High volume washing of the abdomen to improve survival after pancreatic cancer surgery
The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled Water or Saline at High Volumes for Resected Pancreatic Cancer
This study is testing if washing the abdomen with different solutions during pancreatic cancer surgery can help patients live longer and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 845 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT02757859 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of high volume washing of the abdomen during surgery for patients with resectable pancreatic cancer. Participants are randomized into three groups: one receiving extensive saline lavage, another receiving distilled water lavage, and a control group with no lavage after tumor removal. The primary objective is to assess overall survival, while secondary objectives include disease-free survival, complication rates, and the clearance of malignant cells. Patients will be monitored for 18 to 27 months post-surgery to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a surgical indication for pancreatectomy due to pancreatic or periampullary cancer.
Not a fit: Patients with benign pancreatic conditions or those with medical contraindications to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients undergoing surgery for pancreatic cancer.
How similar studies have performed: While this approach is innovative, similar studies exploring intraoperative lavage techniques have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) 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.
Where this trial is running
Cleveland, Ohio and 1 other locations
- Case Western Reserve University — Cleveland, Ohio, United States (Recruiting)
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Harish Lavu, MD — Thomas Jefferson University
- Study coordinator: Harish Lavu, MD
- Phone: 215-955-9402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.