Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Start Date
5/9/2025
Completion Date
11/1/2027
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. 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.
Detailed Description
PRIMARY OBJECTIVE: I. 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: I. 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: I. 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: I. 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Biospecimen Collection
Distal Pancreatectomy
Lanreotide
Questionnaire Administration
Saline
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama 36526
United States
Thomas Hospital
Fairhope, Alabama 36532
United States
Mobile Infirmary Medical Center
Mobile, Alabama 36607
United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama 36571
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California 92357
United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
UC San Diego Medical Center - Hillcrest
San Diego, California 92103
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
United States
Moffitt Cancer Center at SouthShore
Ruskin, Florida 33570
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida 33544
United States
Grady Health System
Atlanta, Georgia 30303
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Emory Johns Creek Hospital
Johns Creek, Georgia 30097
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois 60523
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Christiana Care - Union Hospital
Elkton, Maryland 21921
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Bronson Battle Creek
Battle Creek, Michigan 49017
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
United States
Corewell Health Reed City Hospital
Reed City, Michigan 49677
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
United States
University of Michigan Health - West
Wyoming, Michigan 49519
United States
Riverwood Healthcare Center
Aitkin, Minnesota 56431
United States
Essentia Health - Baxter Clinic
Baxter, Minnesota 56425
United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
United States
Essentia Health - Saint Joseph's Crosslake Clinic
Crosslake, Minnesota 56442
United States
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
United States
Essentia Health Cancer Center
Duluth, Minnesota 55805
United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota 55805
United States
Miller-Dwan Hospital
Duluth, Minnesota 55805
United States
Essentia Health - Ely Clinic
Ely, Minnesota 55731
United States
Essentia Health - Fosston
Fosston, Minnesota 56542
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
United States
Essentia Health - International Falls Clinic
International Falls, Minnesota 56649
United States
Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota 55767
United States
Essentia Health - Park Rapids
Park Rapids, Minnesota 56470
United States
Essentia Health - Saint Joseph's Pequot Lakes Clinic
Pequot Lakes, Minnesota 56472
United States
Essentia Health - Saint Joseph's Pine River Clinic
Pine River, Minnesota 56474
United States
Essentia Health Sandstone
Sandstone, Minnesota 55072
United States
Essentia Health - Saint Joseph's Staples Clinic
Staples, Minnesota 56479
United States
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
United States
Parkland Health Center - Farmington
Farmington, Missouri 63640
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Missouri Baptist Medical Center
St Louis, Missouri 63131
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Saint Barnabas Medical Center
Livingston, New Jersey 07039
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
University of Rochester
Rochester, New York 14642
United States
State University of New York Upstate Medical University
Syracuse, New York 13210
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
Essentia Health - Jamestown Clinic
Jamestown, North Dakota 58401
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania 18104
United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania 18015
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
United States
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania 18045
United States
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania 18951
United States
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania 18360
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
University of Tennessee - Knoxville
Knoxville, Tennessee 37920
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
University of Vermont and State Agricultural College
Burlington, Vermont 05405
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24033
United States
Valley Health / Winchester Medical Center
Winchester, Virginia 22601
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Duluth Clinic Ashland
Ashland, Wisconsin 54806
United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin 54843
United States
Tamarack Health Hayward Medical Center
Hayward, Wisconsin 54843
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin 54801
United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin 54880
United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United States