A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy

• Sponsor: The First Affiliated Hospital of University of South China (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05755594
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Anticipated Duration (Months): 96

Study Details

Study Description

Brief Summary

Further studies are needed to investigate the prognosis and perioperative safety of patients undergoing robotic-assisted pancreaticoduodenectomy. In this study, clinical data and prognostic data of patients undergoing this procedure were prospectively collected and analyzed to explore its safety and efficacy.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer; Common Bile Duct Diseases; Periampullary Carcinoma	Procedure: Robot-assisted Pancreaticoduodenectomy	N/A

Detailed Description

Perioperative clinical data and prognostic data of patients undergoing robotic-assisted pancreaticoduodenectomy were collected and analyzed to explore the safety and efficacy of this surgical approach.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: The way of surgery.
• Primary Purpose: Treatment
• Official Title: A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2028
• Anticipated Study Completion Date: Jun 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Other: Robot-assisted Pancreaticoduodenectomy By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure	Procedure: Robot-assisted Pancreaticoduodenectomy; By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure

Outcome Measures

Primary Outcome Measures

1. Rate of long-term Survival [3 years]

   survival will be documented 3 years after surgery

Secondary Outcome Measures

1. Unplanned re-admission rate after discharge within 30 days [3 months]

   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

2. Incidence of postoperative complications [2 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital of University of South China
• ClinicalTrials.gov Identifier: NCT05755594
• Other Study ID Numbers: USC-4310
• First Posted: Mar 6, 2023
• Last Update Posted: Mar 6, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The First Affiliated Hospital of University of South China: Robot-assisted pancreaticoduodenectomy; Safety and Efficacy; randomized controlled trial
• Additional relevant MeSH terms: Bile Duct Diseases; Common Bile Duct Diseases

Study Results

No Results Posted as of Mar 6, 2023