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2015-06-24
2018-01-28
2019-03-28
98
NCT02517268
Thomas Jefferson University
Thomas Jefferson University
INTERVENTIONAL
Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-07-30 | 2019-11-07 | 2025-04-28 |
2015-08-04 | 2019-12-04 | 2025-04-30 |
2015-08-06 | 2019-12-19 | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Standard 7-Day Pathway Patients follow the standard 7-day pathway following pancreaticoduodenectomy | PROCEDURE: Pancreaticoduodenectomy |
| 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 modification | PROCEDURE: Pancreaticoduodenectomy |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Post-operative Median Length of Stay | 30 days after operation | |
| Cost | Cost will be assessed by reviewing inpatient hospital charges | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
