Acinar Cell Carcinoma, Ampulla of Vater Adenocarcinoma, Cholangiocarcinoma, Duodenal Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Intraductal Papillary Mucinous Neoplasm, Periampullary Adenocarcinoma
Conditions
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.
Detailed description
PRIMARY OBJECTIVES: I. Overall survival (OS) (18 to 27 months after resection). SECONDARY OBJECTIVES: I. Disease free survival (DFS). II. Complication rate. III. Site of first-recurrence (by site, and distant vs. local). IV. Clearance of malignant cells pre vs. post-lavage. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I (EIPL-S): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal saline (EIPL-S) lavage 10 times over 15 minutes. ARM II (EIPL-D): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal distilled water (EIPL-D) lavage 10 times over 15 minutes. ARM III (NO LAVAGE): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor. After completion of study treatment, patients are followed up every 3 months.
Interventions
PROCEDUREPancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
OTHERLavage
Receive EIPL-S
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 27 months after resection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Will use chi-square or Fisher's exact test for dichotomous outcomes and Poisson regression for count outcomes. |
| Disease Free survival | Up to 5 years after resection | Will use log-rank tests for time-to-event outcomes. |
| Recurrence free survival rate | At 1 year after resection | — |
| Site of first recurrence | Up to 5 years after resection | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Presence of cells in cytologic washing | 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. |
Countries
United States
Contacts
Primary ContactHarish Lavu, MD
Outcome results
None listed