Using a new surgical approach for robot-assisted pancreatic surgery
A Prospective Clinical Study of the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy Using an Artery-first Intermediate Approach
NA · The First Affiliated Hospital of University of South China · NCT05660915
This study is testing a new surgical method for robot-assisted surgery on the pancreas to see if it works better and is safer for people with pancreatic cancer compared to the standard approach.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of University of South China (other) |
| Locations | 1 site (Hengyang, Hunan) |
| Trial ID | NCT05660915 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of an intermediate approach in robot-assisted pancreaticoduodenectomy for patients with pancreatic cancer and related conditions. Participants will be randomized into two groups: one receiving the standard surgical approach and the other receiving the new intermediate approach. The study aims to assess outcomes such as intraoperative bleeding, postoperative complications, and long-term prognosis. All surgeries will be performed by the same surgical team following standardized protocols to ensure consistency in care.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with tumors in the head of the pancreas, ampulla, or distal common bile duct that can be treated with pancreaticoduodenectomy.
Not a fit: Patients with tumors in other organs or those unable to tolerate anesthesia or surgery due to severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for patients undergoing pancreatic surgery.
How similar studies have performed: While the artery-first approach has shown promise in clinical practice, the intermediate approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 obvious arterial invasion, no obvious venous invasion or vein invasion but can be replaced * No distant transfer * Complete clinical data 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 * Clinical data are seriously missing
Where this trial is running
Hengyang, Hunan
- The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (RECRUITING)
Study contacts
- Study coordinator: Guodong Chen, PhD
- Email: Chenguodong@usc.edu.cn
- Phone: (+86)15211450345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Cancer, Common Bile Duct Diseases, Periampullary Carcinoma, Robot-assisted pancreaticoduodenectomy, Superior mesenteric artery first approach, Intermediate approach, Safety and Efficacy, randomized controlled trial