Trial Outcomes & Findings for Accelerated Recovery Pathway for Discharge After Surgery in Patients With Pancreatic Cancer (NCT NCT02517268)

NCT ID: NCT02517268

Last Updated: 2025-04-30

Results Overview

Two-sided alpha 0.05 will be used to detect a increase in the percentage of patients discharged on post-operative day 5

Recruitment status

COMPLETED

Study phase

Target enrollment

98 participants

Primary outcome timeframe

Up to post-operative day 5

Results posted on

2025-04-30

Participant Flow

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

Participant milestones

Participant milestones
Measure	Standard 7-Day Pathway Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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
Overall Study STARTED	40	37
Overall Study COMPLETED	39	37
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard 7-Day Pathway Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	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
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard 7-Day Pathway n=39 Participants Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	Accelerated 5-Day Pathway n=37 Participants 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	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	36 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	37 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Standard 7-Day Pathway n=39 Participants Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	Accelerated 5-Day Pathway n=37 Participants 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
Percentage of Patients Discharged by Post-operative Day 5	5 Participants	28 Participants

SECONDARY outcome

Timeframe: 30 days after operation

Outcome measures

Outcome measures
Measure	Standard 7-Day Pathway n=39 Participants Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	Accelerated 5-Day Pathway n=37 Participants 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
Post-operative Median Length of Stay	6 days Interval 5.0 to 23.0	5 days Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: 30 days after operation

Cost will be assessed by reviewing inpatient hospital charges

Outcome measures

Outcome measures
Measure	Standard 7-Day Pathway n=39 Participants Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	Accelerated 5-Day Pathway n=37 Participants 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
Cost	155,542 US Dollar	139,735 US Dollar

SECONDARY outcome

Timeframe: 30 days after operation

Outcome measures

Outcome measures
Measure	Standard 7-Day Pathway n=39 Participants Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	Accelerated 5-Day Pathway n=37 Participants 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
Readmission Rate	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days after operation

Outcome measures

Outcome measures
Measure	Standard 7-Day Pathway n=39 Participants Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	Accelerated 5-Day Pathway n=37 Participants 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
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	5 Participants
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) Anastomotic leaks	0 Participants	0 Participants
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) intra-abdominal abscess	1 Participants	1 Participants
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) Wound Infection	1 Participants	0 Participants
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	1 Participants
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) Pancreatic Fistula	2 Participants	4 Participants
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) Renal Failure	0 Participants	0 Participants
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) Cardiovascular	0 Participants	1 Participants
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) Pulmonary	3 Participants	0 Participants
Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.) Deep Vein Thrombosis	0 Participants	0 Participants

Adverse Events

Standard 7-Day Pathway

Serious events: 0 serious events

Other events: 17 other events

Deaths: 10 deaths

Accelerated 5-Day Pathway

Serious events: 1 serious events

Other events: 5 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Standard 7-Day Pathway n=39 participants at risk Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	Accelerated 5-Day Pathway n=37 participants at risk 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
Gastrointestinal disorders Delayed Gastric Emptying	0.00% 0/39 • baseline to 3 months after surgery	2.7% 1/37 • Number of events 1 • baseline to 3 months after surgery

Other adverse events

Other adverse events
Measure	Standard 7-Day Pathway n=39 participants at risk Patients follow the standard 7-day pathway following pancreaticoduodenectomy Pancreaticoduodenectomy	Accelerated 5-Day Pathway n=37 participants at risk 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
Gastrointestinal disorders Pancreatic Fistula	7.7% 3/39 • baseline to 3 months after surgery	2.7% 1/37 • baseline to 3 months after surgery
Gastrointestinal disorders Delayed Gastric Emptying	23.1% 9/39 • baseline to 3 months after surgery	8.1% 3/37 • baseline to 3 months after surgery
Respiratory, thoracic and mediastinal disorders Pulmonary	7.7% 3/39 • baseline to 3 months after surgery	0.00% 0/37 • baseline to 3 months after surgery
Infections and infestations Urinary Tract Infection	5.1% 2/39 • baseline to 3 months after surgery	2.7% 1/37 • baseline to 3 months after surgery

Additional Information

Dr. Harish Lavu

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-6888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place