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A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

Primary Purpose

Pancreatic Cancer, Common Bile Duct Diseases, Periampullary Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic pancreaticoduodenectomy
Robot Pancreaticoduodenectomy
Sponsored by
The First Affiliated Hospital of University of South China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Robot pancreaticoduodenectomy, laparoscopic pancreaticoduodenectomy, randomized controlled trial, Safety and Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    laparoscopic pancreaticoduodenectomy group

    Robot Pancreaticoduodenectomy

    Arm Description

    The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.

    The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure.

    Outcomes

    Primary Outcome Measures

    Rate of long-term Survival
    Survival will be documented 3 years after surgery

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    February 23, 2023
    Last Updated
    February 23, 2023
    Sponsor
    The First Affiliated Hospital of University of South China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05755607
    Brief Title
    A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD
    Official Title
    A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2028 (Anticipated)
    Study Completion Date
    July 1, 2031 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of University of South China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    laparoscopic pancreaticoduodenectomy(LPD) and Robot Pancreaticoduodenectomy (RPD), as two minimally invasive methods of pancreaticoduodenectomy(PD), have obvious advantages over traditional open pancreaticoduodenectomy(OPD) in terms of reducing surgical trauma and hospitalization time, but there are few studies on their perioperative safety and prognostic effects.However, there are few studies on the perioperative safety and prognostic effects of both procedures. In this trial, the perioperative data and prognosis of both procedures were collected and analyzed through a prospective, multicenter approach to investigate the advantages and disadvantages of both procedures.
    Detailed Description
    In this trial, subjects proposed for PD were randomly divided into two groups, LPD and RPD, according to inclusion and exclusion criteria. Patients in both groups were operated and received perioperative management under the same surgical team and were operated according to the standard PD surgical approach. Subsequently, perioperative clinical data and long-term prognostic data of subjects in both groups will be collected and statistically analyzed to explore a better surgical approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer, Common Bile Duct Diseases, Periampullary Carcinoma
    Keywords
    Robot pancreaticoduodenectomy, laparoscopic pancreaticoduodenectomy, randomized controlled trial, Safety and Efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The key difference in treatment between the two groups is the surgical approach, with the LPD group undergoing laparoscopic-assisted pancreaticoduodenectomy and the RPD group undergoing robotic-assisted pancreaticoduodenectomy, with all treatments remaining the same except for the surgical approach.
    Masking
    Outcomes Assessor
    Masking Description
    The way of surgery.
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    laparoscopic pancreaticoduodenectomy group
    Arm Type
    Other
    Arm Description
    The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.
    Arm Title
    Robot Pancreaticoduodenectomy
    Arm Type
    Other
    Arm Description
    The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure.
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic pancreaticoduodenectomy
    Intervention Description
    The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.
    Intervention Type
    Procedure
    Intervention Name(s)
    Robot Pancreaticoduodenectomy
    Intervention Description
    The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure.
    Primary Outcome Measure Information:
    Title
    Rate of long-term Survival
    Description
    Survival will be documented 3 years after surgery
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Unplanned re-admission rate after discharge within 30 days
    Description
    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
    Time Frame
    3 months
    Title
    Incidence of postoperative complications
    Description
    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
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guodong Chen, PhD
    Phone
    (+86)15211450345
    Email
    Chenguodong@usc.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Danjun Chen, PhD
    Phone
    (+86)13789353900
    Email
    nhfykyb@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guodong Chen, PhD
    Organizational Affiliation
    The First Affiliated Hospital of University of South China
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

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