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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 : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

Condition or disease Intervention/treatment Phase
Acinar Cell Carcinoma Ampulla of Vater Adenocarcinoma Cholangiocarcinoma Duodenal Adenocarcinoma Pancreatic Adenocarcinoma Pancreatic Ductal Adenocarcinoma Pancreatic Intraductal Papillary Mucinous Neoplasm, Pancreatobiliary-Type Periampullary Adenocarcinoma Procedure: Pancreatectomy Other: Lavage Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 667 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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 : April 27, 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : January 2021


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Disease Free survival [ Time Frame: Up to 5 years after resection ]
    Will use log-rank tests for time-to-event outcomes.

  3. Recurrence free survival rate [ Time Frame: At 1 year after resection ]
  4. Site of first recurrence [ Time Frame: Up to 5 years after resection ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757859


Contacts
Contact: Jordan Winter, MD 215-955-8874

Locations
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jordan Winter, MD    215-955-8874      
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Principal Investigator: Jordan Winter, MD Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02757859     History of Changes
Other Study ID Numbers: 16D.083
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancrelipase
Pancreatin
Gastrointestinal Agents