Lanreotide Before Surgery for Pancreatic Fistula Prevention
This study is testing if giving lanreotide before surgery can help prevent a complication called a pancreatic fistula (a leak of pancreatic fluid) in people having surgery for pancreatic cancer or other pancreatic growths that could become cancerous. Lanreotide is a drug similar to a natural body hormone that can affect how certain hormones are made and might slow tumor growth. You could be eligible if you have pancreatic cancer or a pancreatic lesion with malignant potential and are scheduled for a distal pancreatectomy (surgery to remove part of the pancreas). The main goal is to see if lanreotide reduces the number of people who get a pancreatic fistula within 60 days after surgery. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 274 participants. It compares lanreotide to a placebo (an inactive substance) given before surgery.
- What's involved
- You would receive lanreotide or saline (placebo) by injection under the skin. You would also undergo blood and pancreas fluid collection, and complete questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your condition will be monitored for up to 60 days after your surgery.
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NCT06807437
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Recruiting
PHASE3Ages 18+InterventionalPreventionSWOG Cancer Research NetworkGovernment-funded
~274 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Biospecimen CollectionDistal PancreatectomyLanreotideQuestionnaire AdministrationSaline
At a glance
Recruiting sites
18 of 118 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of postoperative pancreatic fistula (POPF)
Measured over Up to 60 days after distal pancreatectomy
Conditions
Where it's being run
118 sites across 29 statesMinnesota20
Michigan12
Wisconsin11
Pennsylvania7
Illinois6
Alabama5
California5
Florida5
Study leadership
- Jonathan G Sham · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
Participants must be ≥ 18 years old
Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization
Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR a measured OR calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft -Gault formula within 60 days prior to registration/randomization
Participants must complete a pre-registration screening to identify any of the medications below, allowing the study team and treating physician to develop a monitoring plan as needed. Participants taking medications with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place. These medications include:
Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be monitored, and medication dose adjustments made as needed
Cyclosporine: Dosage adjustments may be required to maintain therapeutic levels
Bromocriptine: Dose adjustments may be considered to account for absorption changes
Heart medications (e.g., beta blockers): Heart rate will be monitored, and medication doses adjusted if necessary
CYP3A4-metabolized medications: Dose adjustments may be considered to avoid increased exposure
In the opinion of the treating surgeon, based on preoperative data, the participant must not require a modified Appleby-type procedure (distal pancreatectomy with celiac axis resection) or multivisceral resection (e.g., stomach, colon, etc.) at the time of distal pancreatectomy
NOTE: planned removal of the gallbladder or spleen at the time of distal pancreatectomy is not considered multivisceral resection and is permissible
In the opinion of the treating surgeon, based on preoperative data, the participant must not require a tumor enucleation
Participants must not have moderate to severe hepatic impairment as defined by liver enzyme elevation more than 5 times the institutional upper limit of normal (either aspartate aminotransferase \[AST\] \> 190 U/L or alanine aminotransferase \[ALT\] \> 320 U/L) within 60 days prior to registration/randomization. Transient elevation at the time of screening that resolves prior to study enrollment is acceptable
Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped)
Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during the whole period of the study and for three months after the study drug administration, with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
Participants must be offered the opportunity to participate in specimen banking
Participants who can complete EORTC QLQ-C30, EORTC QLQ-PAN26, and EQ-5D-5L forms in English or Spanish, must be offered the opportunity to participate in the quality-of-life study
NOTE: As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
What this trial measures
- Incidence of postoperative pancreatic fistula (POPF)Up to 60 days after distal pancreatectomy
POPF will be assessed using the 2016 International Study Group for Pancreas Surgery (ISGPS). Incidence rates of POPF in each treatment arm will be described, and treatment arm differences assessed via logistic regression model with adjustment for stratification factor.