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NCT06807437RecruitingPhase 3

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

A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

Source: ClinicalTrials.gov · Last updated 31 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
274 (estimated)
First submitted
29 Jan 2025
Start date
9 May 2025
Primary completion date
1 Nov 2027
Lead sponsor
SWOG Cancer Research Network
NCT number
NCT06807437

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 274
  • From 9 May 2025 to the primary completion date, 1 Nov 2027
  • 118 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (118)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Riverwood Healthcare Center
Coordinator of this site? Confirm its status
AitkinUnited StatesSuspended
University of New Mexico Cancer Center
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesSuspended
Saint Luke's Cancer Center - Allentown
Coordinator of this site? Confirm its status
AllentownUnited StatesRecruiting
University of Michigan Rogel Cancer Center
Coordinator of this site? Confirm its status
Ann ArborUnited StatesSuspended
Duluth Clinic Ashland
Coordinator of this site? Confirm its status
AshlandUnited StatesSuspended
Northwest Wisconsin Cancer Center
Coordinator of this site? Confirm its status
AshlandUnited StatesSuspended
Grady Health System
Coordinator of this site? Confirm its status
AtlantaUnited StatesSuspended
Emory University Hospital Midtown
Coordinator of this site? Confirm its status
AtlantaUnited StatesSuspended
Emory University Hospital/Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesSuspended
Emory Saint Joseph's Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesSuspended
Bronson Battle Creek
Coordinator of this site? Confirm its status
Battle CreekUnited StatesSuspended
Essentia Health - Baxter Clinic
Coordinator of this site? Confirm its status
BaxterUnited StatesSuspended
Saint Luke's University Hospital-Bethlehem Campus
Coordinator of this site? Confirm its status
BethlehemUnited StatesRecruiting
University of Alabama at Birmingham Cancer Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesSuspended
Essentia Health Saint Joseph's Medical Center
Coordinator of this site? Confirm its status
BrainerdUnited StatesSuspended
University of Vermont Medical Center
Coordinator of this site? Confirm its status
BurlingtonUnited StatesSuspended
University of Vermont and State Agricultural College
Coordinator of this site? Confirm its status
BurlingtonUnited StatesSuspended
Christiana Care Health System-Concord Health Center
Coordinator of this site? Confirm its status
Chadds FordUnited StatesSuspended
Carolinas Medical Center/Levine Cancer Institute
Coordinator of this site? Confirm its status
CharlotteUnited StatesSuspended
University of Illinois
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Cincinnati Cancer Center-UC Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesSuspended
Ohio State University Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesSuspended
Atrium Health Cabarrus/LCI-Concord
Coordinator of this site? Confirm its status
ConcordUnited StatesSuspended
Essentia Health - Saint Joseph's Crosslake Clinic
Coordinator of this site? Confirm its status
CrosslakeUnited StatesSuspended
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Coordinator of this site? Confirm its status
DaphneUnited StatesSuspended
Essentia Health - Deer River Clinic
Coordinator of this site? Confirm its status
Deer RiverUnited StatesSuspended
Essentia Health Saint Mary's - Detroit Lakes Clinic
Coordinator of this site? Confirm its status
Detroit LakesUnited StatesSuspended
City of Hope Comprehensive Cancer Center
Coordinator of this site? Confirm its status
DuarteUnited StatesSuspended
Essentia Health Saint Mary's Medical Center
Coordinator of this site? Confirm its status
DuluthUnited StatesSuspended
Miller-Dwan Hospital
Coordinator of this site? Confirm its status
DuluthUnited StatesSuspended
Essentia Health Cancer Center
Coordinator of this site? Confirm its status
DuluthUnited StatesSuspended
Saint Luke's Hospital-Anderson Campus
Coordinator of this site? Confirm its status
EastonUnited StatesRecruiting
Christiana Care - Union Hospital
Coordinator of this site? Confirm its status
ElktonUnited StatesSuspended
Essentia Health - Ely Clinic
Coordinator of this site? Confirm its status
ElyUnited StatesSuspended
Thomas Hospital
Coordinator of this site? Confirm its status
FairhopeUnited StatesSuspended
Essentia Health Cancer Center-South University Clinic
Coordinator of this site? Confirm its status
