Robotic Versus Open Surgery Following Neoadjuvant Therapy in Pancreatic Cancer: Evaluation of Safety and Oncologic Outcomes

Completed

• Conditions: Pancreatic Cancer; Neoadjuvant Therapy; Robotic Surgery

• Registration Number: NCT07147374
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Age over 18 years.
• Received neoadjuvant chemotherapy.
• Postoperative pathology confirmed pancreatic cancer.
• Underwent either open or robotic surgery.

Exclusion Criteria

• Intraoperative discovery of unresectable tumor or presence of distant metastasis.
• ASA score ≥ 4.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall complication	Until the 90 days after surgery	The complication occurred within 90 days after the surgery

Secondary Outcome Measures

Name	Time	Method
Clinically relevant postoperative pancreatic fistula	Until the 90 days after surgery	Grade B or C pancreatic fistula within 90 days after surgery
Postoperative pancreatectomy hemorrhage	Until the 90 days after surgery	Hemorrhage occurred within 90 days after surgery
Disease-free survival	Up to 2 years after the surgery	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.
Overall survival	Up to 2 years after surgery	The length of time from the date of surgery to death from any cause or to the last follow-up.

Trial Locations

Locations (1)

Department of General Surgery, Peking Union Medical College Hospital (PUMCH); 🇨🇳 Beijing, Beijing Municipality, China