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Taking people in United StatesPhase 3

Lanreotide before surgery to prevent a pancreas leak in pancreatic disease

Tests lanreotide before surgery to prevent leaks in adults with pancreatic tumors.

Key facts

Who runs it
SWOG Cancer Research Network
Where
Aitkin, Albuquerque, Allentown, Ann Arbor, Ashland, Atlanta, Battle Creek, Baxter, Bethlehem, Birmingham, Brainerd, Burlington, Chadds Ford, Charlotte, Chicago, Cincinnati, Columbus, Concord, Crosslake, Daphne, Deer River, Detroit Lakes, Duarte, Duluth, Easton, Elkton, Ely, Fairhope, Fargo, Farmington, Fosston, Geneva, Gilbert, Grand Rapids, Hayward, Hibbing, Indianapolis, International Falls, Jamestown, Johns Creek, Knoxville, La Jolla, Lexington, Livingston, Loma Linda, Los Angeles, Marshfield, Memphis, Mobile, Moose Lake, Mukwonago, Muskegon, New Brunswick, New Orleans, Newark, Niles, Norton Shores, Oak Brook, Oconomowoc, Omaha, Orland Park, Park Rapids, Pequot Lakes, Pine River, Quakertown, Reed City, Reno, Richmond, Roanoke, Rochester, Ruskin, Saint Joseph, Sainte Genevieve, San Diego, Sandstone, Saraland, Seattle, Sioux Falls, Spooner, St Louis, Staples, Stroudsburg, Sullivan, Sunset Hills, Superior, Syracuse, Tampa, Virginia, Warrenville, Waukesha, Wesley Chapel, West Chester, Wilkes-Barre, Wilmington, Winchester, and Wyoming, United StatesSee the 118 sites
Trial code
Registry title
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Status
Recruiting
Phase
Phase 3
People taking part
274 people, planned
Started
9 May 2025
Expected to end
1 Apr 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Biospecimen Collection
  • Distal Pancreatectomy
  • Lanreotide
  • Questionnaire Administration
  • Saline
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pancreatic cancer or a pancreatic lesion that could become cancer, who have a planned distal pancreatectomy. It tests lanreotide before surgery to prevent a pancreatic fistula.

Age
18 years or older
Sex
All sexes can join
Disease stage
Pancreatic cancer or a pancreatic lesion that could become cancer, confirmed by tissue tests or imaging. A planned (elective) distal pancreatectomy within 60 days after registration.
Earlier treatment
No somatostatin analogue within 180 days before joining. No radiation therapy for the pancreas cancer. No peptide receptor radionuclide therapy (PRRT).

Main reasons for not taking part

  • Known history of malabsorption syndrome
  • Surgery needing a modified Appleby-type procedure, multivisceral resection or tumor enucleation
  • Moderate to severe liver problems (AST above 190 U/L or ALT above 320 U/L)
  • Pregnant or nursing
  • Kidney function too low (creatinine clearance below 50 mL/min)

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Where in United States

  • Riverwood Healthcare CenterAitkin, United StatesContact: Andrea GarciaNo longer taking part
  • University of New Mexico Cancer CenterAlbuquerque, United StatesContact: Andrea GarciaNo longer taking part
  • Saint Luke's Cancer Center - AllentownAllentown, United StatesContact: Darius C. Desai (principal investigator)Taking people
  • University of Michigan Rogel Cancer CenterAnn Arbor, United StatesContact: Andrea GarciaNo longer taking part
  • Duluth Clinic AshlandAshland, United StatesContact: Andrea GarciaNo longer taking part
  • Northwest Wisconsin Cancer CenterAshland, United StatesContact: Andrea GarciaNo longer taking part
  • Emory Saint Joseph's HospitalAtlanta, United StatesContact: Andrea GarciaNo longer taking part
  • Emory University Hospital MidtownAtlanta, United StatesContact: Andrea GarciaNo longer taking part
  • Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesContact: Andrea GarciaNo longer taking part
  • Grady Health SystemAtlanta, United StatesContact: Andrea GarciaNo longer taking part
  • Bronson Battle CreekBattle Creek, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Baxter ClinicBaxter, United StatesContact: Andrea GarciaNo longer taking part
  • Saint Luke's University Hospital-Bethlehem CampusBethlehem, United StatesContact: Darius C. Desai (principal investigator)Taking people
  • University of Alabama at Birmingham Cancer CenterBirmingham, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health Saint Joseph's Medical CenterBrainerd, United StatesContact: Andrea GarciaNo longer taking part
  • University of Vermont and State Agricultural CollegeBurlington, United StatesContact: Andrea GarciaNo longer taking part
  • University of Vermont Medical CenterBurlington, United StatesContact: Andrea GarciaNo longer taking part
  • Christiana Care Health System-Concord Health CenterChadds Ford, United StatesContact: Andrea GarciaNo longer taking part
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesContact: Andrea GarciaNo longer taking part
  • Northwestern UniversityChicago, United StatesContact: Akhil Chawla (principal investigator)Taking people
  • University of IllinoisChicago, United StatesContact: Aslam Ejaz (principal investigator)Taking people
  • University of Cincinnati Cancer Center-UC Medical CenterCincinnati, United StatesContact: Andrea GarciaNo longer taking part
  • Ohio State University Comprehensive Cancer CenterColumbus, United StatesContact: Andrea GarciaNo longer taking part
  • Atrium Health Cabarrus/LCI-ConcordConcord, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Saint Joseph's Crosslake ClinicCrosslake, United StatesContact: Andrea GarciaNo longer taking part
  • Gulf Health Hospitals Inc/Infirmary Cancer Care - MalbisDaphne, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Deer River ClinicDeer River, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health Saint Mary's - Detroit Lakes ClinicDetroit Lakes, United StatesContact: Andrea GarciaNo longer taking part
  • City of Hope Comprehensive Cancer CenterDuarte, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health Cancer CenterDuluth, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health Saint Mary's Medical CenterDuluth, United StatesContact: Andrea GarciaNo longer taking part
  • Miller-Dwan HospitalDuluth, United StatesContact: Andrea GarciaNo longer taking part
  • Saint Luke's Hospital-Anderson CampusEaston, United StatesContact: Darius C. Desai (principal investigator)Taking people
  • Christiana Care - Union HospitalElkton, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Ely ClinicEly, United StatesContact: Andrea GarciaNo longer taking part
  • Thomas HospitalFairhope, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health Cancer Center-South University ClinicFargo, United StatesContact: Andrea GarciaNo longer taking part
  • Sanford Broadway Medical CenterFargo, United StatesContact: Andrea GarciaNo longer taking part
  • Sanford Roger Maris Cancer CenterFargo, United StatesContact: Andrea GarciaNo longer taking part
  • Parkland Health Center - FarmingtonFarmington, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Essentia Health - FosstonFosston, United StatesContact: Andrea GarciaNo longer taking part
  • Northwestern Medicine Cancer Center DelnorGeneva, United StatesContact: Andrea GarciaNo longer taking part
  • Banner MD Anderson Cancer CenterGilbert, United StatesContact: Andrea GarciaNo longer taking part
  • Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United StatesContact: Andrea GarciaNo longer taking part
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesContact: Andrea GarciaNo longer taking part
  • Trinity Health Grand Rapids HospitalGrand Rapids, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health-Hayward ClinicHayward, United StatesContact: Andrea GarciaNo longer taking part
  • Tamarack Health Hayward Medical CenterHayward, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health Hibbing ClinicHibbing, United StatesContact: Andrea GarciaNo longer taking part
  • Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - International Falls ClinicInternational Falls, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Jamestown ClinicJamestown, United StatesContact: Andrea GarciaNo longer taking part
  • Emory Johns Creek HospitalJohns Creek, United StatesContact: Andrea GarciaNo longer taking part
  • University of Tennessee - KnoxvilleKnoxville, United StatesContact: Andrea GarciaNo longer taking part
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesContact: Andrew M. Lowy (principal investigator)Taking people
  • University of Kentucky/Markey Cancer CenterLexington, United StatesContact: Michael J. Cavnar (principal investigator)Taking people
  • Saint Barnabas Medical CenterLivingston, United StatesContact: Andrea GarciaNo longer taking part
  • Veterans Affairs Loma Linda Healthcare SystemLoma Linda, United StatesContact: Andrea GarciaNo longer taking part
  • USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesContact: Andrea GarciaNo longer taking part
  • Marshfield Medical Center-MarshfieldMarshfield, United StatesContact: Jessica A. Wernberg (principal investigator)Taking people
  • Baptist Memorial Hospital and Cancer Center-MemphisMemphis, United StatesContact: Andrea GarciaNo longer taking part
  • Mobile Infirmary Medical CenterMobile, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Moose Lake ClinicMoose Lake, United StatesContact: Andrea GarciaNo longer taking part
