Clinical Trials Directory

Trials / Completed

CompletedNCT02517268

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPancreaticoduodenectomy

Timeline

Start date
2015-06-24
Primary completion
2018-01-28
Completion
2019-03-28
First posted
2015-08-06
Last updated
2025-04-30
Results posted
2019-12-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02517268. Inclusion in this directory is not an endorsement.