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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital of University of South China
RECRUITING
Hengyang
Contact Information
Primary
Guodong Chen, PhD
Chenguodong@usc.edu.cn
(+86)15211450345
Backup
Danjun Chen, PhD
nhfykyb@163.com
(+86)13789353900
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 80
Treatments
Experimental: The intermediate approach
The key point of surgery in the standard approach group was to first reveal portal vein-superior mesenteric vein and gradually complete the resection of the uncinate process of pancreas based on the reference of portal vein-superior mesenteric vein.
Other: The standard approach
The area between superior mesenteric artery and superior mesenteric vein was defined as the intermediate area and dissection was performed in this area to achieve the removal of the uncinate process of pancreas.
Sponsors
Leads: The First Affiliated Hospital of University of South China

This content was sourced from clinicaltrials.gov

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