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
- Diseases
- Pancreatic cancer
- 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
Sites (118)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Riverwood Healthcare Center Coordinator of this site? Confirm its status | Aitkin | United States | Suspended |
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Suspended |
| Saint Luke's Cancer Center - Allentown Coordinator of this site? Confirm its status | Allentown | United States | Recruiting |
| University of Michigan Rogel Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Suspended |
| Duluth Clinic Ashland Coordinator of this site? Confirm its status | Ashland | United States | Suspended |
| Northwest Wisconsin Cancer Center Coordinator of this site? Confirm its status | Ashland | United States | Suspended |
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Suspended |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Suspended |
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Suspended |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Suspended |
| Bronson Battle Creek Coordinator of this site? Confirm its status | Battle Creek | United States | Suspended |
| Essentia Health - Baxter Clinic Coordinator of this site? Confirm its status | Baxter | United States | Suspended |
| Saint Luke's University Hospital-Bethlehem Campus Coordinator of this site? Confirm its status | Bethlehem | United States | Recruiting |
| University of Alabama at Birmingham Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Suspended |
| Essentia Health Saint Joseph's Medical Center Coordinator of this site? Confirm its status | Brainerd | United States | Suspended |
| University of Vermont Medical Center Coordinator of this site? Confirm its status | Burlington | United States | Suspended |
| University of Vermont and State Agricultural College Coordinator of this site? Confirm its status | Burlington | United States | Suspended |
| Christiana Care Health System-Concord Health Center Coordinator of this site? Confirm its status | Chadds Ford | United States | Suspended |
| Carolinas Medical Center/Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Suspended |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Cincinnati Cancer Center-UC Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Suspended |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Suspended |
| Atrium Health Cabarrus/LCI-Concord Coordinator of this site? Confirm its status | Concord | United States | Suspended |
| Essentia Health - Saint Joseph's Crosslake Clinic Coordinator of this site? Confirm its status | Crosslake | United States | Suspended |
| Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis Coordinator of this site? Confirm its status | Daphne | United States | Suspended |
| Essentia Health - Deer River Clinic Coordinator of this site? Confirm its status | Deer River | United States | Suspended |
| Essentia Health Saint Mary's - Detroit Lakes Clinic Coordinator of this site? Confirm its status | Detroit Lakes | United States | Suspended |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Suspended |
| Essentia Health Saint Mary's Medical Center Coordinator of this site? Confirm its status | Duluth | United States | Suspended |
| Miller-Dwan Hospital Coordinator of this site? Confirm its status | Duluth | United States | Suspended |
| Essentia Health Cancer Center Coordinator of this site? Confirm its status | Duluth | United States | Suspended |
| Saint Luke's Hospital-Anderson Campus Coordinator of this site? Confirm its status | Easton | United States | Recruiting |
| Christiana Care - Union Hospital Coordinator of this site? Confirm its status | Elkton | United States | Suspended |
| Essentia Health - Ely Clinic Coordinator of this site? Confirm its status | Ely | United States | Suspended |
| Thomas Hospital Coordinator of this site? Confirm its status | Fairhope | United States | Suspended |
| Essentia Health Cancer Center-South University Clinic Coordinator of this site? Confirm its status | Fargo | United States | Suspended |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Suspended |
| Sanford Roger Maris Cancer Center Coordinator of this site? Confirm its status | Fargo | United States | Suspended |
| Parkland Health Center - Farmington Coordinator of this site? Confirm its status | Farmington | United States | Recruiting |
| Essentia Health - Fosston Coordinator of this site? Confirm its status | Fosston | United States | Suspended |
| Northwestern Medicine Cancer Center Delnor Coordinator of this site? Confirm its status | Geneva | United States | Suspended |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Suspended |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Suspended |
| Trinity Health Grand Rapids Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Suspended |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Suspended |
| Essentia Health-Hayward Clinic Coordinator of this site? Confirm its status | Hayward | United States | Suspended |
| Tamarack Health Hayward Medical Center Coordinator of this site? Confirm its status | Hayward | United States | Suspended |
| Essentia Health Hibbing Clinic Coordinator of this site? Confirm its status | Hibbing | United States | Suspended |
| Indiana University/Melvin and Bren Simon Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Suspended |
| Essentia Health - International Falls Clinic Coordinator of this site? Confirm its status | International Falls | United States | Suspended |
| Essentia Health - Jamestown Clinic Coordinator of this site? Confirm its status | Jamestown | United States | Suspended |
| Emory Johns Creek Hospital Coordinator of this site? Confirm its status | Johns Creek | United States | Suspended |
| University of Tennessee - Knoxville Coordinator of this site? Confirm its status | Knoxville | United States | Suspended |
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Saint Barnabas Medical Center Coordinator of this site? Confirm its status | Livingston | United States | Suspended |
| Veterans Affairs Loma Linda Healthcare System Coordinator of this site? Confirm its status | Loma Linda | United States | Suspended |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Suspended |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| Baptist Memorial Hospital and Cancer Center-Memphis Coordinator of this site? Confirm its status | Memphis | United States | Suspended |
