2017-02-01
2025-04-30
2025-07-31
56
NCT07147374
Peking Union Medical College Hospital
Peking Union Medical College Hospital
OBSERVATIONAL
Robotic Versus Open Surgery Following Neoadjuvant Therapy in Pancreatic Cancer: Evaluation of Safety and Oncologic Outcomes
The feasibility and safety of minimally invasive surgery in cases after neoadjuvant therapy were unclear. It is worth exploring the safety of robotic resection for pancreatic cancer following neoadjuvant therapy. The investigators investigated the comparative outcomes of robotic and open surgery in the management of pancreatic cancer after NAT, exploring the feasibility and safety of robotic procedures in complex cases of pancreatic cancer, and providing evidence-based guidance for clinical practice.
Currently, most studies focus on upfront resectable pancreatic cancer, benign or low-grade malignant tumors, demonstrating that robotic surgery can shorten postoperative hospital stays, reduce intraoperative blood loss, and achieve oncological outcomes comparable to open surgery. The feasibility and safety of minimally invasive surgery in cases after NAT were unclear. Both the Miami international evidence-based consensus and the Brescia international validated European guidelines indicate that current data are insufficient to recommend minimally invasive approaches for pancreatic cancer resection following NAT, highlighting the need for additional research. Therefore, it is worth exploring the safety of robotic resection for pancreatic cancer following NAT. The investigators investigated the comparative outcomes of robotic and open surgery in the management of pancreatic cancer after NAT, exploring the feasibility and safety of robotic procedures in complex cases of pancreatic cancer, and providing evidence-based guidance for clinical practice.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2025-08-20 | N/A | 2025-08-28 |
2025-08-28 | N/A | 2025-08-29 |
2025-08-29 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
: Robotic surgery Patients who receive robotic pancreatic resection | |
: Open surgery Patients who receive open pancreatic resection |
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Overall complication | The complication occurred within 90 days after the surgery | Until the 90 days after surgery |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Clinically relevant postoperative pancreatic fistula | Grade B or C pancreatic fistula within 90 days after surgery | Until the 90 days after surgery |
Postoperative pancreatectomy hemorrhage | Hemorrhage occurred within 90 days after surgery | Until the 90 days after surgery |
Disease-free survival | The length of time from the completion of surgery until the recurrence of cancer, the occurrence of metastasis, death from any cause, or to the last follow-up. | Up to 2 years after the surgery |
Overall survival | The length of time from the date of surgery to death from any cause or to the last follow-up. | Up to 2 years after surgery |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available