procedure is associated with up to 30% need for re-intervention due to stent blockage from tumor growing through the stent. Stent blockage is associated with risk of bile duct infection, re-hospitalization, re-intervention, interruption in chemotherapy treatment, decreased in quality of life, and cost to our health care system. A new modality using endoscopic ultrasound (another type of camera with ultrasound capability) and a novel metal stent allows the placement of the stent above the tumor creating a new tract between the bile duct and gastrointestinal lumen. This "bypass" stent is postulated to minimize the risk for stent obstruction from tumor ingrowth. The goal of our proposed study is to compare this new modality with ERCP. This is a randomized controlled trial (patients will receive one of the treatments at random similar to a "flip of a coin") involving 10 Canadian centres. We believe that the "bypass" stent is more effective with better stent patency leading to better oncological care for patients with pancreatic cancer. The results of our study could potential change our approach to cancer related bile duct obstruction.
Programme
Project Grant
Emplacement
Quebec, Canada
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
434673
Name
Chen Yen-I
Region
Québec
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Nutrition, Metabolism and Diabetes
Theme2
Clinical
Prcname2
Clinical Investigation - C: Digestive, Endocrine and Excretory Systems
Projecttitle
Endoscopic ultrasound-guided biliary drainage (EUS-BD) of first intent with a lumen apposing metal stent vs. endoscopic retrograde cholangiopancreatography (ERCP) in the management of patients with malignant distal biliary obstruction: a multi-centre randomized controlled trial (ELEMENT trial)
Programtype2
Operating Grants
Orgnameinp2
Research Institute of the McGill University Health Centre
Cihramount2
$328,950
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Bile Duct Drainage; Gastroenterology; Pancreatic Cancer; Pancreatic Surgery; Randomized Controlled Trial; Stents; Therapeutic Endoscopic Ultrasound; Therapeutic Gastrointestinal Endoscopy
Abstract
Pancreatic cancer is one of the leading causes of cancer related deaths in Canada. It has the propensity to invade or compress the bile duct, which is the conduit that allows bile to flow from the liver to the small intestines. Bile duct obstruction leads to symptoms of jaundice (yellowing of the skin), itching of the skin, malnutrition (bile is necessary for fat digestion/absorption), bile duct infection, and liver dysfunction. Without adequate bile flow patients cannot start chemotherapy treatments, which requires adequate liver function. The standard treatment for bile duct obstruction is through an endoscopic procedure called ERCP where a camera is advanced through the patient's mouth to the natural opening of the bile duct. A metal stent (metal tube) can then be inserted to re-establish bile flow. Although effective this procedure is associated with up to 30% need for re-intervention due to stent blockage from tumor growing through the stent. Stent blockage is associated with risk of bile duct infection, re-hospitalization, re-intervention, interruption in chemotherapy treatment, decreased in quality of life, and cost to our health care system. A new modality using endoscopic ultrasound (another type of camera with ultrasound capability) and a novel metal stent allows the placement of the stent above the tumor creating a new tract between the bile duct and gastrointestinal lumen. This "bypass" stent is postulated to minimize the risk for stent obstruction from tumor ingrowth. The goal of our proposed study is to compare this new modality with ERCP. This is a randomized controlled trial (patients will receive one of the treatments at random similar to a "flip of a coin") involving 10 Canadian centres. We believe that the "bypass" stent is more effective with better stent patency leading to better oncological care for patients with pancreatic cancer. The results of our study could potential change our approach to cancer related bile duct obstruction.
Competitiondate
202010
Approvedterm2
2 yrs 8 mths
Pinamesdelim
Chen, Yen-I; Barkun, Alan N
Approvedterm
2 ans 8 mois
Cihrcontribution2
~ $328,950~ $0~