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

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02517268
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Arms: 2
• Actual Duration (Months): 45.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Carcinoma	Procedure: Pancreaticoduodenectomy	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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:

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• 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: Jun 24, 2015
• Actual Primary Completion Date: Jan 28, 2018
• Actual Study Completion Date: Mar 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard 7-Day Pathway Patients follow the standard 7-day pathway following pancreaticoduodenectomy	Procedure: Pancreaticoduodenectomy; Other Names: Pancreatoduodenectomy Whipple procedure Kausch-Whipple procedure
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.	Procedure: Pancreaticoduodenectomy; Other Names: Pancreatoduodenectomy Whipple procedure Kausch-Whipple procedure

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Discharged by Post-operative Day 5 [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

Secondary Outcome Measures

1. Post-operative Median Length of Stay [30 days after operation]

2. Cost [30 days after operation]

   Cost will be assessed by reviewing inpatient hospital charges

3. Readmission Rate [30 days after operation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

• Study Chair: Harish Lavu, MD, Thomas Jefferson University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 24, 2017

More Information

Additional Information:

• Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Jefferson University Hospitals

Publications

None provided.

• Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT02517268
• Other Study ID Numbers: 15D.050; 2014-082
• First Posted: Aug 6, 2015
• Last Update Posted: Dec 19, 2019
• Last Verified: Dec 1, 2019

• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

Participant Flow

Recruitment Details	22 participants were not included in the final analysis as they were not randomized to either arm of the study. Prior to randomization, 3 participants withdrew consent, and 19 participants did not undergo their procedure at Thomas Jefferson University Hospital
Pre-assignment Detail	22 participants were not included in the final analysis as they were not randomized to either arm of the study. Prior to randomization, 3 participants withdrew consent, and 19 participants did not undergo their procedure at Thomas Jefferson University Hospital. On the control arm, 1 participant withdrew consent after randomization

Arm/Group Title	Standard 7-Day Pathway	Accelerated 5-Day Pathway
Arm/Group Description	Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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. Pancreaticoduodenectomy
Period Title: Overall Study
STARTED	40	37
COMPLETED	39	37
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Standard 7-Day Pathway	Accelerated 5-Day Pathway	Total
Arm/Group Description	Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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. Pancreaticoduodenectomy	Total of all reporting groups
Overall Participants	39	37	76
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 46.2%	15 40.5%	33 43.4%
>=65 years	21 53.8%	22 59.5%	43 56.6%
Sex: Female, Male (Count of Participants)
Female	22 56.4%	17 45.9%	39 51.3%
Male	17 43.6%	20 54.1%	37 48.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.1%	1 2.7%	3 3.9%
Not Hispanic or Latino	36 92.3%	35 94.6%	71 93.4%
Unknown or Not Reported	1 2.6%	1 2.7%	2 2.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 5.1%	1 2.7%	3 3.9%
White	34 87.2%	36 97.3%	70 92.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 7.7%	0 0%	3 3.9%
Region of Enrollment (participants) [Number]
United States	39 100%	37 100%	76 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Discharged by Post-operative Day 5
Description	Two-sided alpha 0.05 will be used to detect a increase in the percentage of patients discharged on post-operative day 5
Time Frame	Up to post-operative day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard 7-Day Pathway	Accelerated 5-Day Pathway
Arm/Group Description	Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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. Pancreaticoduodenectomy
Measure Participants	39	37
Count of Participants [Participants]	5 12.8%	28 75.7%

2. Secondary Outcome

Title	Post-operative Median Length of Stay
Time Frame	30 days after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard 7-Day Pathway	Accelerated 5-Day Pathway
Arm/Group Description	Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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. Pancreaticoduodenectomy
Measure Participants	39	37
Median (Full Range) [days]	6	5

3. Secondary Outcome

Title	Cost
Description	Cost will be assessed by reviewing inpatient hospital charges
Time Frame	30 days after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard 7-Day Pathway	Accelerated 5-Day Pathway
Arm/Group Description	Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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. Pancreaticoduodenectomy
Measure Participants	39	37
Median (Full Range) [US Dollar]	155,542	139,735

4. Secondary Outcome

Title	Readmission Rate
Time Frame	30 days after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard 7-Day Pathway	Accelerated 5-Day Pathway
Arm/Group Description	Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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. Pancreaticoduodenectomy
Measure Participants	39	37
Count of Participants [Participants]	4 10.3%	3 8.1%

5. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard 7-Day Pathway	Accelerated 5-Day Pathway
Arm/Group Description	Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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. Pancreaticoduodenectomy
Measure Participants	39	37
Delayed Gastric Emptying (DGE)	13 33.3%	5 13.5%
Anastomotic leaks	0 0%	0 0%
intra-abdominal abscess	1 2.6%	1 2.7%
Wound Infection	1 2.6%	0 0%
Urinary Tract Infection (UTI)	2 5.1%	1 2.7%
Pancreatic Fistula	2 5.1%	4 10.8%
Renal Failure	0 0%	0 0%
Cardiovascular	0 0%	1 2.7%
Pulmonary	3 7.7%	0 0%
Deep Vein Thrombosis	0 0%	0 0%

Adverse Events

Time Frame	baseline to 3 months after surgery
Arm/Group Title	Standard 7-Day Pathway		Accelerated 5-Day Pathway
Arm/Group Description	Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy		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. Pancreaticoduodenectomy
All Cause Mortality
	Standard 7-Day Pathway		Accelerated 5-Day Pathway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/39 (25.6%)		13/37 (35.1%)
Serious Adverse Events
	Standard 7-Day Pathway		Accelerated 5-Day Pathway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		1/37 (2.7%)
Gastrointestinal disorders
Delayed Gastric Emptying	0/39 (0%)	0	1/37 (2.7%)	1
Other (Not Including Serious) Adverse Events
	Standard 7-Day Pathway		Accelerated 5-Day Pathway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/39 (43.6%)		5/37 (13.5%)
Gastrointestinal disorders
Pancreatic Fistula	3/39 (7.7%)		1/37 (2.7%)
Delayed Gastric Emptying	9/39 (23.1%)		3/37 (8.1%)
Infections and infestations
Urinary Tract Infection	2/39 (5.1%)		1/37 (2.7%)
Respiratory, thoracic and mediastinal disorders
Pulmonary	3/39 (7.7%)		0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.