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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-082 | Other Identifier | CCRRC | |
| JT 6901 | Other Identifier | JeffTrial Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard 7-Day Pathway | Active Comparator | Patients follow the standard 7-day pathway following 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreaticoduodenectomy | Procedure |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Preoperative factors:
Intraoperative factors:
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| Name | Affiliation | Role |
|---|---|---|
| Harish Lavu, MD | Thomas Jefferson University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30660818 | Derived | 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. |
| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center | View source |
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard 7-Day Pathway | Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy |
| FG001 | 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. Pancreaticoduodenectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard 7-Day Pathway | Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy |
| BG001 | 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. Pancreaticoduodenectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Up to post-operative day 5 |
|
baseline to 3 months after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard 7-Day Pathway | Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Gastric Emptying | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic Fistula | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harish Lavu | Sidney Kimmel Cancer Center at Thomas Jefferson University | 215-955-6888 | Harish.Lavu@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2017 | Nov 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| Jefferson University Hospitals | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Secondary | Post-operative Median Length of Stay | Posted | Median | Full Range | days | 30 days after operation |
|
|
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| Secondary | Cost | Cost will be assessed by reviewing inpatient hospital charges | Posted | Median | Full Range | US Dollar | 30 days after operation |
|
|
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| Secondary | Readmission Rate | Posted | Count of Participants | Participants | 30 days after operation |
|
|
|
| Secondary | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Posted | Count of Participants | Participants | 30 days after operation |
|
|
|
| 10 |
| 39 |
| 0 |
| 39 |
| 17 |
| 39 |
| EG001 | 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. Pancreaticoduodenectomy | 13 | 37 | 1 | 37 | 5 | 37 |
| Delayed Gastric Emptying | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| intra-abdominal abscess |
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| Wound Infection |
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| Urinary Tract Infection (UTI) |
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| Pancreatic Fistula |
|
| Renal Failure |
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| Cardiovascular |
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| Pulmonary |
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| Deep Vein Thrombosis |
|