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

April 8, 2021 updated by: Kai Qin, Ruijin Hospital

Prospective Cohort Study Comparing Robotic and Open Surgery for 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

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: 670902 0086-(0)21-64370045
  • Email: qinkai310@sina.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1 year overall survival rate
Time Frame: 1 year post-operation
1 year post-operation
3 years overall survival rate
Time Frame: 3 years post-operation
3 years post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: Within 90 days or before discharge
pancreatic fistula, bile leakage, hemorrhage, DGE, etc
Within 90 days or before discharge
1, 3years disease free survival rate
Time Frame: 1,3years post-operation
1,3years post-operation

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Kai Qin, Ruijin Hospital

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 Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (ACTUAL)

December 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HBP-RWR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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