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
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
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: ProcedureMinimally Invasive Pancreaticoduodenectomy
Procedure
Experimental Group · 1 Intervention: robotic pancreaticoduodenectomy · Intervention Types: ProcedureCohort B-open pancreaticoduodenectomy
Procedure
ActiveComparator Group · 1 Intervention: open pancreaticoduodenectomy · Intervention Types: ProcedureTreatment
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.
References
- Slankamenac, Ksenija, Rolf Graf, Jeffrey Barkun, Milo A. Puhan, and Pierre-Alain Clavien. 2013. “The Comprehensive Complication Index”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e318296c732.
- 2020. "Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04171440.
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Conditions
Cancer Related
Treatments