Can a simple injection before surgery stop dangerous pancreatic leaks?

NCT ID NCT06807437

Prevention Sponsor: SWOG Cancer Research Network Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if giving the drug lanreotide before pancreatic surgery can prevent a common complication called a pancreatic fistula, which is a leak of digestive fluids. About 274 people with pancreatic cancer or precancerous lesions will be randomly assigned to receive either lanreotide or a placebo before their surgery. The goal is to see if the drug reduces the risk of this serious leak.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 274 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

exocrine pancreatic carcinoma malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic carcinoma Pancreatic neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

118 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Atrium Health Cabarrus/LCI-Concord
SUSPENDED

Concord, North Carolina, 28025, United States
BJC Outpatient Center at Sunset Hills
RECRUITING

Sunset Hills, Missouri, 63127, United States
Banner MD Anderson Cancer Center
SUSPENDED

Gilbert, Arizona, 85234, United States
Baptist Memorial Hospital and Cancer Center-Memphis
SUSPENDED

Memphis, Tennessee, 38120, United States
Bronson Battle Creek
SUSPENDED

Battle Creek, Michigan, 49017, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
SUSPENDED

Norton Shores, Michigan, 49444, United States
Carilion Roanoke Memorial Hospital
SUSPENDED

Roanoke, Virginia, 24033, United States
Carolinas Medical Center/Levine Cancer Institute
SUSPENDED

Charlotte, North Carolina, 28203, United States
Christiana Care - Union Hospital
SUSPENDED

Elkton, Maryland, 21921, United States
Christiana Care Health System-Christiana Hospital
SUSPENDED

Newark, Delaware, 19718, United States
Christiana Care Health System-Concord Health Center
SUSPENDED

Chadds Ford, Pennsylvania, 19317, United States
Christiana Care Health System-Wilmington Hospital
SUSPENDED

Wilmington, Delaware, 19801, United States
City of Hope Comprehensive Cancer Center
SUSPENDED

Duarte, California, 91010, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
SUSPENDED

Grand Rapids, Michigan, 49503, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
SUSPENDED

Grand Rapids, Michigan, 49503, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
SUSPENDED

Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Niles Hospital
SUSPENDED

Niles, Michigan, 49120, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
SUSPENDED

Saint Joseph, Michigan, 49085, United States
Corewell Health Reed City Hospital
SUSPENDED

Reed City, Michigan, 49677, United States
Duluth Clinic Ashland
SUSPENDED

Ashland, Wisconsin, 54806, United States
Emory Johns Creek Hospital
SUSPENDED

Johns Creek, Georgia, 30097, United States
Emory Saint Joseph's Hospital
SUSPENDED

Atlanta, Georgia, 30342, United States
Emory University Hospital Midtown
SUSPENDED

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
SUSPENDED

Atlanta, Georgia, 30322, United States
Essentia Health - Baxter Clinic
SUSPENDED

Baxter, Minnesota, 56425, United States
Essentia Health - Deer River Clinic
SUSPENDED

Deer River, Minnesota, 56636, United States
Essentia Health - Ely Clinic
SUSPENDED

Ely, Minnesota, 55731, United States
Essentia Health - Fosston
SUSPENDED

Fosston, Minnesota, 56542, United States
Essentia Health - International Falls Clinic
SUSPENDED

International Falls, Minnesota, 56649, United States
Essentia Health - Jamestown Clinic
SUSPENDED

Jamestown, North Dakota, 58401, United States
Essentia Health - Moose Lake Clinic
SUSPENDED

Moose Lake, Minnesota, 55767, United States
Essentia Health - Park Rapids
SUSPENDED

Park Rapids, Minnesota, 56470, United States
Essentia Health - Saint Joseph's Crosslake Clinic
SUSPENDED

Crosslake, Minnesota, 56442, United States
Essentia Health - Saint Joseph's Pequot Lakes Clinic
SUSPENDED

Pequot Lakes, Minnesota, 56472, United States
Essentia Health - Saint Joseph's Pine River Clinic
SUSPENDED

Pine River, Minnesota, 56474, United States
Essentia Health - Saint Joseph's Staples Clinic
SUSPENDED

