Pancreatic CarcinomaWARPNCT02517268
Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer
A study testing Pancreaticoduodenectomy in people with Pancreatic Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2015to 28 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreaticoduodenectomy
- Firm gland texture
- Subjects able to provide informed consent
Who cannot join
- Preoperative factors:
- Congestive heart failure (CHF)
- End stage renal disease (ESRD)
- Chronic obstructive pulmonary disease (COPD)
- Pregnancy
- Albumin < 3 gm/dL
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Pancreatic Carcinoma
- Being tested
- Pancreaticoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaticoduodenectomyProcedure or surgery
Also called Pancreatoduodenectomy, Whipple procedure, Kausch-Whipple procedure
| Study group | Role | What they receive |
|---|---|---|
| Standard 7-Day Pathway | Active comparator | Patients follow the standard 7-day pathway following pancreaticoduodenectomy Receives: Procedure: Pancreaticoduodenectomy |
| Accelerated 5-Day Pathway | Experimental | 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. Receives: Procedure: Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to post-operative day 5
Secondary outcomes (4)
Post-operative Median Length of Stay
Measured: 30 days after operation
Cost
Cost will be assessed by reviewing inpatient hospital charges
Measured: 30 days after operation
Readmission Rate
Measured: 30 days after operation
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.)
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study start24 Jun 2015
- Primary completion28 Jan 2018
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harish Lavu, MD, Study chair, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517268
- Sponsor's protocol ID
- 15D.050
- Other IDs
- 2014-082, JT 6901
- Acronym
- WARP
- Status last verified
- Apr 2025
- First submitted
- 30 Jul 2015
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30660818
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Evaluating an Accelerated 5 Day Pathway for Discharge Following Pancreaticoduodenectomy (PD): Whipple Accelerated Recovery Pathway (WARP Trial)
- ClinicalTrials.gov ID
- NCT02517268
- Acronym / sponsor ID
- WARP / 15D.050
- Conditions
- Pancreatic Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 24 Jun 2015 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Posted 19 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard 7-Day Pathway | Active comparator | Procedure: PancreaticoduodenectomyPatients follow the standard 7-day pathway following pancreaticoduodenectomy |
| Accelerated 5-Day Pathway | Experimental | Procedure: PancreaticoduodenectomyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pancreaticoduodenectomy
- Firm gland texture
- Subjects able to provide informed consent
Key exclusion criteria (13 listed)
- Preoperative factors:
- Intraoperative factors:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PancreaticoduodenectomyAlso: Pancreatoduodenectomy, Whipple procedure, Kausch-Whipple procedure | Procedure or surgery | Accelerated 5-Day Pathway, Standard 7-Day Pathway |
Primary outcome
Percentage 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 percentage of patients discharged on post-operative day 5
4 secondary outcomes
Post-operative Median Length of Stay
Time frame: 30 days after operation
Cost
Time frame: 30 days after operation
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30660818Lavu 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.
- Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Jefferson University HospitalsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harish Lavu, MD study chair
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreaticoduodenectomy in people with Pancreatic Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Discharged by Post-operative Day 5 (time frame: Up to post-operative day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02517268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.