A Prospective Study On The Safety And Efficacy Of Robot-assisted Pancreaticoduodenectomy

Study Overview

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.

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.

Pancreatic Cancer
Common Bile Duct Diseases
Periampullary Carcinoma

PROCEDURE: Robot-assisted Pancreaticoduodenectomy

USC-4310

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-02-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-02-23
First Submitted that Met QC Criteria 2023-02-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-03-06
First Posted (ACTUAL) 2023-03-06	Results First Posted N/A	Last Verified 2023-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Robot-assisted Pancreaticoduodenectomy By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure	PROCEDURE: Robot-assisted Pancreaticoduodenectomy By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure

Participant Group/Arm

Intervention/Treatment

OTHER: Robot-assisted Pancreaticoduodenectomy

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

PROCEDURE: Robot-assisted Pancreaticoduodenectomy

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 Outcome Measures	Measure Description	Time Frame
Rate of long-term Survival	survival will be documented 3 years after surgery	3 years

Secondary Outcome Measures	Measure Description	Time Frame
Unplanned re-admission rate after discharge within 30 days	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	3 months
Incidence of postoperative complications	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	2 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Guodong Chen, PhD

Phone Number: (+86)15211450345

Email: Chenguodong@usc.edu.cn

Study Contact Backup

Name: Danjun Chen, PhD

Phone Number: (+86)13789353900

Email: nhfykyb@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Guodong Chen, PhD, The First Affiliated Hospital of University of South China

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record