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

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ClinicalTrials.gov Identifier: NCT02517268
Recruitment Status : Active, not recruiting
First Posted : August 6, 2015
Last Update Posted : December 24, 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 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.

Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Procedure: Pancreaticoduodenectomy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)
Actual Study Start Date : June 24, 2015
Estimated Primary Completion Date : August 7, 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion 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 proportion of patients discharged on post-operative day 5


Secondary Outcome Measures :
  1. Post-operative median length of stay [ Time Frame: 30 days after operation ]
  2. Cost [ Time Frame: 30 days after operation ]
    Cost will be assessed by reviewing inpatient hospital charges

  3. Readmission rate [ Time Frame: 30 days after operation ]
  4. 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 ]


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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:

  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

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): NCT02517268


Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Study Chair: Harish Lavu, MD Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02517268     History of Changes
Other Study ID Numbers: 15D.050
2014-082 ( Other Identifier: CCRRC )
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases