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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/26/2018
Start Date:June 24, 2015
End Date:August 2020

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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.

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.

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
We found this trial at
1
site
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Harish Lavu, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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from
Philadelphia, PA
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