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

January 4, 2024 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

845

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Harish Lavu, MD
  • Phone Number: 215-955-9402

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Sidney Kimmel Cancer Center at Thomas Jefferson University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (EIPL-S)
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
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Other Names:
  • Excision of the Pancreas
  • Pancreas Excision
Other: Lavage
Receive EIPL-S
Other Names:
  • Irrigation
  • Wash
Other: Lavage
Receive EIPL-D
Other Names:
  • Irrigation
  • Wash
Active Comparator: Arm II (EIPL-D)
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
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Other Names:
  • Excision of the Pancreas
  • Pancreas Excision
Other: Lavage
Receive EIPL-S
Other Names:
  • Irrigation
  • Wash
Other: Lavage
Receive EIPL-D
Other Names:
  • Irrigation
  • Wash
Sham Comparator: ARM III (NO LAVAGE)
Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.
Procedure: Pancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Other Names:
  • Excision of the Pancreas
  • Pancreas Excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Up to 5 years after resection
Disease Free survival
Time Frame: Up to 5 years after resection
Will use log-rank tests for time-to-event outcomes.
Up to 5 years after resection
Recurrence free survival rate
Time Frame: At 1 year after resection
At 1 year after resection
Site of first recurrence
Time Frame: Up to 5 years after resection
Up to 5 years after resection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of cells in cytologic washing
Time Frame: Up to 5 years
Will be modeled with repeated measures logistic regression using generalized estimating equations methods. Within this model, group differences in change from post-resection to post-lavage will be compared. McNemar's test for paired dichotomous data will be used to compare presence of cells at pre-dissection to post-resection.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Harish Lavu, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2016

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

April 29, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimated)

May 2, 2016

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16D.083
  • NCI-2016-00588 (Other Identifier: National Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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