Carcinoma, Pancreatic DuctalNCT05723978
Selective Extended Dissection in Different Types of Pancreatic Head Cancer: A Retrospective Cohort Study.
An observational study of Carcinoma, Pancreatic Ductal, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) is a highly malignant tumor with relatively poor survival. Surgery is the first choice for the treatment of patients with early pancreatic cancer. However, the surgical approach and the extent of resection for patients with pancreatic cancer are controversial at present. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- Selective extended dissection of pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 1 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery
Who may be able to join
- 1) Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery.
- 2) Patients received radical surgery (R0) and had complete photos or videos of the operation.
Who cannot join
- 1) The operation records as well as related photo or video data could not reflect the surgical approach and the extent of resection.
- 2) Patients with incomplete clinical, pathological, imaging and follow-up information.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 30000
About this study
Pancreatic ductal adenocarcinoma (PDAC) is a highly malignant tumor with relatively poor survival. Surgery is the first choice for the treatment of patients with early pancreatic cancer. However, the surgical approach and the extent of resection for patients with pancreatic cancer are controversial at present.
The investigators optimized the procedure of standard pancreaticoduodenectomy to selective extended dissection (SED), which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor. The investigators retrospectively analyzed the clinicopathological data of patients with pancreatic adenocarcinoma who underwent radical surgery in our center from 2011 to 2020. Patients who underwent standard dissection (SD) were matched 2:1 to those who underwent SED using propensity score matching (PSM). The log-rank test and cox regression model were used to analyze survival data. In addition, statistical analyses were performed for the perioperative complications, postoperative pathology and recurrence pattern.
- Conditions
- Carcinoma, Pancreatic Ductal
- Being tested
- Selective extended dissection of pancreaticoduodenectomy
- Medical subject headings
- Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective extended dissection of pancreaticoduodenectomyProcedure or surgery
An optimized procedure of pancreaticoduodenectomy which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor.
| Study group | Role | What they receive |
|---|---|---|
| Selective extended dissection (SED) group | Not described Receives: Procedure: Selective extended dissection of pancreaticoduodenectomy | |
| Standard dissection (SD) group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: From the day the patient received surgery to the time the patient was diagnosed with postoperative recurrence, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Jan 2011
- Primary completion1 Jul 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Pancreatic DuctalStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 520 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723978
- Sponsor's protocol ID
- Panc-2023129
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Guo X, Song Y, Xu P, Zhu W, Wang H, Zhou Y, Huang C, Hao J, Gao S. Selective extended dissection for pancreaticoduodenectomy is associated with better survival in pancreatic cancer patients: retrospective cohort study. Int J Surg. 2023 Jul 1;109(7):1852-1862. doi: 10.1097/JS9.0000000000000437.
PubMed 37195787
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Extended Dissection in Different Types of Pancreatic Head Cancer: A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05723978
- Acronym / sponsor ID
- Panc-2023129
- Conditions
- Carcinoma, Pancreatic Ductal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 Feb 2023 (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.
Pancreatic ductal adenocarcinoma (PDAC) is a highly malignant tumor with relatively poor survival. Surgery is the first choice for the treatment of patients with early pancreatic cancer. However, the surgical approach and the extent of resection for patients with pancreatic cancer are controversial at present.
The investigators optimized the procedure of standard pancreaticoduodenectomy to selective extended dissection (SED), which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor. The investigators retrospectively analyzed the clinicopathological data of patients with pancreatic adenocarcinoma who underwent radical surgery in our center from 2011 to 2020. Patients who underwent standard dissection (SD) were matched 2:1 to those who underwent SED using propensity score matching (PSM). The log-rank test and cox regression model were used to analyze survival data. In addition, statistical analyses were performed for the perioperative complications, postoperative pathology and recurrence pattern.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective extended dissection (SED) group | – | Procedure: Selective extended dissection of pancreaticoduodenectomy |
| Standard dissection (SD) group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery
Key inclusion criteria (2 listed)
- 1) Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery.
- 2) Patients received radical surgery (R0) and had complete photos or videos of the operation.
Key exclusion criteria (2 listed)
- 1) The operation records as well as related photo or video data could not reflect the surgical approach and the extent of resection.
- 2) Patients with incomplete clinical, pathological, imaging and follow-up information.
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 |
|---|---|---|
| Selective extended dissection of pancreaticoduodenectomyAn optimized procedure of pancreaticoduodenectomy which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor. | Procedure or surgery | Selective extended dissection (SED) group |
Primary outcome
Disease-free survival (DFS)
Time frame: From the day the patient received surgery to the time the patient was diagnosed with postoperative recurrence, assessed up to 36 months.
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 13 Feb 2023.
- Derived from this study: PubMed 37195787Guo X, Song Y, Xu P, Zhu W, Wang H, Zhou Y, Huang C, Hao J, Gao S. Selective extended dissection for pancreaticoduodenectomy is associated with better survival in pancreatic cancer patients: retrospective cohort study. Int J Surg. 2023 Jul 1;109(7):1852-1862. doi: 10.1097/JS9.0000000000000437.
- Individual participant dataSharing planned: Yes
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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 Carcinoma, Pancreatic Ductal, run by Tianjin Medical University Cancer Institute and 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 2 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 13 Feb 2023. 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?
Disease-free survival (DFS) (time frame: From the day the patient received surgery to the time the patient was diagnosed with postoperative recurrence, assessed up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723978, which also lists 1 linked publication.
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 13 Feb 2023.