Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy

NCT04171440 | Completed DMC

• 2 other identifiers: J19102IRB00219628
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pancreaticoduodenectomy

Keywords

minimally invasive, robotic, surgery

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Days from date of intervention to discharge

  up to 90 days post intervention

Secondary Outcomes (9)

• Time to functional recovery

  Day 1 post-intervention to functional recovery

• Number of participants experiencing complications

  Day 90 post-intervention

• Operative estimated blood loss

  During the surgery

• Number of participants experiencing pancreaticoduodenectomy-specific complications

  Day 90 post-intervention

• Pathological outcomes as assessed by Pathological response to neoadjuvant therapy

  Day 90-post intervention

Study Arms (1)

Minimally Invasive Pancreaticoduodenectomy

EXPERIMENTAL

Patients that undergo pancreaticoduodenectomy through small incisions with state-of-the-art robotic-assisted technology.

Procedure: robotic pancreaticoduodenectomy

Interventions

robotic pancreaticoduodenectomy PROCEDURE

The robotic pancreaticoduodenectomy is performed through small incisions using robotic-assisted technology. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater.

Minimally Invasive Pancreaticoduodenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Related Publications (1)

• 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.

  PMID: 23728278 BACKGROUND

Study Officials

• Jin He, MD,PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: February 18, 2020
• Primary Completion: December 31, 2024
• Study Completion: October 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)