Actively Recruiting
A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula
Led by SWOG Cancer Research Network · Updated on 2026-03-31
274
Participants Needed
118
Research Sites
N/A
Total Duration
On this page
Sponsors
S
SWOG Cancer Research Network
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of lanreotide before surgery compared to surgery alone to prevent pancreatic fistulas in patients with pancreatic cancer or pancreatic lesions that might become cancerous. This phase III trial aims to see if lanreotide, a drug similar to the body's hormone somatostatin and used in certain tumors, can reduce complications like pancreatic fistulas after distal pancreatectomy surgery. Participants are randomly assigned to receive either lanreotide or a saline placebo by a quick injection under the skin within 36 hours before their planned distal pancreatectomy. Blood samples will be taken before surgery and on the first and third days after surgery, with possible collection of pancreatic fluid on these days as well. After surgery, patients will be followed up at 4, 8, and 12 months. During the study, researchers will assess the occurrence of pancreatic fistulas within 60 days after surgery, hospital stay length, and quality of life changes using specific questionnaires. They will also monitor other postoperative complications and the time to start any additional chemotherapy. Blood, pancreatic fluid, and tissue samples will be collected for future research, with all participants monitored carefully throughout the study period.
CONDITIONS
Brief Title
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential
- Participants must have an elective distal pancreatectomy planned within 60 days after registration
- Participants must be 18 years or older
- Participants must have a complete medical history and physical exam within 28 days before registration
- Participants must have acceptable kidney function as defined by creatinine levels or clearance within 60 days before registration
- Participants must not have used any somatostatin analogue within 180 days before registration
- Participants must not have had radiation therapy or peptide receptor radionuclide therapy for their pancreatic condition before registration
- Participants must not require modified Appleby-type or multivisceral resection surgery based on surgeon's opinion
- Participants must not require tumor enucleation based on surgeon's opinion
- Participants must not have moderate to severe liver impairment as defined by specific enzyme levels within 60 days before registration
- Participants must not be pregnant or nursing
- Participants of reproductive potential must agree to use effective contraception during the study and for three months after
- Participants must be offered participation in specimen banking
- Participants able to complete quality-of-life questionnaires in English or Spanish must be offered to participate in this study aspect
- Participants must provide informed consent or have a legally authorized representative consent if applicable
You will not qualify if you...
- History of malabsorption syndrome
- Prior treatment with somatostatin analogues within 180 days before registration
- Prior radiation therapy for pancreatic malignancy
- Prior peptide receptor radionuclide therapy
- Need for modified Appleby-type procedure or multivisceral resection at time of surgery
- Requirement for tumor enucleation based on surgeon's assessment
- Moderate to severe hepatic impairment defined by specific liver enzyme levels
- Pregnancy or nursing status
- Lack of agreement to use contraception if of reproductive potential
- Inability to provide informed consent or absence of legally authorized representative when needed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 3 days (from pre-surgery injection through post-operative sample collection)
Participants receive an injection of lanreotide or saline placebo within 36 hours prior to undergoing distal pancreatectomy surgery. Blood samples are collected immediately before surgery and on post-operative days 1 and 3. Participants may also undergo collection of pancreas fluid on post-operative days 1 and 3.
1 pre-surgery visit and 3 post-operative visits (days 1, 3, and surgery day)
Duration - Up to 60 days after surgery
Participants undergo distal pancreatectomy surgery followed by immediate post-operative care including monitoring for surgical complications.
Visits as part of routine hospital care during the 60 days post-surgery
Duration - 12 months
Participants are followed up at 4, 8, and 12 months after surgery to monitor health status and quality of life.
3 follow-up visits at 4, 8, and 12 months post-surgery
Trial Site Locations
Total: 118 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Suspended
2
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, United States, 36526
Suspended
3
Thomas Hospital
Fairhope, Alabama, United States, 36532
Suspended
4
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
Suspended
5
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, United States, 36571
Suspended
6
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Suspended
7
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Suspended
8
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
9
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, United States, 92357
Suspended
10
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Suspended
11
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Suspended
12
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Suspended
13
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Suspended
14
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Suspended
15
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
Suspended
16
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States, 33570
Suspended
17
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States, 33607
Suspended
18
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States, 33612
Actively Recruiting
19
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Suspended
20
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States, 33544
Suspended
21
Grady Health System
Atlanta, Georgia, United States, 30303
Suspended
22
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Suspended
23
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Suspended
24
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Suspended
25
Emory Johns Creek Hospital
Johns Creek, Georgia, United States, 30097
Suspended
26
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
27
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
28
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Suspended
29
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States, 60523
Suspended
30
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Suspended
31
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Suspended
32
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Suspended
33
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
34
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Suspended
35
Christiana Care - Union Hospital
Elkton, Maryland, United States, 21921
Suspended
36
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Suspended
37
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Suspended
38
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Suspended
39
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Suspended
40
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States, 49503
Suspended
41
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States, 49444
Suspended
42
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States, 49120
Suspended
43
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States, 49444
Suspended
44
Corewell Health Reed City Hospital
Reed City, Michigan, United States, 49677
Suspended
45
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Suspended
46
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, United States, 49085
Suspended
47
University of Michigan Health - West
Wyoming, Michigan, United States, 49519
Suspended
48
Riverwood Healthcare Center
Aitkin, Minnesota, United States, 56431
Suspended
49
Essentia Health - Baxter Clinic
Baxter, Minnesota, United States, 56425
Suspended
50
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Suspended
51
Essentia Health - Saint Joseph's Crosslake Clinic
Crosslake, Minnesota, United States, 56442
Suspended
52
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Suspended
53
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States, 56501
Suspended
54
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Suspended
55
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Suspended
56
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Suspended
57
Essentia Health - Ely Clinic
Ely, Minnesota, United States, 55731
Suspended
58
Essentia Health - Fosston
Fosston, Minnesota, United States, 56542
Suspended
59
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Suspended
60
Essentia Health - International Falls Clinic
International Falls, Minnesota, United States, 56649
Suspended
61
Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota, United States, 55767
Suspended
62
Essentia Health - Park Rapids
Park Rapids, Minnesota, United States, 56470
Suspended
63
Essentia Health - Saint Joseph's Pequot Lakes Clinic
Pequot Lakes, Minnesota, United States, 56472
Suspended
64
Essentia Health - Saint Joseph's Pine River Clinic
Pine River, Minnesota, United States, 56474
Suspended
65
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Suspended
66
Essentia Health - Saint Joseph's Staples Clinic
Staples, Minnesota, United States, 56479
Suspended
67
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Suspended
68
Parkland Health Center - Farmington
Farmington, Missouri, United States, 63640
Actively Recruiting
69
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Actively Recruiting
70
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
Actively Recruiting
71
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Actively Recruiting
72
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States, 63127
Actively Recruiting
73
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Suspended
74
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Suspended
75
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Suspended
76
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Suspended
77
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Suspended
78
University of Rochester
Rochester, New York, United States, 14642
Suspended
79
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Suspended
80
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Suspended
81
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States, 28025
Suspended
82
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Suspended
83
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Suspended
84
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Suspended
85
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, United States, 58401
Suspended
86
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Suspended
87
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Suspended
88
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Suspended
89
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania, United States, 18104
Actively Recruiting
90
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
91
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States, 19317
Suspended
92
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, United States, 18045
Actively Recruiting
93
Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania, United States, 18951
Actively Recruiting
94
Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania, United States, 18360
Actively Recruiting
95
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Suspended
96
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Suspended
97
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Suspended
98
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
Suspended
99
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States, 38120
Suspended
100
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Suspended
101
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Suspended
102
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
103
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
104
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24033
Suspended
105
Valley Health / Winchester Medical Center
Winchester, Virginia, United States, 22601
Suspended
106
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Suspended
107
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Suspended
108
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Suspended
109
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, United States, 54806
Suspended
110
Essentia Health-Hayward Clinic
Hayward, Wisconsin, United States, 54843
Suspended
111
Tamarack Health Hayward Medical Center
Hayward, Wisconsin, United States, 54843
Suspended
112
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
113
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Suspended
114
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Suspended
115
Essentia Health-Spooner Clinic
Spooner, Wisconsin, United States, 54801
Suspended
116
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, United States, 54880
Suspended
117
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Suspended
118
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Suspended
Research Team
A
Andrea Garcia
D
Dana Sparks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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