This randomized clinical trial studies how well high volume washing of the abdomen works in increasing survival after surgery in patients with pancreatic cancer that can be removed by surgery. High volume washings may remove free floating cancers present after surgery and help prolong survival in patients with pancreatic cancer.
PRIMARY OBJECTIVES: I. Overall survival (OS) (18 to 27 months after resection). SECONDARY OBJECTIVES: I. Disease free survival (DFS). II. Complication rate. III. Site of first-recurrence (by site, and distant vs. local). IV. Clearance of malignant cells pre vs. post-lavage. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I (EIPL-S): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal saline (EIPL-S) lavage 10 times over 15 minutes. ARM II (EIPL-D): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal distilled water (EIPL-D) lavage 10 times over 15 minutes. ARM III (NO LAVAGE): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor. After completion of study treatment, patients are followed up every 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
845
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Receive EIPL-S
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Receive EIPL-D
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Case Western Reserve University
Cleveland, Ohio, United States
RECRUITINGSidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGOverall Survival
Will use a one-sided log-rank test to separately compare lavage (EIPL-S or EIPL=D) to no lavage with respect to OS. Assuming the study is not stopped at the interim analyses, the final comparison will be made with an alpha level of 0.02493. Distribution of OS will be estimated using the Kaplan-Meier method. Secondary analyses will use Cox regression to adjust the lavage/no lavage comparison for other baseline patient and/or characteristics known to be associated with OS.
Time frame: Up to 27 months after resection
Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)
Will use chi-square or Fisher's exact test for dichotomous outcomes and Poisson regression for count outcomes.
Time frame: Up to 5 years after resection
Disease Free survival
Will use log-rank tests for time-to-event outcomes.
Time frame: Up to 5 years after resection
Recurrence free survival rate
Time frame: At 1 year after resection
Site of first recurrence
Time frame: Up to 5 years after resection
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