| Mobile Infirmary Medical Center Coordinator of this site? Confirm its status | Mobile | United States | Suspended |
| Essentia Health - Moose Lake Clinic Coordinator of this site? Confirm its status | Moose Lake | United States | Suspended |
| ProHealth D N Greenwald Center Coordinator of this site? Confirm its status | Mukwonago | United States | Suspended |
| Trinity Health Muskegon Hospital Coordinator of this site? Confirm its status | Muskegon | United States | Suspended |
| Medical Oncology Hematology Consultants PA Coordinator of this site? Confirm its status | Newark | United States | Suspended |
| Christiana Care Health System-Christiana Hospital Coordinator of this site? Confirm its status | Newark | United States | Suspended |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Suspended |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Suspended |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Suspended |
| Corewell Health Lakeland Hospitals - Niles Hospital Coordinator of this site? Confirm its status | Niles | United States | Suspended |
| Cancer and Hematology Centers of Western Michigan - Norton Shores Coordinator of this site? Confirm its status | Norton Shores | United States | Suspended |
| Northwestern Medicine Oak Brook Coordinator of this site? Confirm its status | Oak Brook | United States | Suspended |
| ProHealth Oconomowoc Memorial Hospital Coordinator of this site? Confirm its status | Oconomowoc | United States | Suspended |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Suspended |
| Northwestern Medicine Orland Park Coordinator of this site? Confirm its status | Orland Park | United States | Suspended |
| Essentia Health - Park Rapids Coordinator of this site? Confirm its status | Park Rapids | United States | Suspended |
| Essentia Health - Saint Joseph's Pequot Lakes Clinic Coordinator of this site? Confirm its status | Pequot Lakes | United States | Suspended |
| Essentia Health - Saint Joseph's Pine River Clinic Coordinator of this site? Confirm its status | Pine River | United States | Suspended |
| Saint Luke's Hospital - Upper Bucks Campus Coordinator of this site? Confirm its status | Quakertown | United States | Recruiting |
| Corewell Health Reed City Hospital Coordinator of this site? Confirm its status | Reed City | United States | Suspended |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Suspended |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| VCU Massey Cancer Center at Stony Point Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Carilion Roanoke Memorial Hospital Coordinator of this site? Confirm its status | Roanoke | United States | Suspended |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Suspended |
| Moffitt Cancer Center at SouthShore Coordinator of this site? Confirm its status | Ruskin | United States | Suspended |
| Sainte Genevieve County Memorial Hospital Coordinator of this site? Confirm its status | Sainte Genevieve | United States | Recruiting |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Coordinator of this site? Confirm its status | Saint Joseph | United States | Suspended |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Coordinator of this site? Confirm its status | Saint Joseph | United States | Suspended |
| UC San Diego Medical Center - Hillcrest Coordinator of this site? Confirm its status | San Diego | United States | Suspended |
| Essentia Health Sandstone Coordinator of this site? Confirm its status | Sandstone | United States | Suspended |
| Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland Coordinator of this site? Confirm its status | Saraland | United States | Suspended |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Suspended |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Suspended |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Suspended |
| Sanford Cancer Center Oncology Clinic Coordinator of this site? Confirm its status | Sioux Falls | United States | Suspended |
| Essentia Health-Spooner Clinic Coordinator of this site? Confirm its status | Spooner | United States | Suspended |
| Essentia Health - Saint Joseph's Staples Clinic Coordinator of this site? Confirm its status | Staples | United States | Suspended |
| Missouri Baptist Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Saint Luke's Hospital - Monroe Campus Coordinator of this site? Confirm its status | Stroudsburg | United States | Recruiting |
| Missouri Baptist Sullivan Hospital Coordinator of this site? Confirm its status | Sullivan | United States | Recruiting |
| BJC Outpatient Center at Sunset Hills Coordinator of this site? Confirm its status | Sunset Hills | United States | Recruiting |
| Essentia Health Saint Mary's Hospital - Superior Coordinator of this site? Confirm its status | Superior | United States | Suspended |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Suspended |
| Moffitt Cancer Center - McKinley Campus Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Moffitt Cancer Center-International Plaza Coordinator of this site? Confirm its status | Tampa | United States | Suspended |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Suspended |
| Essentia Health Virginia Clinic Coordinator of this site? Confirm its status | Virginia | United States | Suspended |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Suspended |
| UW Cancer Center at ProHealth Care Coordinator of this site? Confirm its status | Waukesha | United States | Suspended |
| ProHealth Waukesha Memorial Hospital Coordinator of this site? Confirm its status | Waukesha | United States | Suspended |
| Moffitt Cancer Center at Wesley Chapel Coordinator of this site? Confirm its status | Wesley Chapel | United States | Suspended |
| University of Cincinnati Cancer Center-West Chester Coordinator of this site? Confirm its status | West Chester | United States | Suspended |
| Geisinger Wyoming Valley/Henry Cancer Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Suspended |
| Christiana Care Health System-Wilmington Hospital Coordinator of this site? Confirm its status | Wilmington | United States | Suspended |
| Valley Health / Winchester Medical Center Coordinator of this site? Confirm its status | Winchester | United States | Suspended |
| University of Michigan Health - West Coordinator of this site? Confirm its status | Wyoming | United States | Suspended |
This page is information, not medical advice. Discuss any trial with your doctor.