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

Pancreatic Carcinoma Clinical Trial

— WARP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517268
• Other study ID #: 15D.050
• Secondary ID: 2014-082
• Status: Completed
• Phase: N/A
• Start date: June 24, 2015
• Est. completion date: March 28, 2019

Study information

• Verified date: December 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 28, 2019
• Est. primary completion date: January 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Procedure:
• Pancreaticoduodenectomy

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Discharged by 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	Post-operative Median Length of Stay		30 days after operation
Secondary	Cost	Cost will be assessed by reviewing inpatient hospital charges	30 days after operation
Secondary	Readmission Rate		30 days after operation
Secondary	Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.)		30 days after operation

External Links

•   Jefferson University Hospitals
•   Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center