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Grant: Project Grant

Queen's University (Kingston, Ontario)

$742,052.00

A Randomized Phase III Multicentre Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

EF 2024-25

Résumé
Pancreatic surgery is complex and leads to death or major complication rates of up to 57%. The defining complication after pancreatic surgery is postoperative pancreatic fistula (POPF). POPF - also known as "pancreatic leak" - is the release of digestive fluid from the pancreas which can cause damage to surrounding tissue. This can lead to worsened patient-reported pain, fatigue, and gastrointestinal symptoms, as well as life-threatening conditions, including intra-abdominal abscess, uncontrolled bleeding, and death. Further, development of POPF delays and in some cases negates receipt of adjuvant chemotherapy, a critical component of the multidisciplinary management of pancreas cancer. Treating POPF may require invasive procedures, increasing length of hospital stay and a near doubling of postoperative healthcare costs. A type of drug called somatostatin analogues (SSAs) reduce pancreatic digestive fluid secretion and have therefore been theorized to reduce POPF. Pasireotide, an SSA, has been shown to significantly decrease more severe POPF or abscess formation, however, it has had limited uptake due to cost, inconvenient administration (twice daily injections), troublesome side effects (nausea and vomiting), and is not approved for this use by Health Canada. Lanreotide, another type of SSA, is a promising alternative as it is administered via one preoperative dose, has reduced side effects (nausea and vomiting), and is more widely available. This grant will support Canadian participation in a North American trial including adult patients undergoing a distal pancreatectomy for cancer-related indication who will receive either lanreotide or placebo before surgery and will be followed for 60 days after surgery to monitor for POPF, other complications, and quality of life.
Programme
Project Grant
Emplacement
Ontario, Canada
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
509483
Name
O'Callaghan Christopher J
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Cancer Research
Theme2
Clinical
Prcname2
Randomized Controlled Trials 3
Projecttitle
A Randomized Phase III Multicentre Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
Programtype2
Operating Grants
Orgnameinp2
Queen's University (Kingston, Ontario)
Cihramount2
$742,052
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Distal Pancreatectomy; Lanreotide; Pancreatic Cancer; Phase Iii; Postoperative Pancreatic Fistula (Popf); Quality Of Life; Rct; Somastatin Analogues (Ssas); Surgery
Abstract
Pancreatic surgery is complex and leads to death or major complication rates of up to 57%. The defining complication after pancreatic surgery is postoperative pancreatic fistula (POPF). POPF - also known as "pancreatic leak" - is the release of digestive fluid from the pancreas which can cause damage to surrounding tissue. This can lead to worsened patient-reported pain, fatigue, and gastrointestinal symptoms, as well as life-threatening conditions, including intra-abdominal abscess, uncontrolled bleeding, and death. Further, development of POPF delays and in some cases negates receipt of adjuvant chemotherapy, a critical component of the multidisciplinary management of pancreas cancer. Treating POPF may require invasive procedures, increasing length of hospital stay and a near doubling of postoperative healthcare costs. A type of drug called somatostatin analogues (SSAs) reduce pancreatic digestive fluid secretion and have therefore been theorized to reduce POPF. Pasireotide, an SSA, has been shown to significantly decrease more severe POPF or abscess formation, however, it has had limited uptake due to cost, inconvenient administration (twice daily injections), troublesome side effects (nausea and vomiting), and is not approved for this use by Health Canada. Lanreotide, another type of SSA, is a promising alternative as it is administered via one preoperative dose, has reduced side effects (nausea and vomiting), and is more widely available. This grant will support Canadian participation in a North American trial including adult patients undergoing a distal pancreatectomy for cancer-related indication who will receive either lanreotide or placebo before surgery and will be followed for 60 days after surgery to monitor for POPF, other complications, and quality of life.
Competitiondate
202409
Approvedterm2
4 yrs 0 mth
Pinamesdelim
O'Callaghan, Christopher J; Karanicolas, Paul J
Approvedterm
4 ans 0 mois
Cihrcontribution2
~ $742,052~ $0~