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OpenTrials
Completed

NCT Number: NCT07147374

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoadjuvant Therapy Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Robotic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of General Surgery, Peking Union Medical College Hospital (PUMCH)

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall complication

    Time frame: Until the 90 days after surgery

    The complication occurred within 90 days after the surgery

Secondary outcomes

  1. Clinically relevant postoperative pancreatic fistula

    Time frame: Until the 90 days after surgery

    Grade B or C pancreatic fistula within 90 days after surgery

  2. Postoperative pancreatectomy hemorrhage

    Time frame: Until the 90 days after surgery

    Hemorrhage occurred within 90 days after surgery

  3. Disease-free survival

    Time frame: 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.

  4. Overall survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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