Brief Title
High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery
Official Title
The WASH (Water or Saline at High Volumes) Trial: A Randomized Trial to Assess the Survival Impact of Extensive Peritoneal Lavage Using Distilled WAter or Saline at High Volumes After Pancreatic Resection for Pancreatic Ductal Adenocarcinoma
Brief 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.
Detailed 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) 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.
Study Type
Interventional
Primary Outcome
Overall Survival
Secondary Outcome
Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)
Condition
Acinar Cell Carcinoma
Intervention
Pancreatectomy
Study Arms / Comparison Groups
Arm I (EIPL-S)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
667
Start Date
April 27, 2016
Completion Date
January 2023
Primary Completion Date
April 2022
Eligibility Criteria
Inclusion Criteria: - The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy) - 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 - The subject is willing to consent to randomization of lavage vs. standard lavage Exclusion Criteria: - The subject does not have a surgical indication for pancreatectomy - In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy - The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard - Subject with neoadjuvant chemotherapy or chemoradiation - Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Harish Lavu, MD, 215-955-9402,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02757859
Organization ID
16D.083
Responsible Party
Sponsor
Study Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Sponsor
Harish Lavu, MD, Principal Investigator, Thomas Jefferson University
Verification Date
November 2021