Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-03-03 @ 2:41 PM
Study NCT ID:
NCT02517268
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2015-07-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Study Overview
Official Title:
A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WARP
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: