The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled Water or Saline at High Volumes for Resected Pancreatic Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy) as determined by the treating physician/surgeon * A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively * In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy * Age ≥18 years of age. * The subject is willing to consent to randomization of EAL-S vs. standard EAL-W vs. no extensive lavage. (SOC) Exclusion Criteria: * The subject does not have a surgical indication for pancrea…
Interventions
- ProcedurePancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
- OtherLavage
Receive EIPL-S
- ProcedurePancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
- OtherLavage
Receive EIPL-D
- ProcedurePancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Locations (2)
- Case Western Reserve UniversityCleveland, Ohio
- Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphia, Pennsylvania