Pancreatic Carcinoma
Conditions
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.
Interventions
PROCEDUREPancreaticoduodenectomy
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Discharged by Post-operative Day 5 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Median Length of Stay | 30 days after operation | — |
| Cost | 30 days after operation | Cost will be assessed by reviewing inpatient hospital charges |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Standard 7-Day Pathway Patients follow the standard 7-day pathway following pancreaticoduodenectomy
Pancreaticoduodenectomy | 39 |
| 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 | 37 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Standard 7-Day Pathway | Accelerated 5-Day Pathway |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 43 Participants | 21 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 18 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants | 36 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 70 Participants | 34 Participants | 36 Participants |
| Region of Enrollment United States | 76 participants | 39 participants | 37 participants |
| Sex: Female, Male Female | 39 Participants | 22 Participants | 17 Participants |
| Sex: Female, Male Male | 37 Participants | 17 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 39 | 13 / 37 |
| other Total, other adverse events | 17 / 39 | 5 / 37 |
| serious Total, serious adverse events | 0 / 39 | 1 / 37 |
Outcome results
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
Time frame: Up to post-operative day 5
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard 7-Day Pathway | Percentage of Patients Discharged by Post-operative Day 5 | 5 Participants |
| Accelerated 5-Day Pathway | Percentage of Patients Discharged by Post-operative Day 5 | 28 Participants |
Secondary
Cost
Cost will be assessed by reviewing inpatient hospital charges
Time frame: 30 days after operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard 7-Day Pathway | Cost | 155,542 US Dollar |
| Accelerated 5-Day Pathway | Cost | 139,735 US Dollar |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | intra-abdominal abscess | 1 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Deep Vein Thrombosis | 0 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Wound Infection | 1 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Delayed Gastric Emptying (DGE) | 13 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Urinary Tract Infection (UTI) | 2 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Pulmonary | 3 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Pancreatic Fistula | 2 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Anastomotic leaks | 0 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Renal Failure | 0 Participants |
| Standard 7-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Cardiovascular | 0 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Deep Vein Thrombosis | 0 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Cardiovascular | 1 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Pulmonary | 0 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Delayed Gastric Emptying (DGE) | 5 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Anastomotic leaks | 0 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | intra-abdominal abscess | 1 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Wound Infection | 0 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Urinary Tract Infection (UTI) | 1 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Pancreatic Fistula | 4 Participants |
| Accelerated 5-Day Pathway | Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) | Renal Failure | 0 Participants |
Secondary
Post-operative Median Length of Stay
Time frame: 30 days after operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard 7-Day Pathway | Post-operative Median Length of Stay | 6 days |
| Accelerated 5-Day Pathway | Post-operative Median Length of Stay | 5 days |
Secondary
Readmission Rate
Time frame: 30 days after operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard 7-Day Pathway | Readmission Rate | 4 Participants |
| Accelerated 5-Day Pathway | Readmission Rate | 3 Participants |