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

What Was Tested

In this phase 3 trial, researchers set out to test Lanreotide.

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 had two arms (groups): Arm I (lanreotide, distal pancreatectomy) (experimental) and Arm II (saline placebo, distal pancreatectomy) (placebo comparator).

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.

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.

The registry classes the interventions as drug, other and procedure.

More on the Plan

To compare the incidence of postoperative pancreatic fistula (POPF) occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm.

To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo.

To compare time from surgery to initiation of adjuvant chemotherapy among participants with pancreatic ductal adenocarcinoma and planned adjuvant chemotherapy randomized to receive preoperative lanreotide versus placebo.

To bank blood, pancreas fluid, and tissue specimens for future correlative studies.

Who Took Part

Enrollment: 274 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization. Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization.

The full record lists 26 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Lanreotide and who got the comparison, which limits bias.

The Lanreotide group and the comparison group ran side by side rather than switching.

As a double-blind Lanreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2025-05-09 with completion listed for 2027-11-01.

It ran at 118 sites in United States (118).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of postoperative pancreatic fistula (POPF) (time frame: Up to 60 days after distal pancreatectomy).

It also tracked 3 secondary outcomes, for example Incidence of biochemical leak (BL), Number of post-operation hospital days and Change in overall quality of life (QOL).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 274 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lanreotide compound page, all human trials.