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

NCT ID: NCT05755594

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2031-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer Common Bile Duct Diseases Periampullary Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The way of surgery.

Study Groups

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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

Group Type OTHER

Robot-assisted Pancreaticoduodenectomy

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of University of South China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guodong Chen, PhD

Role: STUDY_CHAIR

The First Affiliated Hospital of University of South China

Central Contacts

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Guodong Chen, PhD

Role: CONTACT

(+86)15211450345

Danjun Chen, PhD

Role: CONTACT

(+86)13789353900

Other Identifiers

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USC-4310

Identifier Type: -

Identifier Source: org_study_id

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