High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery
- Conditions
- Ampulla of Vater AdenocarcinomaCholangiocarcinomaDuodenal AdenocarcinomaAcinar Cell CarcinomaPancreatic AdenocarcinomaPancreatic Ductal AdenocarcinomaPancreatic Intraductal Papillary Mucinous NeoplasmPeriampullary Adenocarcinoma
- Registration Number
- NCT02757859
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 845
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
Site of first recurrence Up to 5 years after resection
Related Research Topics
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Trial Locations
- Locations (2)
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Case Western Reserve University🇺🇸Cleveland, Ohio, United StatesJordan Winter, MDContact216-844-5777jordan.winter@UHhospitals.org