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Completed

NCT Number: NCT02517268

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pancreaticoduodenectomy
  • Firm gland texture
  • Subjects able to provide informed consent

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Pancreaticoduodenectomy

Procedure

Other names: Pancreatoduodenectomy, Whipple procedure, Kausch-Whipple procedure

Primary outcomes

  1. 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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Acronym: WARP

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Aug 6, 2015
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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