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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02757859.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Thomas Jefferson University HospitalStatus: Active
Contact: Harish Lavu
Phone: 215-955-9402
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 versus [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.
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorHarish Lavu