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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Completed

Conditions: Pancreatic Carcinoma

Treatments: Procedure: Pancreaticoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02517268

15D.050

JT 6901 (Other Identifier)

2014-082 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Standard 7-Day Pathway

Active Comparator group

Description:

Patients follow the standard 7-day pathway following pancreaticoduodenectomy

Treatment:

Procedure: Pancreaticoduodenectomy

Accelerated 5-Day Pathway

Experimental group

Description:

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.

Treatment:

Procedure: Pancreaticoduodenectomy