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

Plain Language Summary

Simplified for easier understanding

This study evaluates a specific surgical approach — called the artery-first intermediate approach — used during robot-assisted removal of part of the pancreas (pancreaticoduodenectomy). Researchers want to see whether this technique leads to better outcomes compared to standard approaches. **You may be eligible if...** - You are over 18 years old - Imaging has found a tumor in the head of the pancreas, the area around the pancreatic duct exit (ampullary region), or the lower part of the bile duct - The tumor is planned to be removed with a pancreaticoduodenectomy (Whipple procedure) - The tumor has not invaded the main arteries nearby and has not spread to distant organs - Your complete medical history is available **You may NOT be eligible if...** - You have another active cancer in a different organ - You are not healthy enough to tolerate anesthesia or major surgery due to heart or lung problems - During surgery, it is found that the cancer has spread to nearby organs or cannot be fully removed - You have received chemotherapy or radiation before this surgery - Key medical data is missing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT05660915


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