NCT02517268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

December 19, 2019

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

July 30, 2015

Results QC Date

November 7, 2019

Last Update Submit

April 28, 2025

Conditions

Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Post-operative Median Length of Stay

    30 days after operation

  • Cost

    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

Study Arms (2)

Standard 7-Day Pathway

ACTIVE COMPARATOR

Patients follow the standard 7-day pathway following pancreaticoduodenectomy

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.

Procedure: Pancreaticoduodenectomy

Interventions

PancreaticoduodenectomyPROCEDURE
Also known as: Pancreatoduodenectomy, Whipple procedure, Kausch-Whipple procedure
Accelerated 5-Day PathwayStandard 7-Day Pathway

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreaticoduodenectomy
  • Firm gland texture
  • Subjects able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 30660818DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Harish Lavu
Organization
Sidney Kimmel Cancer Center at Thomas Jefferson University
Harish.Lavu@jefferson.edu
215-955-6888

Study Officials

  • Harish Lavu, MD

    Thomas Jefferson University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 6, 2015

Study Start

June 24, 2015

Primary Completion

January 28, 2018

Study Completion

March 28, 2019

Last Updated

April 30, 2025

Results First Posted

December 19, 2019

Record last verified: 2025-04

Locations

US(1)