NCT02757859

High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery

The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled Water or Saline at High Volumes for Resected Pancreatic Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 845 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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): 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.

Conditions

• Acinar Cell Carcinoma
• Ampulla of Vater Adenocarcinoma
• Cholangiocarcinoma
• Duodenal Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Intraductal Papillary Mucinous Neoplasm
• Periampullary Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Pancreatectomy	Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
OTHER	Lavage	Receive EIPL-S
PROCEDURE	Pancreatectomy	Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
OTHER	Lavage	Receive EIPL-D
PROCEDURE	Pancreatectomy	Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Timeline

• Start date: 2016-04-27
• Primary completion: 2026-04-27
• Completion: 2026-04-27
• First posted: 2016-05-02
• Last updated: 2025-05-20

Locations

2 sites across 1 country: United States