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Clinical Trial Record

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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

2016-04-27

2026-04-27

2026-04-27

845

Study Overview

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

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.

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.

  • Acinar Cell Carcinoma
  • Ampulla of Vater Adenocarcinoma
  • Cholangiocarcinoma
  • Duodenal Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Intraductal Papillary Mucinous Neoplasm
  • Periampullary Adenocarcinoma
  • PROCEDURE: Pancreatectomy
  • OTHER: Lavage
  • PROCEDURE: Pancreatectomy
  • OTHER: Lavage
  • PROCEDURE: Pancreatectomy
  • 16D.083
  • JT 6902 (OTHER Identifier) (OTHER: JeffTrial Number)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2016-04-29  

N/A  

2025-05-15  

2016-04-29  

N/A  

2025-05-20  

2016-05-02  

N/A  

2025-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Arm I (EIPL-S)

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-S lavage 10 times over 15 minutes.

PROCEDURE: Pancreatectomy

  • Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

OTHER: Lavage

  • Receive EIPL-S
ACTIVE_COMPARATOR: Arm II (EIPL-D)

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-D lavage 10 times over 15 minutes.

PROCEDURE: Pancreatectomy

  • Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

OTHER: Lavage

  • Receive EIPL-D
SHAM_COMPARATOR: ARM III (NO LAVAGE)

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.

PROCEDURE: Pancreatectomy

  • Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Primary Outcome MeasuresMeasure DescriptionTime Frame
Overall SurvivalWill 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 Outcome MeasuresMeasure DescriptionTime Frame
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
Disease Free survivalWill use log-rank tests for time-to-event outcomes.Up to 5 years after resection
Recurrence free survival rateAt 1 year after resection
Site of first recurrenceUp to 5 years after resection

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Harish Lavu, MD

Phone Number: 215-955-9402

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Harish Lavu, MD, Thomas Jefferson University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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