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Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic Cancer


2019-03-01


2022-12


2024-12


300

Study Overview

Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic Cancer

The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.

N/A

  • Pancreatic Ductal Adenocarcinoma
  • Minimally Invasive Surgery
  • PROCEDURE: robotic surgery
  • PROCEDURE: open surgery
  • HBP-RWR-001

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

2019-11-29  

N/A  

2021-04-08  

2019-12-24  

N/A  

2021-04-09  

2019-12-26  

N/A  

2021-04  

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:
Non Randomized


Interventional Model:
Parallel


Masking:
Single


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: robotic pancreatectomy

robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

PROCEDURE: robotic surgery

  • Pancreatectomy with robotic assisted system
ACTIVE_COMPARATOR: open surgery

open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)

PROCEDURE: open surgery

  • Traditional open pancreatectomy
Primary Outcome MeasuresMeasure DescriptionTime Frame
1 year overall survival rate1 year post-operation
3 years overall survival rate3 years post-operation
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Postoperative Complicationspancreatic fistula, bile leakage, hemorrhage, DGE, etcWithin 90 days or before discharge
1, 3years disease free survival rate1,3years post-operation

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: Kai Qin, Doctor

Phone Number: 0086-(0)21-64370045

Email: qinkai310@sina.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:

    Inclusion Criteria:

  • Diagnosed pancreatic ductal adenocarcinoma
  • Patients and their families volunteered to test and signed informed consent.

  • Exclusion Criteria:

  • Preoperative exclusion:

  • 1. Patients with metastasis (M1) 2. Patients with tumor recurrence 3. Patients with artery and/or vein invasion and can't perform radical resection and reconstruction 4. Patients with poor cardiopulmonary function cannot tolerate surgery; 5. receive neoadjuvant radiotherapy and chemotherapy before surgery; 6. The patient or family member refuses to join the group; 7. Pregnant patients
  • Intraoperative exclusion:

  • 1. Intraoperative exploration of metastases in other parts besides the primary lesion 2. Other organs malignant tumors metastasize to the pancreas
  • Postoperative exclusion:

  • 1. pathology confirmed non-pancreatic ductal adenocarcinoma

Collaborators and Investigators

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

  • Shanghai Jiao Tong University School of Medicine

  • PRINCIPAL_INVESTIGATOR: Kai Qin, Ruijin Hospital

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