Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer (WARP)

April 28, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)

This randomized clinical trial studies accelerated recovery pathway for discharge after surgery in patients with pancreatic cancer. A standardized accelerated recovery pathway may improve outcomes after surgery following complex abdominal operations resulting in a shorter length of stay in patients with pancreatic cancer. It may also help patients to mobilize more quickly and return to the home setting, decrease hospital-acquired infectious complications, and increase potential cost savings. It is not yet known whether an accelerated recovery pathway is better than a standard recovery pathway for discharge following surgery in patients with pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. The use of an accelerated pathway will result in a shorter postoperative hospital length of stay for patients undergoing pancreaticoduodenectomy (PD) without an increase in perioperative complications or readmission rates.

SECONDARY OBJECTIVES:

I. The investigators anticipate lower cost, lower readmission rate, similar rate of post-operative complications (delayed gastric emptying [DGE], anastomotic leaks, intra-abdominal abscesses, wound infection, urinary tract infection [UTI], respiratory compromise, renal failure, etc.) in our study group.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients follow the standard 7-day pathway at the end of surgery.

ARM II: Patients follow the Whipple accelerated 5-day pathway at the end of surgery. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.

After completion of study treatment, patients are followed up periodically.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pancreaticoduodenectomy
  2. Firm gland texture
  3. Subjects able to provide informed consent

Exclusion Criteria:

  1. Preoperative factors:

    • Congestive heart failure (CHF)
    • End stage renal disease (ESRD)
    • Chronic obstructive pulmonary disease (COPD)
    • Pregnancy
    • Albumin < 3 gm/dL
    • Poor preoperative performance status as defined by: timed get up and go (< 15 seconds)
    • Patients cannot be homeless or have substance dependence

  2. Intraoperative factors:

    • Estimated blood loss (EBL) > 1 liter
    • Failure to extubate at the conclusion of the case
    • Operative time > 8 hours
    • Need for vascular resection/reconstruction

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard 7-Day Pathway
Patients follow the standard 7-day pathway following pancreaticoduodenectomy
Procedure: Pancreaticoduodenectomy
Other Names:
  • Pancreatoduodenectomy
  • Whipple procedure
  • Kausch-Whipple procedure
Experimental: Accelerated 5-Day Pathway
Patients follow the Whipple accelerated 5-day pathway following pancreaticoduodenectomy. The accelerated pathway includes more rapidly leaving the ICU setting, early mobilization and enhanced physical therapy, multimodal pain control, dietary modifications, and increased and standardized phone contact by a nurse practitioner during the first week following hospital discharge.
Procedure: Pancreaticoduodenectomy
Other Names:
  • Pancreatoduodenectomy
  • Whipple procedure
  • Kausch-Whipple procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Discharged by Post-operative Day 5
Time Frame: Up to post-operative day 5
Two-sided alpha 0.05 will be used to detect a increase in the percentage of patients discharged on post-operative day 5
Up to post-operative day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Median Length of Stay
Time Frame: 30 days after operation
30 days after operation
Cost
Time Frame: 30 days after operation
Cost will be assessed by reviewing inpatient hospital charges
30 days after operation
Readmission Rate
Time Frame: 30 days after operation
30 days after operation
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.)
Time Frame: 30 days after operation
30 days after operation

Collaborators and Investigators

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

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Study Chair: Harish Lavu, MD, Thomas Jefferson University

Publications and helpful links

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

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

June 24, 2015

Primary Completion (Actual)

January 28, 2018

Study Completion (Actual)

March 28, 2019

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimated)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15D.050
  • 2014-082 (Other Identifier: CCRRC)
  • JT 6901 (Other Identifier: JeffTrial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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