Pancreatic CancerNCT07147374
Robotic Versus Open Surgery Following Neoadjuvant Therapy in Pancreatic Cancer: Evaluation of Safety and Oncologic Outcomes
An observational study of Pancreatic Cancer and Neoadjuvant Therapy, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Neoadjuvant Therapy, Robotic Surgery
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic cancer who received neoadjuvant therapy and then received surgical resection
Who may be able to join
- Age over 18 years.
- Received neoadjuvant chemotherapy.
- Postoperative pathology confirmed pancreatic cancer.
- Underwent either open or robotic surgery.
Who cannot join
- Intraoperative discovery of unresectable tumor or presence of distant metastasis.
- ASA score ≥ 4.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Peking Union Medical College Hospital (PUMCH)
Beijing, Beijing Municipality, 100730
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Neoadjuvant Therapy, Robotic Surgery
- Keywords
- Pancreatic cancer, Neoadjuvant therapy, Robotic surgery, Open surgery
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery | Patients who receive robotic pancreatic resection | |
| Open surgery | Patients who receive open pancreatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complication
The complication occurred within 90 days after the surgery
Measured: Until the 90 days after surgery
Secondary outcomes (4)
Clinically relevant postoperative pancreatic fistula
Grade B or C pancreatic fistula within 90 days after surgery
Measured: Until the 90 days after surgery
Postoperative pancreatectomy hemorrhage
Hemorrhage occurred within 90 days after surgery
Measured: 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.
Measured: 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.
Measured: Up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Feb 2017
- Primary completion30 Apr 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147374
- Sponsor's protocol ID
- Robotic surgery
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Open Surgery Following Neoadjuvant Therapy in Pancreatic Cancer: Evaluation of Safety and Oncologic Outcomes
- ClinicalTrials.gov ID
- NCT07147374
- Acronym / sponsor ID
- Robotic surgery
- Conditions
- Pancreatic Cancer, Neoadjuvant Therapy, Robotic Surgery
- Keywords
- Pancreatic cancer, Neoadjuvant therapy, Robotic surgery, Open surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery | – | –Patients who receive robotic pancreatic resection |
| Open surgery | – | –Patients who receive open pancreatic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic cancer who received neoadjuvant therapy and then received surgical resection
Key inclusion criteria (4 listed)
- Age over 18 years.
- Received neoadjuvant chemotherapy.
- Postoperative pathology confirmed pancreatic cancer.
- Underwent either open or robotic surgery.
Key exclusion criteria (2 listed)
- Intraoperative discovery of unresectable tumor or presence of distant metastasis.
- ASA score ≥ 4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall complication
Time frame: Until the 90 days after surgery
The complication occurred within 90 days after the surgery
4 secondary outcomes
Clinically relevant postoperative pancreatic fistula
Time frame: Until the 90 days after surgery
Postoperative pancreatectomy hemorrhage
Time frame: Until the 90 days after surgery
Disease-free survival
Time frame: Up to 2 years after the surgery
Overall survival
Time frame: Up to 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Neoadjuvant Therapy, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complication (time frame: Until the 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.