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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

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ClinicalTrials.gov Identifier: NCT02757859
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Tracking Information
First Submitted Date  ICMJE April 29, 2016
First Posted Date  ICMJE May 2, 2016
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE April 27, 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2016)
Overall Survival [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02757859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2016)
  • Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0) [ Time Frame: 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 [ Time Frame: Up to 5 years after resection ]
    Will use log-rank tests for time-to-event outcomes.
  • Recurrence free survival rate [ Time Frame: At 1 year after resection ]
  • Site of first recurrence [ Time Frame: Up to 5 years after resection ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery
Official Title  ICMJE 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
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) 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Acinar Cell Carcinoma
  • Ampulla of Vater Adenocarcinoma
  • Cholangiocarcinoma
  • Duodenal Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type
  • Periampullary Adenocarcinoma
Intervention  ICMJE
  • 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 Name: Irrigation
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Pancreatectomy
    • Other: Lavage
  • 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
    Interventions:
    • Procedure: Pancreatectomy
    • Other: Lavage
  • Sham Comparator: ARM III (NO LAVAGE)
    Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.
    Intervention: Procedure: Pancreatectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2016)
667
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Harish Lavu, MD 215-955-9402
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02757859
Other Study ID Numbers  ICMJE 16D.083
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harish Lavu, MD Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP