minimally invasive pancreaticoduodenectomy for Pancreaticoduodenectomy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreaticoduodenectomyminimally invasive pancreaticoduodenectomy - Procedure
Eligibility
18+
All Sexes
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Study Summary

This trial will study the outcomes of people who have had a robotic pancreaticoduodenectomy, which is a surgery to remove the pancreas and part of the small intestine.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: QLQ-C30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.

Day 30
Exploratory outcomes
Day 1
Time to functional recovery
Day 90 post-intervention
Number of participants experiencing complications
Number of participants experiencing pancreaticoduodenectomy-specific complications
Day 90-post intervention
Neoadjuvant Therapy
During the surgery
Operative estimated blood loss
Month 6
Quality of life (QoL) as measured by EQ-5D-3L
Month 60
Survival Outcome
Month 6
Quality of life (QoL) as measured by QLQ-C30 (version 3)
Day 90
Length of hospital stay

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Cohort B-open pancreaticoduodenectomy
1 of 3
Cohort A-minimally invasive pancreaticoduodenectomy
1 of 3
Minimally Invasive Pancreaticoduodenectomy
1 of 3

Active Control

Experimental Treatment

81 Total Participants · 3 Treatment Groups

Primary Treatment: minimally invasive pancreaticoduodenectomy · No Placebo Group · N/A

Cohort A-minimally invasive pancreaticoduodenectomy
Procedure
Experimental Group · 1 Intervention: minimally invasive pancreaticoduodenectomy · Intervention Types: Procedure
Minimally Invasive Pancreaticoduodenectomy
Procedure
Experimental Group · 1 Intervention: robotic pancreaticoduodenectomy · Intervention Types: Procedure
Cohort B-open pancreaticoduodenectomy
Procedure
ActiveComparator Group · 1 Intervention: open pancreaticoduodenectomy · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
minimally invasive pancreaticoduodenectomy
2016
N/A
~60

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: qlq-c30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
536 Previous Clinical Trials
31,184 Total Patients Enrolled
Jin He, MD,PhDPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a minimum age of 18 years old.
You have a periampullary or pancreatic tumor that requires resection.
You are able to give informed consent.
Appropriate for robotic approach as determined by participating surgeons.
You are fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams.