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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
274
Undergo blood sample and pancreas fluid collection
Undergo distal pancreatectomy
Given SC
Ancillary studies
Given SC
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
RECRUITINGMobile Infirmary Medical Center
Mobile, Alabama, United States
RECRUITINGUC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGUSC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
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.
Time frame: Up to 60 days after distal pancreatectomy
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.
Time frame: Up to 60 days after distal pancreatectomy
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.
Time frame: From the time of surgery up to 60 days after distal pancreatectomy
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.
Time frame: At baseline and at 14 and 60 days after surgery
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UC San Diego Medical Center - Hillcrest
San Diego, California, United States
RECRUITINGHelen F Graham Cancer Center
Newark, Delaware, United States
RECRUITINGMedical Oncology Hematology Consultants PA
Newark, Delaware, United States
RECRUITINGChristiana Care Health System-Christiana Hospital
Newark, Delaware, United States
RECRUITINGChristiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
RECRUITINGGrady Health System
Atlanta, Georgia, United States
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