NCT05755607

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
62mo left

Started Jun 2023

Longer than P75 for not_applicable pancreatic-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Jun 2023Jul 2031

First Submitted

Initial submission to the registry

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

March 6, 2023

Status Verified

February 1, 2023

Enrollment Period

5 years

First QC Date

February 23, 2023

Last Update Submit

February 23, 2023

Conditions

Pancreatic CancerCommon Bile Duct DiseasesPeriampullary Carcinoma

Keywords

Robot pancreaticoduodenectomylaparoscopic pancreaticoduodenectomyrandomized controlled trialSafety and Efficacy

Outcome Measures

Primary Outcomes (1)

  • Rate of long-term Survival

    Survival will be documented 3 years after surgery

    3 years

Secondary Outcomes (2)

  • Unplanned re-admission rate after discharge within 30 days

    3 months

  • Incidence of postoperative complications

    2 months

Study Arms (2)

laparoscopic pancreaticoduodenectomy group

OTHER

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

Procedure: laparoscopic pancreaticoduodenectomy

Robot Pancreaticoduodenectomy

OTHER

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

Procedure: Robot Pancreaticoduodenectomy

Interventions

laparoscopic pancreaticoduodenectomyPROCEDURE

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

laparoscopic pancreaticoduodenectomy group
Robot PancreaticoduodenectomyPROCEDURE

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

Robot Pancreaticoduodenectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic NeoplasmsCommon Bile Duct Diseases

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBile Duct DiseasesBiliary Tract Diseases

Study Officials

  • Guodong Chen, PhD

    The First Affiliated Hospital of University of South China

    STUDY CHAIR

Central Study Contacts

Guodong Chen, PhD

CONTACT

(+86)15211450345Chenguodong@usc.edu.cn

Danjun Chen, PhD

CONTACT

(+86)13789353900nhfykyb@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The way of surgery.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

July 1, 2031

Last Updated

March 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share