S2408, A RANDOMIZED PHASE III BLINDED TRIAL OF LANREOTIDE FOR THE PREVENTION OF POSTOPERATIVE PANCREATIC FISTULA
Categories (click each to see list of all clinical trials associated with that category): Pancreatic Cancer Center of Excellence - PCCE (ONC), Surgical Oncology (SURGONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Merani, Shaheed
Contact Information:
Mahdi Hassan
mhassan@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06807437?term=NCT06807437&rank=1#participation-criteria
Summary
Primary Objective: 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:
a. 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.
b. To compare the number of postoperative days in the hospital within 60 days after surgery in participants
randomized to receive preoperative lanreotide versus placebo.
c. To compare change from baseline in cancer-specific quality of life at 14 and 60 days after surgery, as measured
by the EORTC QLQ-C30, in participants randomized to receive preoperative lanreotide versus placebo.
Additional Objectives:
a. 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-PAN26 and EQ-5D-5L, in participants
randomized to receive preoperative lanreotide versus placebo.
b. 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.
c. 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 Objectives:
a. To bank blood, pancreas fluid, and tissue specimens for future correlative studies.