  • ProHealth D N Greenwald CenterMukwonago, United StatesContact: Andrea GarciaNo longer taking part
  • Trinity Health Muskegon HospitalMuskegon, United StatesContact: Andrea GarciaNo longer taking part
  • Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesContact: Andrea GarciaNo longer taking part
  • University Medical Center New OrleansNew Orleans, United StatesContact: Andrea GarciaNo longer taking part
  • Christiana Care Health System-Christiana HospitalNewark, United StatesContact: Andrea GarciaNo longer taking part
  • Helen F Graham Cancer CenterNewark, United StatesContact: Andrea GarciaNo longer taking part
  • Medical Oncology Hematology Consultants PANewark, United StatesContact: Andrea GarciaNo longer taking part
  • Corewell Health Lakeland Hospitals - Niles HospitalNiles, United StatesContact: Andrea GarciaNo longer taking part
  • Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, United StatesContact: Andrea GarciaNo longer taking part
  • Northwestern Medicine Oak BrookOak Brook, United StatesContact: Andrea GarciaNo longer taking part
  • ProHealth Oconomowoc Memorial HospitalOconomowoc, United StatesContact: Andrea GarciaNo longer taking part
  • University of Nebraska Medical CenterOmaha, United StatesContact: Andrea GarciaNo longer taking part
  • Northwestern Medicine Orland ParkOrland Park, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Park RapidsPark Rapids, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Saint Joseph's Pequot Lakes ClinicPequot Lakes, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health - Saint Joseph's Pine River ClinicPine River, United StatesContact: Andrea GarciaNo longer taking part
  • Saint Luke's Hospital - Upper Bucks CampusQuakertown, United StatesContact: Darius C. Desai (principal investigator)Taking people
  • Corewell Health Reed City HospitalReed City, United StatesContact: Andrea GarciaNo longer taking part
  • Renown Regional Medical CenterReno, United StatesContact: Andrea GarciaNo longer taking part
  • VCU Massey Cancer Center at Stony PointRichmond, United StatesContact: Leopoldo J. Fernandez (principal investigator)Taking people
  • VCU Massey Comprehensive Cancer CenterRichmond, United StatesContact: Leopoldo J. Fernandez (principal investigator)Taking people
  • Carilion Roanoke Memorial HospitalRoanoke, United StatesContact: Andrea GarciaNo longer taking part
  • University of RochesterRochester, United StatesContact: Andrea GarciaNo longer taking part
  • Moffitt Cancer Center at SouthShoreRuskin, United StatesContact: Andrea GarciaNo longer taking part
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, United StatesContact: Andrea GarciaNo longer taking part
  • Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, United StatesContact: Andrea GarciaNo longer taking part
  • Sainte Genevieve County Memorial HospitalSainte Genevieve, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • UC San Diego Medical Center - HillcrestSan Diego, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health SandstoneSandstone, United StatesContact: Andrea GarciaNo longer taking part
  • Gulf Health Hospitals Inc/Infirmary Cancer Care - SaralandSaraland, United StatesContact: Andrea GarciaNo longer taking part
  • Fred Hutchinson Cancer CenterSeattle, United StatesContact: Andrea GarciaNo longer taking part
  • University of Washington Medical Center - MontlakeSeattle, United StatesContact: Andrea GarciaNo longer taking part
  • Sanford Cancer Center Oncology ClinicSioux Falls, United StatesContact: Andrea GarciaNo longer taking part
  • Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health-Spooner ClinicSpooner, United StatesContact: Andrea GarciaNo longer taking part
  • Missouri Baptist Medical CenterSt Louis, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Essentia Health - Saint Joseph's Staples ClinicStaples, United StatesContact: Andrea GarciaNo longer taking part
  • Saint Luke's Hospital - Monroe CampusStroudsburg, United StatesContact: Darius C. Desai (principal investigator)Taking people
  • Missouri Baptist Sullivan HospitalSullivan, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • BJC Outpatient Center at Sunset HillsSunset Hills, United StatesContact: Bryan A. Faller (principal investigator)Taking people
  • Essentia Health Saint Mary's Hospital - SuperiorSuperior, United StatesContact: Andrea GarciaNo longer taking part
  • State University of New York Upstate Medical UniversitySyracuse, United StatesContact: Andrea GarciaNo longer taking part
  • Moffitt Cancer Center - McKinley CampusTampa, United StatesContact: Andrew J. Sinnamon (principal investigator)Taking people
  • Moffitt Cancer CenterTampa, United StatesContact: Andrea GarciaNo longer taking part
  • Moffitt Cancer Center-International PlazaTampa, United StatesContact: Andrea GarciaNo longer taking part
  • Essentia Health Virginia ClinicVirginia, United StatesContact: Andrea GarciaNo longer taking part
  • Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesContact: Andrea GarciaNo longer taking part
  • ProHealth Waukesha Memorial HospitalWaukesha, United StatesContact: Andrea GarciaNo longer taking part
  • UW Cancer Center at ProHealth CareWaukesha, United StatesContact: Andrea GarciaNo longer taking part
  • Moffitt Cancer Center at Wesley ChapelWesley Chapel, United StatesContact: Andrea GarciaNo longer taking part
  • University of Cincinnati Cancer Center-West ChesterWest Chester, United StatesContact: Andrea GarciaNo longer taking part
  • Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, United StatesContact: Andrea GarciaNo longer taking part
  • Christiana Care Health System-Wilmington HospitalWilmington, United StatesContact: Andrea GarciaNo longer taking part
  • Valley Health / Winchester Medical CenterWinchester, United StatesContact: Andrea GarciaNo longer taking part
  • University of Michigan Health - WestWyoming, United StatesContact: Andrea GarciaNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm I (lanreotide, distal pancreatectomy)Treatment being tested

    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.

    Treatment: Biospecimen Collection, Distal Pancreatectomy, Lanreotide, and Questionnaire Administration

  • Arm II (saline placebo, distal pancreatectomy)Placebo, for comparison

    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.

    Treatment: Biospecimen Collection, Distal Pancreatectomy, Questionnaire Administration, and Saline

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
Plain-language title
Lanreotide before surgery to prevent a pancreas leak in pancreatic diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 November 2026