NCT07147374

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

8.2 years

First QC Date

August 20, 2025

Last Update Submit

August 28, 2025

Conditions

Pancreatic CancerNeoadjuvant TherapyRobotic Surgery

Keywords

Pancreatic cancerNeoadjuvant therapyRobotic surgeryOpen surgery

Outcome Measures

Primary Outcomes (1)

  • Overall complication

    The complication occurred within 90 days after the surgery

    Until the 90 days after surgery

Secondary Outcomes (4)

  • Clinically relevant postoperative pancreatic fistula

    Until the 90 days after surgery

  • Postoperative pancreatectomy hemorrhage

    Until the 90 days after surgery

  • Disease-free survival

    Up to 2 years after the surgery

  • Overall survival

    Up to 2 years after surgery

Study Arms (2)

Robotic surgery

Patients who receive robotic pancreatic resection

Open surgery

Patients who receive open pancreatic resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pancreatic cancer who received neoadjuvant therapy and then received surgical resection

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

August 29, 2025

Study Start

February 1, 2017

Primary Completion

April 30, 2025

Study Completion

July 31, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)