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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Brief Title

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

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

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

Interventional

Primary Outcome

Overall Survival

Secondary Outcome

 Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)

Condition

Acinar Cell Carcinoma

Intervention

Pancreatectomy

Study Arms / Comparison Groups

 Arm I (EIPL-S)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

667

Start Date

April 27, 2016

Completion Date

January 2022

Primary Completion Date

August 2021

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Harish Lavu, MD, 215-955-9402,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02757859

Organization ID

16D.083

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Sponsor

Harish Lavu, MD, Principal Investigator, Thomas Jefferson University

Verification Date

October 2020