NCT02517268: WARP

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

Completed NA Results posted Last updated 30 April 2025

What this trial tests

NA trial testing Pancreaticoduodenectomy in Pancreatic Carcinoma in 98 participants. Completed in 28 March 2019.

Timeline

24 June 2015

Primary endpoint
28 January 2018

28 March 2019

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	98
Start date	24 June 2015
Primary completion	28 January 2018
Estimated completion	28 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Pancreaticoduodenectomy

Conditions studied

• Pancreatic Carcinoma — all drugs for Pancreatic Carcinoma →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who can join

18 and older, any sex, with Pancreatic Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Discharged by Post-operative Day 5 Primary · 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

Group	Value	95% CI
Standard 7-Day Pathway	5
Accelerated 5-Day Pathway	28

Post-operative Median Length of Stay Secondary · 30 days after operation

Group	Value	95% CI
Standard 7-Day Pathway	6	5 – 23
Accelerated 5-Day Pathway	5	4 – 11

Cost Secondary · 30 days after operation

Cost will be assessed by reviewing inpatient hospital charges

Group	Value	95% CI
Standard 7-Day Pathway	155,542	125,519 – 398,764
Accelerated 5-Day Pathway	139,735	104,689 – 253,830

Readmission Rate Secondary · 30 days after operation

Group	Value	95% CI
Standard 7-Day Pathway	4
Accelerated 5-Day Pathway	3

Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) Secondary · 30 days after operation

Delayed Gastric Emptying (DGE)

Group	Value	95% CI
Standard 7-Day Pathway	13
Accelerated 5-Day Pathway	5

Anastomotic leaks

Group	Value	95% CI
Standard 7-Day Pathway	0
Accelerated 5-Day Pathway	0

intra-abdominal abscess

Group	Value	95% CI
Standard 7-Day Pathway	1
Accelerated 5-Day Pathway	1

Wound Infection

Group	Value	95% CI
Standard 7-Day Pathway	1
Accelerated 5-Day Pathway	0

Urinary Tract Infection (UTI)

Group	Value	95% CI
Standard 7-Day Pathway	2
Accelerated 5-Day Pathway	1

Pancreatic Fistula

Group	Value	95% CI
Standard 7-Day Pathway	2
Accelerated 5-Day Pathway	4

Renal Failure

Group	Value	95% CI
Standard 7-Day Pathway	0
Accelerated 5-Day Pathway	0

Cardiovascular

Group	Value	95% CI
Standard 7-Day Pathway	0
Accelerated 5-Day Pathway	1

Adverse events — posted to ClinicalTrials.gov

Time frame: baseline to 3 months after surgery. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard 7-Day Pathway

Serious: 0/39 (0%)

Deaths: 10/39

Accelerated 5-Day Pathway

Serious: 1/37 (3%)

Deaths: 13/37

Serious adverse events (1 terms)

Reaction	System	Standard 7-Day Pathway	Accelerated 5-Day Pathway
Delayed Gastric Emptying	Gastrointestinal disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Standard 7-Day Pathway	Accelerated 5-Day Pathway
Delayed Gastric Emptying	Gastrointestinal disorders	—	—
Pancreatic Fistula	Gastrointestinal disorders	—	—
Pulmonary	Respiratory, thoracic and mediastinal disorders	—	—
Urinary Tract Infection	Infections and infestations	—	—

Most-reported serious reactions: Delayed Gastric Emptying.

Data from ClinicalTrials.gov NCT02517268 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enhancing Patient Outcomes while Containing Costs after Complex Abdominal Operation: A Randomized Controlled Trial of the Whipple Accelerated Recovery Pathway.
   Lavu H, McCall NS, Winter JM, Burkhart RA, et al · · 2019 · cited 41× · PMID 30660818 · DOI 10.1016/j.jamcollsurg.2018.12.032
2. Unlocking the Potential of Bioactive Compounds in Pancreatic Cancer Therapy: A Promising Frontier.
   Brugiapaglia S, Spagnolo F, Curcio C. · · 2025 · cited 1× · PMID 40427617 · DOI 10.3390/biom15050725