WASH Trial: Intraoperative Lavage as a Treatment for Pancreatic Cancer (NCT02757859) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
WASH Trial: Intraoperative Lavage as a Treatment for Pancreatic Cancer
United States845 participantsStarted 2016-04-27
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival
Timeframe: Up to 27 months after resection
Trial details
NCT IDNCT02757859
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University