Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer (WARP)
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|ClinicalTrials.gov Identifier: NCT02517268|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2015
Last Update Posted : December 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Carcinoma||Procedure: Pancreaticoduodenectomy||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)|
|Actual Study Start Date :||June 24, 2015|
|Estimated Primary Completion Date :||August 7, 2019|
|Estimated Study Completion Date :||August 2020|
Active Comparator: Standard 7-Day Pathway
Patients follow the standard 7-day pathway following pancreaticoduodenectomy
Experimental: Accelerated 5-Day Pathway
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.
- Proportion of patients discharged by post-operative day 5 [ Time Frame: Up to post-operative day 5 ]Two-sided alpha 0.05 will be used to detect a increase in the proportion of patients discharged on post-operative day 5
- Post-operative median length of stay [ Time Frame: 30 days after operation ]
- Cost [ Time Frame: 30 days after operation ]Cost will be assessed by reviewing inpatient hospital charges
- Readmission rate [ Time Frame: 30 days after operation ]
- Incidence of post-operative complications (DGE, anastomotic leaks, intra-abdominal abscesses, wound infection, UTI, respiratory compromise, renal failure, etc.) [ Time Frame: 30 days after operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517268
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Chair:||Harish Lavu, MD||Thomas Jefferson University|