Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant TreatmentNCT06372886
Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment
An observational study of Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment, run by Seoul National University Hospital.
Trial summary
1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT). 2. Read more about this study
- Who is it for?
- Ages Up to 79 years
- Conditions the study is for
- Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment
- What is being tested?
- portal/superior vein resection
- Type of treatment
- Surgery or procedure
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Mar 2024
- 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 Up to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study retrospectively included 264 pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital in Korea. Among 264 patients, we included 113 patients with resectable and borderline resectable pancreatic ductal adenocarcinoma with venous involvement who responded to NAT and underwent curative PD.
Who may be able to join
- Pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital
Who cannot join
- Metastatic unresectable and locally advanced pancreatic cancer
- Resectable pancreatic cancer without portal/superior mesenteric vein invasion
- Cancer aggravation after neoadjuvant treatment
- Portal/superior mesenteric vein encasing and narrowing after neoadjuvant treatment
- Patients who underwent palliative surgery
- Non-pancreatic ductal adenocarcinoma patients
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- Patients who death within 30 days of surgery
- Loss of follow-up patients
- Patients who underwent resection for suspected main artery and adjacent organ invasion
About this study
- There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).
- There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.
- PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.
- We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement.
- Being tested
- portal/superior vein resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portal/superior vein resectionProcedure or surgery
portal/superior vein resection
| Study group | Role | What they receive |
|---|---|---|
| Preservation of portal/superior mesenteric vein | Not described Receives: Procedure: portal/superior vein resection | |
| Resection of portal/superior mesenteric vein | Not described Receives: Procedure: portal/superior vein resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
from diagnosis to any cause of death
Measured: assessed up to 60months
5-year portal/superior mesenteric vein stenosis free survival
from surgery to stenosis
Measured: assessed up to 60months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jan 2012
- Primary completion1 Jan 2022
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant TreatmentStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Jang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372886
- Sponsor's protocol ID
- 2402-147-1516
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT06372886
- Acronym / sponsor ID
- 2402-147-1516
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Apr 2024 (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.
- There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).
- There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.
- PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.
- We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preservation of portal/superior mesenteric vein | – | Procedure: portal/superior vein resection |
| Resection of portal/superior mesenteric vein | – | Procedure: portal/superior vein resection |
Who may qualify
- Ages
- Up to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study retrospectively included 264 pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital in Korea. Among 264 patients, we included 113 patients with resectable and borderline resectable pancreatic ductal adenocarcinoma with venous involvement who responded to NAT and underwent curative PD.
Key inclusion criteria (1 listed)
- Pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital
Key exclusion criteria (9 listed)
- Metastatic unresectable and locally advanced pancreatic cancer
- Resectable pancreatic cancer without portal/superior mesenteric vein invasion
- Cancer aggravation after neoadjuvant treatment
- Portal/superior mesenteric vein encasing and narrowing after neoadjuvant treatment
- Patients who underwent palliative surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| portal/superior vein resectionportal/superior vein resection | Procedure or surgery | Preservation of portal/superior mesenteric vein, Resection of portal/superior mesenteric vein |
Primary outcome
5-year overall survival
Time frame: assessed up to 60months
from diagnosis to any cause of death
5-year portal/superior mesenteric vein stenosis free survival
Time frame: assessed up to 60months
from surgery to stenosis
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 18 Apr 2024.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment, run by Seoul National University Hospital.
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 1 inclusion and 9 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
5-year overall survival (time frame: assessed up to 60months). The study lists 2 primary outcomes in all. 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 18 Apr 2024.