A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy

Further studies are needed to investigate the prognosis and perioperative safety of patients undergoing robotic-assisted pancreaticoduodenectomy. In this study, clinical data and prognostic data of patients undergoing this procedure were prospectively collected and analyzed to explore its safety and efficacy.

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Key information

Conditions

Pancreatic Cancer Bile Duct Diseases Biliary Tract Diseases Common Bile Duct Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Periampullary Carcinoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Perioperative clinical data and prognostic data of patients undergoing robotic-assisted pancreaticoduodenectomy were collected and analyzed to explore the safety and efficacy of this surgical approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 distant transfer
No significant vascular invasion was received

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

Treatment and study plan

Robot-assisted Pancreaticoduodenectomy

Procedure

By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure

Primary outcomes

Rate of long-term Survival

Time frame: 3 years

survival will be documented 3 years after surgery

Secondary outcomes

Unplanned re-admission rate after discharge within 30 days

Time frame: 3 months

Serious discomfort requiring re-admission within 30 days after discharge will be recorded, and the safety of the surgical method will be evaluated by this indicator
Incidence of postoperative complications

Time frame: 2 months

During hospitalization, common complications of pancreaticoduodenectomy, such as postoperative pancreatic fistula, bile leak, gastrojejunostomy leak, and delayed gastric emptying, will be recorded according to the international diagnostic criteria to evaluate the short-term safety of this surgical approach

Study contacts

Contact information is provided by the study sponsor or research team.

Danjun Chen, PhD

CONTACT

[email protected]

(+86)13789353900

Guodong Chen, PhD

CONTACT

[email protected]

(+86)15211450345

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of University of South China

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2031
First posted: Mar 6, 2023
Registry last updated: Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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