High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acinar Cell Carcinoma
- Ampulla of Vater Adenocarcinoma
- Cholangiocarcinoma
- Duodenal Adenocarcinoma
- Pancreatic Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma
- Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type
- Periampullary Adenocarcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ran...
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) extensive intraoperative peritoneal saline lavage: 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) extensive intraoperative peritoneal distilled water lavage: 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.
Tracking Information
- NCT #
- NCT02757859
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Harish Lavu, MD Thomas Jefferson University
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