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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Resec

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 Summary:

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.


Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Current Primary Outcome: Overall Survival [ Time Frame: Up to 27 months after resection ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Thomas Jefferson University

Dates:
Date Received: April 29, 2016
Date Started: February 2016
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016