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
2 other identifiers
interventional
845
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 27, 2016
CompletedFirst Submitted
Initial submission to the registry
April 29, 2016
CompletedFirst Posted
Study publicly available on registry
May 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2026
CompletedMay 20, 2025
May 1, 2025
10 years
April 29, 2016
May 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)
Up to 5 years after resection
Disease Free survival
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
Other Outcomes (1)
Presence of cells in cytologic washing
Up to 5 years
Study Arms (3)
Arm I (EIPL-S)
ACTIVE COMPARATORPatients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-S lavage 10 times over 15 minutes.
Arm II (EIPL-D)
ACTIVE COMPARATORPatients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-D lavage 10 times over 15 minutes.
ARM III (NO LAVAGE)
SHAM COMPARATORPatients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.
Interventions
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harish Lavu, MD
Thomas Jefferson University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2016
First Posted
May 2, 2016
Study Start
April 27, 2016
Primary Completion
April 27, 2026
Study Completion
April 27, 2026
Last Updated
May 20, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share