Trials
Search / Trial NCT05660915

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

Launched by THE FIRST AFFILIATED HOSPITAL OF UNIVERSITY OF SOUTH CHINA · Dec 14, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Robot Assisted Pancreaticoduodenectomy Superior Mesenteric Artery First Approach Intermediate Approach Safety And Efficacy Randomized Controlled Trial

ClinConnect Summary

This clinical trial is studying a new way to perform a surgery called pancreaticoduodenectomy, which is used to treat pancreatic cancer and related conditions. The researchers are focusing on a method called the "intermediate approach," which uses robotic assistance to carefully remove tumors while aiming to reduce complications and improve recovery. This method looks at the area between two important blood vessels to make the surgery safer and more effective.

To participate in this study, individuals must be at least 18 years old and have a tumor in the head of the pancreas, ampulla, or distal common bile duct that looks operable based on imaging tests. They should not have any major involvement of nearby arteries or veins, and there should be no signs of distant spread of cancer. Participants will undergo surgery using a robotic platform, and the trial aims to verify whether this approach is safe and beneficial compared to traditional methods. This study is currently recruiting participants, and it’s important to discuss any potential concerns with a healthcare provider before joining.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

Trial Officials

Guodong Chen, PhD

Study Chair

The First Affiliated Hospital of University of South China

About The First Affiliated Hospital Of University Of South China

The First Affiliated Hospital of University of South China is a leading clinical research institution dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. As a prominent teaching hospital, it integrates cutting-edge research with comprehensive healthcare services, fostering collaboration among multidisciplinary teams of healthcare professionals. Committed to ethical standards and patient safety, the hospital conducts a wide range of clinical studies across various therapeutic areas, aiming to translate scientific findings into effective treatments. With a strong focus on enhancing health outcomes, the First Affiliated Hospital of University of South China plays a pivotal role in the development of new medical interventions and the overall improvement of public health.

Locations

Hengyang, Hunan, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials