Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy
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About
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.
Full description
This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy. Adult patients with symptomatic benign, premalignant, or resectable malignant pathologies recommended for resection after multidisciplinary review and have already chosen to have robotic surgery will be evaluated for enrolling into the study.
Relevant operative, postoperative, and pathologic outcomes will be collected prospectively. The well-established enhanced recovery after pancreaticoduodenectomy pathway currently used in our institution will be applied to all patients postoperatively.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- ≥18 years old
- Symptomatic benign, premalignant, or resectable malignant periampullary and pancreatic tumor requiring resection
- Fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams
- Able to consent to participate in the study
- Appropriate for robotic approach as determined by participating surgeons
Exclusion criteria
- Arterial (superior mesenteric artery, celiac axis, hepatic artery) or venous involvement (superior mesenteric vein, portal vein) which meets the definition of borderline or unresectable tumor
- Pregnancy
- BMI >40 kg/m2
- Patient requires an additional surgical resection during the index operation (such as hepatectomy or colectomy)
Trial design
Primary purpose
Allocation
Interventional model
Masking
91 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Jin He, MD,PhD
Data sourced from clinicaltrials.gov
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