Staples, Minnesota, 56479, United States
Essentia Health Cancer Center
SUSPENDED

Duluth, Minnesota, 55805, United States
Essentia Health Cancer Center-South University Clinic
SUSPENDED

Fargo, North Dakota, 58103, United States
Essentia Health Hibbing Clinic
SUSPENDED

Hibbing, Minnesota, 55746, United States
Essentia Health Saint Joseph's Medical Center
SUSPENDED

Brainerd, Minnesota, 56401, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
SUSPENDED

Detroit Lakes, Minnesota, 56501, United States
Essentia Health Saint Mary's Hospital - Superior
SUSPENDED

Superior, Wisconsin, 54880, United States
Essentia Health Saint Mary's Medical Center
SUSPENDED

Duluth, Minnesota, 55805, United States
Essentia Health Sandstone
SUSPENDED

Sandstone, Minnesota, 55072, United States
Essentia Health Virginia Clinic
SUSPENDED

Virginia, Minnesota, 55792, United States
Essentia Health-Hayward Clinic
SUSPENDED

Hayward, Wisconsin, 54843, United States
Essentia Health-Spooner Clinic
SUSPENDED

Spooner, Wisconsin, 54801, United States
Fred Hutchinson Cancer Center
SUSPENDED

Seattle, Washington, 98109, United States
Geisinger Wyoming Valley/Henry Cancer Center
SUSPENDED

Wilkes-Barre, Pennsylvania, 18711, United States
Grady Health System
SUSPENDED

Atlanta, Georgia, 30303, United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
SUSPENDED

Daphne, Alabama, 36526, United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
SUSPENDED

Saraland, Alabama, 36571, United States
Helen F Graham Cancer Center
SUSPENDED

Newark, Delaware, 19713, United States
Indiana University/Melvin and Bren Simon Cancer Center
SUSPENDED

Indianapolis, Indiana, 46202, United States
Marshfield Medical Center-Marshfield
RECRUITING

Marshfield, Wisconsin, 54449, United States

Contact Email: •••••@•••••
Medical Oncology Hematology Consultants PA
SUSPENDED

Newark, Delaware, 19713, United States
Miller-Dwan Hospital
SUSPENDED

Duluth, Minnesota, 55805, United States
Missouri Baptist Medical Center
RECRUITING

St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital
RECRUITING

Sullivan, Missouri, 63080, United States
Mobile Infirmary Medical Center
SUSPENDED

Mobile, Alabama, 36607, United States
Moffitt Cancer Center
SUSPENDED

Tampa, Florida, 33612, United States
Moffitt Cancer Center - McKinley Campus
RECRUITING

Tampa, Florida, 33612, United States

Contact Email: •••••@•••••
Moffitt Cancer Center at SouthShore
SUSPENDED

Ruskin, Florida, 33570, United States
Moffitt Cancer Center at Wesley Chapel
SUSPENDED

Wesley Chapel, Florida, 33544, United States
Moffitt Cancer Center-International Plaza
SUSPENDED

Tampa, Florida, 33607, United States
Northwest Wisconsin Cancer Center
SUSPENDED

Ashland, Wisconsin, 54806, United States
Northwestern Medicine Cancer Center Delnor
SUSPENDED

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Warrenville
SUSPENDED

Warrenville, Illinois, 60555, United States
Northwestern Medicine Oak Brook
SUSPENDED

Oak Brook, Illinois, 60523, United States
Northwestern Medicine Orland Park
SUSPENDED

Orland Park, Illinois, 60462, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States

Contact Email: •••••@•••••
Ohio State University Comprehensive Cancer Center
SUSPENDED

Columbus, Ohio, 43210, United States
Parkland Health Center - Farmington
RECRUITING

Farmington, Missouri, 63640, United States
ProHealth D N Greenwald Center
SUSPENDED

Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital
SUSPENDED

Oconomowoc, Wisconsin, 53066, United States
ProHealth Waukesha Memorial Hospital
SUSPENDED

Waukesha, Wisconsin, 53188, United States
Renown Regional Medical Center
SUSPENDED

