Lanreotide before surgery to prevent a pancreas leak in pancreatic disease
Tests lanreotide before surgery to prevent leaks in adults with pancreatic tumors.
Plain-language title generated from the registry record
Registry title: Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Key facts
- 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
- Phase
- Phase 3
Where in United States
- Riverwood Healthcare CenterAitkin, United StatesNo longer taking part
- University of New Mexico Cancer CenterAlbuquerque, United StatesNo longer taking part
- Saint Luke's Cancer Center - AllentownAllentown, United StatesTaking people
- University of Michigan Rogel Cancer CenterAnn Arbor, United StatesNo longer taking part
- Duluth Clinic AshlandAshland, United StatesNo longer taking part
- Northwest Wisconsin Cancer CenterAshland, United StatesNo longer taking part
- Emory Saint Joseph's HospitalAtlanta, United StatesNo longer taking part
- Emory University Hospital MidtownAtlanta, United StatesNo longer taking part
- Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesNo longer taking part
- Grady Health SystemAtlanta, United StatesNo longer taking part
- Bronson Battle CreekBattle Creek, United StatesNo longer taking part
- Essentia Health - Baxter ClinicBaxter, United StatesNo longer taking part
- Saint Luke's University Hospital-Bethlehem CampusBethlehem, United StatesTaking people
- University of Alabama at Birmingham Cancer CenterBirmingham, United StatesNo longer taking part
- Essentia Health Saint Joseph's Medical CenterBrainerd, United StatesNo longer taking part
- University of Vermont and State Agricultural CollegeBurlington, United StatesNo longer taking part
- University of Vermont Medical CenterBurlington, United StatesNo longer taking part
- Christiana Care Health System-Concord Health CenterChadds Ford, United StatesNo longer taking part
- Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesTaking people
- University of IllinoisChicago, United StatesTaking people
- University of Cincinnati Cancer Center-UC Medical CenterCincinnati, United StatesNo longer taking part
- Ohio State University Comprehensive Cancer CenterColumbus, United StatesNo longer taking part
- Atrium Health Cabarrus/LCI-ConcordConcord, United StatesNo longer taking part
- Essentia Health - Saint Joseph's Crosslake ClinicCrosslake, United StatesNo longer taking part
- Gulf Health Hospitals Inc/Infirmary Cancer Care - MalbisDaphne, United StatesNo longer taking part
- Essentia Health - Deer River ClinicDeer River, United StatesNo longer taking part
- Essentia Health Saint Mary's - Detroit Lakes ClinicDetroit Lakes, United StatesNo longer taking part
- City of Hope Comprehensive Cancer CenterDuarte, United StatesNo longer taking part
- Essentia Health Cancer CenterDuluth, United StatesNo longer taking part
- Essentia Health Saint Mary's Medical CenterDuluth, United StatesNo longer taking part
- Miller-Dwan HospitalDuluth, United StatesNo longer taking part
- Saint Luke's Hospital-Anderson CampusEaston, United StatesTaking people
- Christiana Care - Union HospitalElkton, United StatesNo longer taking part
- Essentia Health - Ely ClinicEly, United StatesNo longer taking part
- Thomas HospitalFairhope, United StatesNo longer taking part
- Essentia Health Cancer Center-South University ClinicFargo, United StatesNo longer taking part
- Sanford Broadway Medical CenterFargo, United StatesNo longer taking part
- Sanford Roger Maris Cancer CenterFargo, United StatesNo longer taking part
- Parkland Health Center - FarmingtonFarmington, United StatesTaking people
- Essentia Health - FosstonFosston, United StatesNo longer taking part
- Northwestern Medicine Cancer Center DelnorGeneva, United StatesNo longer taking part
- Banner MD Anderson Cancer CenterGilbert, United StatesNo longer taking part
- Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United StatesNo longer taking part
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesNo longer taking part
- Trinity Health Grand Rapids HospitalGrand Rapids, United StatesNo longer taking part
- Essentia Health-Hayward ClinicHayward, United StatesNo longer taking part
- Tamarack Health Hayward Medical CenterHayward, United StatesNo longer taking part
- Essentia Health Hibbing ClinicHibbing, United StatesNo longer taking part
- Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesNo longer taking part
- Essentia Health - International Falls ClinicInternational Falls, United StatesNo longer taking part
- Essentia Health - Jamestown ClinicJamestown, United StatesNo longer taking part
- Emory Johns Creek HospitalJohns Creek, United StatesNo longer taking part
- University of Tennessee - KnoxvilleKnoxville, United StatesNo longer taking part
- UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
- University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
- Saint Barnabas Medical CenterLivingston, United StatesNo longer taking part
- Veterans Affairs Loma Linda Healthcare SystemLoma Linda, United StatesNo longer taking part
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesNo longer taking part
- Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
- Baptist Memorial Hospital and Cancer Center-MemphisMemphis, United StatesNo longer taking part
- Mobile Infirmary Medical CenterMobile, United StatesNo longer taking part
- Essentia Health - Moose Lake ClinicMoose Lake, United StatesNo longer taking part
- ProHealth D N Greenwald CenterMukwonago, United StatesNo longer taking part
- Trinity Health Muskegon HospitalMuskegon, United StatesNo longer taking part
- Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesNo longer taking part
- University Medical Center New OrleansNew Orleans, United StatesNo longer taking part
- Christiana Care Health System-Christiana HospitalNewark, United StatesNo longer taking part
- Helen F Graham Cancer CenterNewark, United StatesNo longer taking part
- Medical Oncology Hematology Consultants PANewark, United StatesNo longer taking part
- Corewell Health Lakeland Hospitals - Niles HospitalNiles, United StatesNo longer taking part
- Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, United StatesNo longer taking part
- Northwestern Medicine Oak BrookOak Brook, United StatesNo longer taking part
- ProHealth Oconomowoc Memorial HospitalOconomowoc, United StatesNo longer taking part
- University of Nebraska Medical CenterOmaha, United StatesNo longer taking part
- Northwestern Medicine Orland ParkOrland Park, United StatesNo longer taking part
- Essentia Health - Park RapidsPark Rapids, United StatesNo longer taking part
- Essentia Health - Saint Joseph's Pequot Lakes ClinicPequot Lakes, United StatesNo longer taking part
- Essentia Health - Saint Joseph's Pine River ClinicPine River, United StatesNo longer taking part
- Saint Luke's Hospital - Upper Bucks CampusQuakertown, United StatesTaking people
- Corewell Health Reed City HospitalReed City, United StatesNo longer taking part
- Renown Regional Medical CenterReno, United StatesNo longer taking part
- VCU Massey Cancer Center at Stony PointRichmond, United StatesTaking people
- VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
- Carilion Roanoke Memorial HospitalRoanoke, United StatesNo longer taking part
- University of RochesterRochester, United StatesNo longer taking part
- Moffitt Cancer Center at SouthShoreRuskin, United StatesNo longer taking part
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, United StatesNo longer taking part
- Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, United StatesNo longer taking part
- Sainte Genevieve County Memorial HospitalSainte Genevieve, United StatesTaking people
- UC San Diego Medical Center - HillcrestSan Diego, United StatesNo longer taking part
- Essentia Health SandstoneSandstone, United StatesNo longer taking part
- Gulf Health Hospitals Inc/Infirmary Cancer Care - SaralandSaraland, United StatesNo longer taking part
- Fred Hutchinson Cancer CenterSeattle, United StatesNo longer taking part
- University of Washington Medical Center - MontlakeSeattle, United StatesNo longer taking part
- Sanford Cancer Center Oncology ClinicSioux Falls, United StatesNo longer taking part
- Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesNo longer taking part
- Essentia Health-Spooner ClinicSpooner, United StatesNo longer taking part
- Missouri Baptist Medical CenterSt Louis, United StatesTaking people
- Essentia Health - Saint Joseph's Staples ClinicStaples, United StatesNo longer taking part
- Saint Luke's Hospital - Monroe CampusStroudsburg, United StatesTaking people
- Missouri Baptist Sullivan HospitalSullivan, United StatesTaking people
- BJC Outpatient Center at Sunset HillsSunset Hills, United StatesTaking people
- Essentia Health Saint Mary's Hospital - SuperiorSuperior, United StatesNo longer taking part
- State University of New York Upstate Medical UniversitySyracuse, United StatesNo longer taking part
- Moffitt Cancer Center - McKinley CampusTampa, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
- Moffitt Cancer Center-International PlazaTampa, United StatesNo longer taking part
- Essentia Health Virginia ClinicVirginia, United StatesNo longer taking part
- Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesNo longer taking part
- ProHealth Waukesha Memorial HospitalWaukesha, United StatesNo longer taking part
- UW Cancer Center at ProHealth CareWaukesha, United StatesNo longer taking part
- Moffitt Cancer Center at Wesley ChapelWesley Chapel, United StatesNo longer taking part
- University of Cincinnati Cancer Center-West ChesterWest Chester, United StatesNo longer taking part
- Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, United StatesNo longer taking part
- Christiana Care Health System-Wilmington HospitalWilmington, United StatesNo longer taking part
- Valley Health / Winchester Medical CenterWinchester, United StatesNo longer taking part
- University of Michigan Health - WestWyoming, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SWOG Cancer Research Network
- Trial code
- NCT06807437
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
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.
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.