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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Carcinoma

Intervention / Treatment
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* Procedure: Pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pancreaticoduodenectomy Firm gland texture Subjects able to provide informed consent Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard 7-Day Pathway<br>Patients follow the standard 7-day pathway following pancreaticoduodenectomy | Procedure: Pancreaticoduodenectomy<br> <br> * Other names: Kausch-Whipple procedure;|
| Experimental: Accelerated 5-Day Pathway<br>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. | Procedure: Pancreaticoduodenectomy<br> <br> * Other names: Kausch-Whipple procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Median Length of Stay |  | 30 days after operation | 
| Cost | Cost will be assessed by reviewing inpatient hospital charges | 30 days after operation | 
| Readmission Rate |  | 30 days after operation | 
| Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) |  | 30 days after operation |