Cholangiocarcinoma Clinical Trial
Official title:
The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled Water or Saline at High Volumes for Resected Pancreatic Cancer
Verified date | January 2024 |
Source | Thomas Jefferson University |
Contact | Harish Lavu, MD |
Phone | 215-955-9402 |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 845 |
Est. completion date | January 2025 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Presence of cells in cytologic washing | 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 | |
Primary | 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 | Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0) | Will use chi-square or Fisher's exact test for dichotomous outcomes and Poisson regression for count outcomes. | Up to 5 years after resection | |
Secondary | Disease Free survival | Will use log-rank tests for time-to-event outcomes. | Up to 5 years after resection | |
Secondary | Recurrence free survival rate | At 1 year after resection | ||
Secondary | Site of first recurrence | Up to 5 years after resection |
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