WASH Trial: Intraoperative Lavage as a Treatment for Pancreatic Cancer
The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled WAter or Saline at High Volumes for Resected Pancreatic Cancer
The goal of this clinical trial is to learn if a special washing treatment used during surgery can help people with pancreatic cancer live longer. The study includes adults who are having surgery for suspected pancreatic cancer or related cancers in nearby organs (called periampullary cancers).
The main questions it aims to answer are:
- Does the washing treatment improve overall survival (how long patients live)?
- Does it improve how long patients remain cancer-free and reduce cancer recurrence or complications?
The investigators will compare two types of washing treatments and standard care to see if either method improves outcomes.
Participants will:
Be assigned by chance (randomized) before surgery to one of three groups:
- Washing with warm saltwater (saline)
- Washing with sterile water
- No extensive washing (standard care)
Undergo their planned cancer surgery, during which the washing treatment (if assigned) will be performed right after the tumor is removed Be followed over time to monitor survival, cancer recurrence, and any side effects
The investigators estimate the washing treatment could increase average survival from about 18 months to 27 months. To ensure enough patients with confirmed pancreatic cancer are included, about 845 participants will be enrolled over time.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
To compare overall survival (OS) following pancreatic resection between subjects receiving extensive abdominal lavage with saline (EAL-S), extensive abdominal lavage with distilled water (EAL-W), and standard of care without extensive lavage.
SECONDARY OBJECTIVES:
I. Disease-free survival (DFS). II. Complication rate. III. Site of first recurrence (by site and distant versus local recurrence). IV. Clearance of malignant cells pre- versus post-lavage.
STUDY DESIGN:
This is a prospective, randomized, participant-blinded clinical trial evaluating extensive abdominal lavage during pancreatic resection for pancreatic and periampullary malignancies.
Subjects are enrolled preoperatively and randomized prior to entering the operating room. Randomization is stratified by study site and use of neoadjuvant therapy. Subjects are randomized to one of three treatment arms:
Arm I (EAL-S): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy followed immediately after specimen removal by extensive abdominal lavage using 10 liters of warmed 0.9% normal saline administered as ten sequential 1-liter irrigations with aspiration.
Arm II (EAL-W): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy followed immediately after specimen removal by extensive abdominal lavage using 10 liters of warmed distilled water administered as ten sequential 1-liter irrigations with aspiration.
Arm III (Standard of Care/No Extensive Lavage): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy without protocol-directed extensive lavage following specimen removal.
The extensive lavage procedure is performed immediately after specimen removal and generally requires approximately 15 minutes.
A total of 845 subjects were enrolled. Subjects with suspected pancreatic or periampullary malignancy are enrolled preoperatively because definitive diagnosis cannot be established before resection. The primary efficacy analysis population consists of subjects with resected pancreatic cancer according to protocol-defined criteria.
For approximately the first 200 enrolled subjects, cytologic washings are obtained at predefined intraoperative time points (pre-dissection, post-resection, post-lavage, and specimen washing) for correlative analyses evaluating malignant cell clearance. Additional biologic studies may be performed using collected specimens.
Following completion of study treatment, subjects are followed initially at approximately 30 days after surgery and then every 3 months thereafter for survival, recurrence, postoperative outcomes, and adjuvant treatment information for up to 5 years following surgery or until death, whichever occurs first.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Sidney Kimmel Cancer Center at Thomas Jefferson University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The subject has a surgical indication for pancreatectomy (pancreaticoduodenctomy, 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. EAL-W vs. no extensive lavage (SOC)
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 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
Study Plan
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 |
|---|---|
|
Experimental: Arm I: Extensive Abdominal Lavage with Saline (EAL-S)
Participants undergo pancreaticoduodenectomy. Immediately after removal of tumor, participants receive EAL-S with 10 L warmed 0.9% normal saline, delivered as 1 L lavage repeated 10 times over 15 minutes.
|
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Other Names:
Receive EAL-S
Other Names:
Receive EAL-W
Other Names:
|
|
Experimental: Arm II: Extensive Abdominal Lavage with Distilled Water (EAL-W)
Participants undergo pancreaticoduodenectomy. Immediately after removal of tumor, participants receive EAL-W with 10 L warmed distilled water, delivered as 1 L lavage repeated 10 times over 15 minutes.
|
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Other Names:
Receive EAL-S
Other Names:
Receive EAL-W
Other Names:
|
|
Active Comparator: ARM III (NO EXTENSIVE LAVAGE)
Participants undergo pancreaticoduodenectomy with no extensive lavage after removal of tumor.
Standard surgical irrigation, if performed at surgeon discretion, may occur as part of routine care.
|
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Other Names:
|
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 (EAL-S or EAL-W) 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 (DFS)
Time Frame: Up to 5 years after resection
|
Will use log-rank tests for time-to-event outcomes.
|
Up to 5 years after resection
|
|
Site of first recurrence (by site, distant vs local)
Time Frame: Up to 5 years after resection
|
First recurrence site will be categorized by anatomic site and as local versus distant recurrence.
|
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
Collaborators
Investigators
- Principal Investigator: Harish Lavu, MD, Thomas Jefferson University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Carcinoma
- Neoplasms, Ductal, Lobular, and Medullary
- Pancreatic Neoplasms
- Pancreatic Intraductal Neoplasms
- Cholangiocarcinoma
- Carcinoma, Acinar Cell
- Investigative Techniques
- Therapeutics
- Surgical Procedures, Operative
- Physical Therapy Modalities
- Rehabilitation
- Digestive System Surgical Procedures
- Hydrotherapy
- Therapeutic Irrigation
- Pancreatectomy
Other Study ID Numbers
- 16D.083
- JT 6902 (Other Identifier: JeffTrial Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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