FargoUnited StatesSuspended
Sanford Broadway Medical Center
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FargoUnited StatesSuspended
Sanford Roger Maris Cancer Center
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FargoUnited StatesSuspended
Parkland Health Center - Farmington
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FarmingtonUnited StatesRecruiting
Essentia Health - Fosston
Coordinator of this site? Confirm its status
FosstonUnited StatesSuspended
Northwestern Medicine Cancer Center Delnor
Coordinator of this site? Confirm its status
GenevaUnited StatesSuspended
Banner MD Anderson Cancer Center
Coordinator of this site? Confirm its status
GilbertUnited StatesSuspended
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesSuspended
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesSuspended
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesSuspended
Essentia Health-Hayward Clinic
Coordinator of this site? Confirm its status
HaywardUnited StatesSuspended
Tamarack Health Hayward Medical Center
Coordinator of this site? Confirm its status
HaywardUnited StatesSuspended
Essentia Health Hibbing Clinic
Coordinator of this site? Confirm its status
HibbingUnited StatesSuspended
Indiana University/Melvin and Bren Simon Cancer Center
Coordinator of this site? Confirm its status
IndianapolisUnited StatesSuspended
Essentia Health - International Falls Clinic
Coordinator of this site? Confirm its status
International FallsUnited StatesSuspended
Essentia Health - Jamestown Clinic
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JamestownUnited StatesSuspended
Emory Johns Creek Hospital
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Johns CreekUnited StatesSuspended
University of Tennessee - Knoxville
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesSuspended
UC San Diego Moores Cancer Center
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
University of Kentucky/Markey Cancer Center
Coordinator of this site? Confirm its status
LexingtonUnited StatesRecruiting
Saint Barnabas Medical Center
Coordinator of this site? Confirm its status
LivingstonUnited StatesSuspended
Veterans Affairs Loma Linda Healthcare System
Coordinator of this site? Confirm its status
Loma LindaUnited StatesSuspended
USC / Norris Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesSuspended
Marshfield Medical Center-Marshfield
Coordinator of this site? Confirm its status
MarshfieldUnited StatesRecruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Coordinator of this site? Confirm its status
MemphisUnited StatesSuspended
Mobile Infirmary Medical Center
Coordinator of this site? Confirm its status
MobileUnited StatesSuspended
Essentia Health - Moose Lake Clinic
Coordinator of this site? Confirm its status
Moose LakeUnited StatesSuspended
ProHealth D N Greenwald Center
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MukwonagoUnited StatesSuspended
Trinity Health Muskegon Hospital
Coordinator of this site? Confirm its status
MuskegonUnited StatesSuspended
Medical Oncology Hematology Consultants PA
Coordinator of this site? Confirm its status
NewarkUnited StatesSuspended
Christiana Care Health System-Christiana Hospital
Coordinator of this site? Confirm its status
NewarkUnited StatesSuspended
Helen F Graham Cancer Center
Coordinator of this site? Confirm its status
NewarkUnited StatesSuspended
Rutgers Cancer Institute of New Jersey
Coordinator of this site? Confirm its status
New BrunswickUnited StatesSuspended
University Medical Center New Orleans
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New OrleansUnited StatesSuspended
Corewell Health Lakeland Hospitals - Niles Hospital
Coordinator of this site? Confirm its status
NilesUnited StatesSuspended
Cancer and Hematology Centers of Western Michigan - Norton Shores
Coordinator of this site? Confirm its status
Norton ShoresUnited StatesSuspended
Northwestern Medicine Oak Brook
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Oak BrookUnited StatesSuspended
ProHealth Oconomowoc Memorial Hospital
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OconomowocUnited StatesSuspended
University of Nebraska Medical Center
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OmahaUnited StatesSuspended
Northwestern Medicine Orland Park
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Orland ParkUnited StatesSuspended
Essentia Health - Park Rapids
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Park RapidsUnited StatesSuspended
Essentia Health - Saint Joseph's Pequot Lakes Clinic
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Pequot LakesUnited StatesSuspended
