A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05755607
• Other study ID #: USC-4310-3
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 1, 2031

Study information

• Verified date: February 2023
• Source: The First Affiliated Hospital of University of South China
• Contact: Guodong Chen, PhD
• Phone: (+86)15211450345
• Email: Chenguodong[@]usc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2031
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Common Bile Duct Diseases
• Pancreatic Cancer
• Periampullary Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of University of South China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of long-term Survival	Survival will be documented 3 years after surgery	3 years
Secondary	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
Secondary	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