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

NCT ID: NCT02517268

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-24
• Study Completion Date: 2019-03-28

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.

Conditions

Pancreatic Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard 7-Day Pathway

Patients follow the standard 7-day pathway following pancreaticoduodenectomy

Group Type: ACTIVE_COMPARATOR

Pancreaticoduodenectomy

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

Pancreaticoduodenectomy

Intervention Type: PROCEDURE

Interventions

Pancreaticoduodenectomy

Intervention Type: PROCEDURE

Other Intervention Names

Pancreatoduodenectomy; Whipple procedure; Kausch-Whipple procedure

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harish Lavu, MD

Role: STUDY_CHAIR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30660818 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.KimmelCancerCenter.org

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

http://hospitals.jefferson.edu/

Jefferson University Hospitals

Other Identifiers

2014-082

Identifier Type: OTHER

Identifier Source: secondary_id

JT 6901

Identifier Type: OTHER

Identifier Source: secondary_id

15D.050

Identifier Type: -

Identifier Source: org_study_id