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

Conditions

• Pancreatic Carcinoma
• Pancreatic Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample and pancreas fluid collection
• Distal Pancreatectomy — PROCEDURE
  Undergo distal pancreatectomy
• Lanreotide — DRUG
  Given SC
• Questionnaire Administration — OTHER
  Ancillary studies
• Saline — OTHER
  Given SC

Study Details

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.

Key Dates

Start date

May 9, 2025

Status verified

Dec 2025

Primary completion

Nov 1, 2027

Completion

Nov 1, 2027

Study Design

Enrollment

274 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Arm I (lanreotide, distal pancreatectomy)
  Patients receive lanreotide SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and on post-operative days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.
• Placebo Comparator: Arm II (saline placebo, distal pancreatectomy)
  Patients receive saline placebo SC over 20 seconds and within 36 hours of planned distal pancreatectomy. Patients also undergo blood sample collection immediately prior to surgery and post-operatively on days 1 and 3. Additionally, patients may undergo collection of pancreas fluid on post-operative days 1 and 3.

Primary Outcome Measure

Incidence of postoperative pancreatic fistula (POPF) [ Time Frame: Up to 60 days after distal pancreatectomy ]

Central Contacts

• Andrea Garcia
  210-614-8808
  [email protected]
• Dana Sparks
  210-614-8808
  [email protected]

Locations (118)

Find similar trials in Birmingham, AL

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