Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy

NCT ID: NCT04171440

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-18
• Study Completion Date: 2025-10-01

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.

Conditions

Pancreaticoduodenectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minimally Invasive Pancreaticoduodenectomy

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

Group Type: EXPERIMENTAL

robotic pancreaticoduodenectomy

Intervention Type: 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.

Interventions

robotic pancreaticoduodenectomy

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin He, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Atrium Health

Charlotte, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23728278 (View on PubMed)

Other Identifiers

IRB00219628

Identifier Type: OTHER

Identifier Source: secondary_id

J19102

Identifier Type: -

Identifier Source: org_study_id