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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Pancreatectomy
* Other: Lavage
* Procedure: Pancreatectomy
* Other: Lavage
* Procedure: Pancreatectomy


Participation Criteria
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Eligibility Criteria
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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 Age < 18 years of age The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors Other malignancy within five years, unless the probability of recurrence of the prior malignancy is < 5% as determined by the principal investigator based on available information; patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study Evidence of metastatic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (EIPL-S)<br>Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-S lavage 10 times over 15 minutes. | Procedure: Pancreatectomy<br>* Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy<br>* Other names: Pancreas Excision;Other: Lavage<br>* Receive EIPL-S<br>* Other names: Wash;|
| Active Comparator: Arm II (EIPL-D)<br>Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-D lavage 10 times over 15 minutes. | Procedure: Pancreatectomy<br>* Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy<br>* Other names: Pancreas Excision;Other: Lavage<br>* Receive EIPL-D<br>* Other names: Wash;|
| Sham Comparator: ARM III (NO LAVAGE)<br>Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor. | Procedure: Pancreatectomy<br>* Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy<br>* Other names: Pancreas Excision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Will use a one-sided log-rank test to separately compare lavage (EIPL-S or EIPL=D) to no lavage with respect to OS. Assuming the study is not stopped at the interim analyses, the final comparison will be made with an alpha level of 0.02493. Distribution of OS will be estimated using the Kaplan-Meier method. Secondary analyses will use Cox regression to adjust the lavage/no lavage comparison for other baseline patient and/or characteristics known to be associated with OS. | Up to 27 months after resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0) | Will use chi-square or Fisher's exact test for dichotomous outcomes and Poisson regression for count outcomes. | Up to 5 years after resection | 
| Disease Free survival | Will use log-rank tests for time-to-event outcomes. | Up to 5 years after resection | 
| Recurrence free survival rate |  | At 1 year after resection | 
| Site of first recurrence |  | Up to 5 years after resection |