Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network

About this trial

This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.

Eligibility criteria

Qualifiers

Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential

Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date

Participants must not have a known history of a prior diagnosis of malabsorption syndrome

Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Distal Pancreatectomy
  • Lanreotide
  • Questionnaire Administration
  • Saline

Treatment groups

274 Participants
are divided into 2 treatment groups

Sponsors and collaborators

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator