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AzTrials

Pancreatic CarcinomaPhase 3NCT06807437

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

A Phase 3 study testing Biospecimen Collection, Distal Pancreatectomy and Lanreotide in people with Pancreatic Carcinoma and Pancreatic Neoplasm, run by SWOG Cancer Research Network at 118 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Carcinoma, Pancreatic Neoplasm
What is being tested?
Biospecimen Collection, Distal Pancreatectomy and Lanreotide
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
274 participants
Where
118 sitesUnited States
Study dates
9 May 2025to 1 Apr 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

118 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Garcia contact

210-614-8808

agarcia@swog.org

Dana Sparks contact

210-614-8808

dsparks@swog.org

118 sites in 1 country

United States118 sites, 18 recruiting

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

    Suspended

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Suspended

  • Saint Luke's Cancer Center - Allentown

    Allentown, Pennsylvania, 18104

    Site Public Contact, 610-776-4714

    Darius C. Desai

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Suspended

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Suspended

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Suspended

  • Grady Health System

    Atlanta, Georgia, 30303

    Suspended

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Suspended

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Suspended

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Suspended

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Suspended

  • Essentia Health - Baxter Clinic

    Baxter, Minnesota, 56425

    Suspended

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

    Site Public Contact, 484-503-4151

    Darius C. Desai

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Suspended

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Suspended

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Suspended

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Suspended

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Suspended

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Suspended

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Akhil Chawla

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Aslam Ejaz

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Suspended

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Suspended

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Suspended

  • Essentia Health - Saint Joseph's Crosslake Clinic

    Crosslake, Minnesota, 56442

    Suspended

  • Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis

    Daphne, Alabama, 36526

    Suspended

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Suspended

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

    Suspended

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Suspended

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Suspended

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

    Suspended

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Suspended

  • Saint Luke's Hospital-Anderson Campus

    Easton, Pennsylvania, 18045

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Darius C. Desai

    Recruiting

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

    Suspended

  • Essentia Health - Ely Clinic

    Ely, Minnesota, 55731

    Suspended

  • Thomas Hospital

    Fairhope, Alabama, 36532

    Suspended

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Suspended

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Suspended

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Suspended

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

    Suspended

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Suspended

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Suspended

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Suspended

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Suspended

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Suspended

  • Essentia Health-Hayward Clinic

    Hayward, Wisconsin, 54843

    Suspended

  • Tamarack Health Hayward Medical Center

    Hayward, Wisconsin, 54843

    Suspended

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Suspended

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Suspended

  • Essentia Health - International Falls Clinic

    International Falls, Minnesota, 56649

    Suspended

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

    Suspended

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

    Suspended

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

    Suspended

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Andrew M. Lowy

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Michael J. Cavnar

    Recruiting

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

    Suspended

  • Veterans Affairs Loma Linda Healthcare System

    Loma Linda, California, 92357

    Suspended

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Suspended

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Jessica A. Wernberg

    Recruiting

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

    Suspended

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

    Suspended

  • Essentia Health - Moose Lake Clinic

    Moose Lake, Minnesota, 55767

    Suspended

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

    Suspended

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

    Suspended

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Suspended

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Suspended

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Suspended

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Suspended

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

    Suspended

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

    Suspended

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

    Suspended

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Suspended

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

    Suspended

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Suspended

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Suspended

  • Essentia Health - Park Rapids

    Park Rapids, Minnesota, 56470

    Suspended

  • Essentia Health - Saint Joseph's Pequot Lakes Clinic

    Pequot Lakes, Minnesota, 56472

    Suspended

  • Essentia Health - Saint Joseph's Pine River Clinic

    Pine River, Minnesota, 56474

    Suspended

  • Saint Luke's Hospital - Upper Bucks Campus

    Quakertown, Pennsylvania, 18951

    Site Public Contact, 610-776-4714

    Darius C. Desai

    Recruiting

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

    Suspended

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Suspended

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

    Site Public Contact, ctoclinops@vcu.edu

    Leopoldo J. Fernandez

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Leopoldo J. Fernandez

    Recruiting

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24033

    Suspended

  • University of Rochester

    Rochester, New York, 14642

    Suspended

  • Moffitt Cancer Center at SouthShore

    Ruskin, Florida, 33570

    Suspended

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

    Suspended

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

    Suspended

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Suspended

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

    Suspended

  • Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland

    Saraland, Alabama, 36571

    Suspended

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Suspended

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

    Suspended

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

    Suspended

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Suspended

  • Essentia Health-Spooner Clinic

    Spooner, Wisconsin, 54801

    Suspended

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Essentia Health - Saint Joseph's Staples Clinic

    Staples, Minnesota, 56479

    Suspended

  • Saint Luke's Hospital - Monroe Campus

    Stroudsburg, Pennsylvania, 18360

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Darius C. Desai

    Recruiting

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • BJC Outpatient Center at Sunset Hills

    Sunset Hills, Missouri, 63127

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Essentia Health Saint Mary's Hospital - Superior

    Superior, Wisconsin, 54880

    Suspended

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

    Suspended

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

    Suspended

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Andrew J. Sinnamon

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Suspended

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

    Suspended

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Suspended

  • ProHealth Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

    Suspended

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

    Suspended

  • Moffitt Cancer Center at Wesley Chapel

    Wesley Chapel, Florida, 33544

    Suspended

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

    Suspended

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

    Suspended

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

    Suspended

  • Valley Health / Winchester Medical Center

    Winchester, Virginia, 22601

    Suspended

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

    Suspended

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the incidence of postoperative pancreatic fistula (POPF) occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm.

