Clinical trial NCT02517268: Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer
Official title: A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Pancreaticoduodenectomy
2. Firm gland texture
3. Subjects able to provide informed consent

Exclusion Criteria:

1. 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
2. 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

Primary outcomes:
measure: Percentage of Patients Discharged by Post-operative Day 5
timeFrame: Up to post-operative day 5
Secondary outcomes:
measure: Post-operative Median Length of Stay
timeFrame: 30 days after operation
measure: Cost
timeFrame: 30 days after operation
measure: Readmission Rate
timeFrame: 30 days after operation
measure: Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.)
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Harish Lavu, MD
role: STUDY_CHAIR
References:
citation: Lavu H, McCall NS, Winter JM, Burkhart RA, Pucci M, Leiby BE, Yeo TP, Cannaday S, Yeo CJ. Enhancing Patient Outcomes while Containing Costs after Complex Abdominal Operation: A Randomized Controlled Trial of the Whipple Accelerated Recovery Pathway. J Am Coll Surg. 2019 Apr;228(4):415-424. doi: 10.1016/j.jamcollsurg.2018.12.032. Epub 2019 Jan 17.