Essentia Health - Saint Joseph's Pine River Clinic
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Pine RiverUnited StatesSuspended
Saint Luke's Hospital - Upper Bucks Campus
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QuakertownUnited StatesRecruiting
Corewell Health Reed City Hospital
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Reed CityUnited StatesSuspended
Renown Regional Medical Center
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RenoUnited StatesSuspended
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
VCU Massey Cancer Center at Stony Point
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RichmondUnited StatesRecruiting
Carilion Roanoke Memorial Hospital
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RoanokeUnited StatesSuspended
University of Rochester
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RochesterUnited StatesSuspended
Moffitt Cancer Center at SouthShore
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RuskinUnited StatesSuspended
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint JosephUnited StatesSuspended
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Saint JosephUnited StatesSuspended
UC San Diego Medical Center - Hillcrest
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San DiegoUnited StatesSuspended
Essentia Health Sandstone
Coordinator of this site? Confirm its status
SandstoneUnited StatesSuspended
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
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SaralandUnited StatesSuspended
University of Washington Medical Center - Montlake
Coordinator of this site? Confirm its status
SeattleUnited StatesSuspended
Fred Hutchinson Cancer Center
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SeattleUnited StatesSuspended
Sanford USD Medical Center - Sioux Falls
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesSuspended
Sanford Cancer Center Oncology Clinic
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesSuspended
Essentia Health-Spooner Clinic
Coordinator of this site? Confirm its status
SpoonerUnited StatesSuspended
Essentia Health - Saint Joseph's Staples Clinic
Coordinator of this site? Confirm its status
StaplesUnited StatesSuspended
Missouri Baptist Medical Center
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Saint Luke's Hospital - Monroe Campus
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StroudsburgUnited StatesRecruiting
Missouri Baptist Sullivan Hospital
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SullivanUnited StatesRecruiting
BJC Outpatient Center at Sunset Hills
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Sunset HillsUnited StatesRecruiting
Essentia Health Saint Mary's Hospital - Superior
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SuperiorUnited StatesSuspended
State University of New York Upstate Medical University
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SyracuseUnited StatesSuspended
Moffitt Cancer Center - McKinley Campus
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TampaUnited StatesRecruiting
Moffitt Cancer Center-International Plaza
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TampaUnited StatesSuspended
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesSuspended
Essentia Health Virginia Clinic
Coordinator of this site? Confirm its status
VirginiaUnited StatesSuspended
Northwestern Medicine Cancer Center Warrenville
Coordinator of this site? Confirm its status
WarrenvilleUnited StatesSuspended
UW Cancer Center at ProHealth Care
Coordinator of this site? Confirm its status
WaukeshaUnited StatesSuspended
ProHealth Waukesha Memorial Hospital
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WaukeshaUnited StatesSuspended
Moffitt Cancer Center at Wesley Chapel
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Wesley ChapelUnited StatesSuspended
University of Cincinnati Cancer Center-West Chester
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West ChesterUnited StatesSuspended
Geisinger Wyoming Valley/Henry Cancer Center
Coordinator of this site? Confirm its status
Wilkes-BarreUnited StatesSuspended
Christiana Care Health System-Wilmington Hospital
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WilmingtonUnited StatesSuspended
Valley Health / Winchester Medical Center
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WinchesterUnited StatesSuspended
University of Michigan Health - West
Coordinator of this site? Confirm its status
WyomingUnited StatesSuspended

This page is information, not medical advice. Discuss any trial with your doctor.