Reno, Nevada, 89502, United States
Riverwood Healthcare Center
SUSPENDED

Aitkin, Minnesota, 56431, United States
Rutgers Cancer Institute of New Jersey
SUSPENDED

New Brunswick, New Jersey, 08903, United States
Saint Barnabas Medical Center
SUSPENDED

Livingston, New Jersey, 07039, United States
Saint Luke's Cancer Center - Allentown
RECRUITING

Allentown, Pennsylvania, 18104, United States
Saint Luke's Hospital - Monroe Campus
RECRUITING

Stroudsburg, Pennsylvania, 18360, United States
Saint Luke's Hospital - Upper Bucks Campus
RECRUITING

Quakertown, Pennsylvania, 18951, United States
Saint Luke's Hospital-Anderson Campus
RECRUITING

Easton, Pennsylvania, 18045, United States
Saint Luke's University Hospital-Bethlehem Campus
RECRUITING

Bethlehem, Pennsylvania, 18015, United States
Sainte Genevieve County Memorial Hospital
RECRUITING

Sainte Genevieve, Missouri, 63670, United States
Sanford Broadway Medical Center
SUSPENDED

Fargo, North Dakota, 58122, United States
Sanford Cancer Center Oncology Clinic
SUSPENDED

Sioux Falls, South Dakota, 57104, United States
Sanford Roger Maris Cancer Center
SUSPENDED

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center - Sioux Falls
SUSPENDED

Sioux Falls, South Dakota, 57117-5134, United States
State University of New York Upstate Medical University
SUSPENDED

Syracuse, New York, 13210, United States
Tamarack Health Hayward Medical Center
SUSPENDED

Hayward, Wisconsin, 54843, United States
Thomas Hospital
SUSPENDED

Fairhope, Alabama, 36532, United States
Trinity Health Grand Rapids Hospital
SUSPENDED

Grand Rapids, Michigan, 49503, United States
Trinity Health Muskegon Hospital
SUSPENDED

Muskegon, Michigan, 49444, United States
UC San Diego Medical Center - Hillcrest
SUSPENDED

San Diego, California, 92103, United States
UC San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92093, United States

Contact Email: •••••@•••••
USC / Norris Comprehensive Cancer Center
SUSPENDED

Los Angeles, California, 90033, United States
UW Cancer Center at ProHealth Care
SUSPENDED

Waukesha, Wisconsin, 53188, United States
University Medical Center New Orleans
SUSPENDED

New Orleans, Louisiana, 70112, United States
University of Alabama at Birmingham Cancer Center
SUSPENDED

Birmingham, Alabama, 35233, United States
University of Cincinnati Cancer Center-UC Medical Center
SUSPENDED

Cincinnati, Ohio, 45219, United States
University of Cincinnati Cancer Center-West Chester
SUSPENDED

West Chester, Ohio, 45069, United States
University of Illinois
RECRUITING

Chicago, Illinois, 60612, United States
University of Kentucky/Markey Cancer Center
RECRUITING

Lexington, Kentucky, 40536, United States
University of Michigan Health - West
SUSPENDED

Wyoming, Michigan, 49519, United States
University of Michigan Rogel Cancer Center
SUSPENDED

Ann Arbor, Michigan, 48109, United States
University of Nebraska Medical Center
SUSPENDED

Omaha, Nebraska, 68198, United States
University of New Mexico Cancer Center
SUSPENDED

Albuquerque, New Mexico, 87106, United States
University of Rochester
SUSPENDED

Rochester, New York, 14642, United States
University of Tennessee - Knoxville
SUSPENDED

Knoxville, Tennessee, 37920, United States
University of Vermont Medical Center
SUSPENDED

Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
SUSPENDED

Burlington, Vermont, 05405, United States
University of Washington Medical Center - Montlake
SUSPENDED

Seattle, Washington, 98195, United States
VCU Massey Cancer Center at Stony Point
RECRUITING

Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
RECRUITING

Richmond, Virginia, 23298, United States
Valley Health / Winchester Medical Center
SUSPENDED

Winchester, Virginia, 22601, United States
Veterans Affairs Loma Linda Healthcare System
SUSPENDED

Loma Linda, California, 92357, United States

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