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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

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02757859
Collaborator
(none)
667
Enrollment
2
Locations
3
Arms
80.2
Anticipated Duration (Months)
333.5
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pancreatectomy
  • Other: Lavage
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Overall survival (OS) (18 to 27 months after resection).
SECONDARY OBJECTIVES:
  1. 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) extensive intraoperative peritoneal saline lavage: 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) extensive intraoperative peritoneal distilled water lavage: 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
667 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The WASH (Water or Saline at High Volumes) Trial: A Randomized Trial to Assess the Survival Impact of Extensive Peritoneal Lavage Using Distilled WAter or Saline at High Volumes After Pancreatic Resection for Pancreatic Ductal Adenocarcinoma
Actual Study Start Date :
Apr 27, 2016
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Procedure: Pancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
Other Names:
  • Excision of the Pancreas
  • Pancreas Excision

    • Other: Lavage
    Receive extensive intraoperative peritoneal saline (EIPL-S) lavage
    Other Names:
  • Irrigation

    		•
    Active Comparator: 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

    Procedure: Pancreatectomy
    Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
    Other Names:
  • Excision of the Pancreas
  • Pancreas Excision

    • Other: Lavage
    Receive extensive intraoperative peritoneal saline (EIPL-S) lavage
    Other Names:
  • Irrigation

    		•
    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
    Other Names:
  • Excision of the Pancreas
  • Pancreas Excision

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Disease Free survival [Up to 5 years after resection]

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

    3. Recurrence free survival rate [At 1 year after resection]

    4. Site of first recurrence [Up to 5 years after resection]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • The subject is not willing to consent to EIPL-S lavage vs. EIPL-D lavage vs. standard

    • Subject with neoadjuvant chemotherapy or chemoradiation

    • Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Case Western Reserve University Cleveland Ohio United States 44106
    2 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Investigators

    • Principal Investigator: Harish Lavu, MD, Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT02757859
    Other Study ID Numbers:
    • 16D.083
    First Posted:
    May 2, 2016
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Cholangiocarcinoma
    Carcinoma, Acinar Cell
    Pancreatic Intraductal Neoplasms
    Pancrelipase
    Pancreatin

    Study Results

    No Results Posted as of Nov 4, 2021