A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer; Common Bile Duct Diseases; Periampullary Carcinoma
• Intervention / Treatment: Procedure: laparoscopic pancreaticoduodenectomy; Procedure: Robot Pancreaticoduodenectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guodong Chen, PhD; Phone Number: (+86)15211450345; Email: Chenguodong@usc.edu.cn
• Study Contact Backup: Name: Danjun Chen, PhD; Phone Number: (+86)13789353900; Email: nhfykyb@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: laparoscopic pancreaticoduodenectomy group; The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.	Procedure: laparoscopic pancreaticoduodenectomy; The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.
Other: Robot Pancreaticoduodenectomy; 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; The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of long-term Survival	Survival will be documented 3 years after surgery	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	2 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of University of South China
• Investigators: Study Chair: Guodong Chen, PhD, The First Affiliated Hospital of University of South China

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2028
• Study Completion (Anticipated): July 1, 2031

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; Safety and Efficacy; laparoscopic pancreaticoduodenectomy; Robot pancreaticoduodenectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases
• Other Study ID Numbers: USC-4310-3

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