RecruitingNot ApplicableNCT02757859

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Enrollment

845 participants

Start Date

Apr 27, 2016

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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 EAL-S vs. EAL-W vs. no extensive lavage (SOC)
Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors) without possible risk of malignancy
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 preoperatively.