RecruitingNot ApplicableNCT05660915

A Prospective Clinical Study Using an Artery-first Intermediate Approach in Robot-assisted Pancreaticoduodenectomy

A Prospective Clinical Study of the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy Using an Artery-first Intermediate Approach


Sponsor

The First Affiliated Hospital of University of South China

Enrollment

80 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Pancreaticoduodenectomy, as a standard surgical procedure for malignant tumors of the head of the pancreas, ampulla and distal common bile duct, has brought the hope of clinical cure for these diseases.In the whole surgical process, the resection of the uncinate process of the pancreas is considered to be a major difficulty in the whole operation, which can affect the rehabilitation process and long-term prognosis. Two main methods have been developed around the dissection of the uncinate process of the pancreas. One is the Venous-first approach based on the portal vein-superior mesenteric vein axis. The other is the Artery-first approach that first explores whether the superior mesenteric artery is invaded by the tumor to judge resectable. The latter is gradually promoted in clinical practice because it can reduce intraoperative bleeding, reduce postoperative complications, and improve long-term prognosis. The intermediate approach is a surgical approach based on the Artery-first approach and adapted to the layout of the robot arm. The area between superior mesenteric artery and superior mesenteric vein was used as an intermediate area to treat the uncinate process of the pancreas in order to reduce perioperative complications and achieve better surgical results. However, the safety and effectiveness of intermediate approach have not been verified,in this prospective clinical study, the investigators will use a robotic surgical platform to perform robot-assisted pancreaticoduodenectomy surgery through the intermediate approach to verify its safety and efficacy.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Over 18 years old
  • Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy
  • No obvious arterial invasion, no obvious venous invasion or vein invasion but can be replaced
  • No distant transfer
  • Complete clinical data

Exclusion Criteria5

  • With tumors of other organs
  • Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs
  • Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery
  • Preoperative adjuvant therapy was given
  • Clinical data are seriously missing

Interventions

PROCEDUREIntermediate approach

The area between superior mesenteric vein and superior mesenteric artery was defined as the intermediate area and dissection was performed in this area to achieve the removal of the uncinate process of pancreas.

PROCEDUREStandard approach

The key point of surgery in the standard approach group was to first reveal portal vein-superior mesenteric vein and gradually complete the the resection of the uncinate process of pancreas based on the reference of portal vein-superior mesenteric vein.


Locations(1)

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05660915


Related Trials