SECONDARY OBJECTIVES:

  1. To compare the incidence of International Study Group of Pancreatic Surgery (ISGPS)-defined biochemical leak occurring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo in the subset of participants with a drain placed.

II. To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo.

III. To compare change from baseline in cancer-specific quality of life at 14 and 60 days after surgery, as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30-(C30), in participants randomized to receive preoperative lanreotide versus placebo.

ADDITIONAL OBJECTIVES:

  1. To compare change from baseline in pancreatic cancer-specific quality of life and overall health-related quality of life at 14 and 60 days after surgery, as measured by the EORTC QLQ- Pancreatic Cancer 26 (PAN26) and European Quality of Life Five Dimension Five Level (EQ-5D-5L), in participants randomized to receive preoperative lanreotide versus placebo.

II. To compare the proportions of participants with common postoperative sequelae associated with POPF, including ISGPS delayed gastric emptying and ISGPS post pancreatectomy hemorrhage (grades B/C) occurring within 60 days after surgery, in participants randomized to receive preoperative lanreotide versus placebo.

III. To compare time from surgery to initiation of adjuvant chemotherapy among participants with pancreatic ductal adenocarcinoma and planned adjuvant chemotherapy randomized to receive preoperative lanreotide versus placebo.

BANKING OBJECTIVE:

  1. To bank blood, pancreas fluid, and tissue specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive lanreotide subcutaneously (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.

ARM II: 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.

After completion of study treatment, patients are followed up at 4, 8 and 12 months after surgery.

Being tested
Biospecimen Collection, Distal Pancreatectomy, Lanreotide, Questionnaire Administration, Saline
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample and pancreas fluid collection

  • Distal PancreatectomyProcedure or surgery

    Undergo distal pancreatectomy

  • LanreotideDrug

    Also called Angiopeptin, BIM-23014, DC 13116, Dermopeptin

    Given SC

  • Questionnaire AdministrationOther

    Ancillary studies

  • SalineOther

    Also called ISOTONIC SODIUM CHLORIDE SOLUTION, Normal Saline, Sodium Chloride 0.9%

    Given SC

Study groups in NCT06807437
Study groupRoleWhat they receive
Arm I (lanreotide, distal pancreatectomy)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Distal Pancreatectomy; Drug: Lanreotide; Other: Questionnaire Administration
Arm II (saline placebo, distal pancreatectomy)Placebo comparatorPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Distal Pancreatectomy; Other: Questionnaire Administration; Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postoperative pancreatic fistula (POPF)

    POPF will be assessed using the 2016 International Study Group for Pancreas Surgery (ISGPS). Incidence rates of POPF in each treatment arm will be described, and treatment arm differences assessed via logistic regression model with adjustment for stratification factor.

    Measured: Up to 60 days after distal pancreatectomy

Secondary outcomes (3)

  1. Incidence of biochemical leak (BL)

    BL will be defined by the ISGPS as a peritoneal drain amylase greater than three times the upper limit of the institutional normal serum amylase without an effect on clinical management or duration of hospital stay. BL will only be measured in those who had a peritoneal drain placed. Treatment arm differences will be assessed via logistic regression model with adjustment for stratification factor.

    Measured: Up to 60 days after distal pancreatectomy

  2. Number of post-operation hospital days

    Mean hospital length of stay will be compared according to treatment arm via linear regression model with adjustment for stratification factor.

    Measured: From the time of surgery up to 60 days after distal pancreatectomy

  3. Change in overall quality of life (QOL)

    Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Core 30 (C30). Treatment arm differences in EORTC QLQ-C30 changes will be assessed by repeated measures linear regression model as a function of randomization assignment, baseline score, stratification factor, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures.

    Measured: At baseline and at 14 and 60 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start9 May 2025
  3. Primary completion1 Apr 2029 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
274 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807437
Sponsor's protocol ID
S2408
Other IDs
NCI-2024-08361, S2408, SWOG-S2408, S2408, UG1CA189974
Status last verified
Nov 2026
First submitted
29 Jan 2025
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Intara AS, Guthrie KA, Chauhan SSB, Arnold KB, Topacio R, Carvalho K, Garcia A, Fraser V, Wright GP, Sun V, Ahmad SA, Rocha FG, Chiorean EG, Philip P, Ecker BL, Reames BN, Karanicolas P, Krouse RS, Pillarisetty VG, Sham JG. Lanreotide for the prevention of postoperative pancreatic fistula (S2408): study protocol for a multicenter randomized controlled trial. Trials. 2026 Aug 3;27(1):634. doi: 10.1186/s13063-026-09933-8.

    PubMed 42958416

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biospecimen Collection, Distal Pancreatectomy and Lanreotide in people with Pancreatic Carcinoma and Pancreatic Neoplasm, run by SWOG Cancer Research Network at 118 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Garcia (210-614-8808, agarcia@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative pancreatic fistula (POPF) (time frame: Up to 60 days after distal pancreatectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06807437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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