Clinical trial NCT04171440: Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy
Official title: Perioperative Outcomes of Robotic Approach for Pancreaticoduodenectomy: a Multi-center, Prospective, Single Arm, Observational Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreaticoduodenectomy
Keywords: minimally invasive, robotic, surgery
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Length of hospital stay
timeFrame: up to 90 days post intervention
Secondary outcomes:
measure: Time to functional recovery
timeFrame: Day 1 post-intervention to functional recovery
measure: Number of participants experiencing complications
timeFrame: Day 90 post-intervention
measure: Operative estimated blood loss
timeFrame: During the surgery
measure: Number of participants experiencing pancreaticoduodenectomy-specific complications
timeFrame: Day 90 post-intervention
measure: Pathological outcomes as assessed by Pathological response to neoadjuvant therapy
timeFrame: Day 90-post intervention
measure: Survival Outcome
timeFrame: Overall survival is from surgery to last time of follow-up or death, assessed up to 60 months-post intervention.
measure: Quality of life (QoL) as measured by EQ-5D-3L
timeFrame: EQ-5D-3L will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
measure: Quality of life (QoL) as measured by QLQ-C30 (version 3)
timeFrame: QLQ-C30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
measure: Exploratory outcomes
timeFrame: 30 days after the surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
affiliation: Johns Hopkins University
name: Jin He, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.