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High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery

Not Applicable
Recruiting
Conditions
Ampulla of Vater Adenocarcinoma
Cholangiocarcinoma
Duodenal Adenocarcinoma
Acinar Cell Carcinoma
Pancreatic Adenocarcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Intraductal Papillary Mucinous Neoplasm
Periampullary Adenocarcinoma
Registration Number
NCT02757859
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Overall SurvivalUp 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
NameTimeMethod
Disease Free survivalUp to 5 years after resection

Will use log-rank tests for time-to-event outcomes.

Recurrence free survival rateAt 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 recurrenceUp to 5 years after resection

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 States
Jordan Winter, MD
Contact
216-844-5777
jordan.winter@UHhospitals.org
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