Pancreas CancerNCT06206382
Surgical Results of Resection of Locally Advanced Pancreatic Cancer
An observational study of Pancreas Cancer, run by Assiut University.
Trial summary
The aim is to compare the surgical outcomes between upfront surgery and surgery after neoadjuvant chemotherapy in terms of morbidity and mortality Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Whipple operation
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2024to Oct 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of borderline respectable pancreatic cancer undergoing Whipple operation
Who may be able to join
- Patients under surgical management for pancreatic cancer
- Patients whose radiological findings are compatible with resectability of the tumour including vascular encasement
Who cannot join
- Patients who are medically unfit for surgery
- Patients whose radioliogical findins suggestive of unresectability of the tumour including vascular abutment or infiltration more than 180 dergree
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Surgical Outcome of Borderline Resectable Pancreatic Cancer: Upfront Surgery Versus Neoadjuvant Chemotherapy (Single Center Experience)
The aim is to compare the surgical outcomes between upfront surgery and surgery after neoadjuvant chemotherapy in terms of morbidity and mortality
Read the detailed description
Pancreatic cancer is the fourth leading cause of cancer death in the United States. While surgical resection remains the only curative option, more than 80% of patients present with unresectable disease. Unfortunately, even among those who undergo resection, the reported median survival is 15-23 mo, with a 5-year survival of approximately 20%. Disappointingly, over the past several decades, despite improvements in diagnostic imaging, surgical technique and chemotherapeutic options, only modest improvements in survival have been realized. Nevertheless, it remains clear that surgical resection is a prerequisite for achieving long-term survival and cure. The concept of borderline resectable pancreatic cancer has evolved from several clinical observations made over decades. It has been recognized for some time that the prognosis for patients undergoing surgical resection for pancreatic ductal adenocarcinoma (PDAC) is highly dependent on margin status, with total gross excision and histologically negative margins (R0 resection) being associated with the best outcomes. Survival for patients who undergo total gross excision but have histologically positive margins (R1 resection) have a reduced survival in most series
- Conditions
- Pancreas Cancer
- Being tested
- Whipple operation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whipple operationProcedure or surgery
Whipple operation is the surgery used for pancreatic head cancer in the form of pancreaticoduodenectomy then reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Upfront surgery for locally advanced pancreatic cancers | Not described Receives: Procedure: Whipple operation | |
| Surgery after neoadjuvant chemotherapy for locally advanced pancreatic cancers | Not described Receives: Procedure: Whipple operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patient death
Measured: 3 years
Secondary outcomes (1)
Morbidity
Surgical complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start5 Jan 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Melad Boshra Yosef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206382
- Sponsor's protocol ID
- Borderline pancreatic cancer
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wang WL, Ye S, Yan S, Shen Y, Zhang M, Wu J, Zheng SS. Pancreaticoduodenectomy with portal vein/superior mesenteric vein resection for patients with pancreatic cancer with venous invasion. Hepatobiliary Pancreat Dis Int. 2015 Aug;14(4):429-35. doi: 10.1016/s1499-3872(15)60400-3.
PubMed 26256089Han S, Choi DW, Choi SH, Heo JS, Han IW, You YH. Long-term outcomes following en bloc resection for pancreatic ductal adenocarcinoma of the head with portomesenteric venous invasion. Asian J Surg. 2021 Jan;44(1):313-320. doi: 10.1016/j.asjsur.2020.07.021. Epub 2020 Sep 21.
PubMed 32972828Lapshyn H, Schulte T, Petruch N, Petrova E, Honselmann K, Deichmann S, Braun R, Kulemann B, Hoeppner J, Rades D, Keck T, Wellner UF, Bausch D, Bolm L. Postoperative Outcomes of Tangential versus Segmental Resection and End-to-end Reconstruction of the Superior Mesenterico-Portal Vein During Pancreatoduodenectomy for Pancreatic Adenocarcinoma: A Single-Center Experience. Anticancer Res. 2021 Oct;41(10):5123-5130. doi: 10.21873/anticanres.15329.
PubMed 34593463Yu XZ, Li J, Fu DL, Di Y, Yang F, Hao SJ, Jin C. Benefit from synchronous portal-superior mesenteric vein resection during pancreaticoduodenectomy for cancer: a meta-analysis. Eur J Surg Oncol. 2014 Apr;40(4):371-8. doi: 10.1016/j.ejso.2014.01.010. Epub 2014 Feb 7.
PubMed 24560302Tewari M. Significance of pathological positive superior mesenteric/portal venous invasion in pancreatic cancer. Hepatobiliary Pancreat Dis Int. 2016 Dec;15(6):572-578. doi: 10.1016/s1499-3872(16)60156-x.
PubMed 27919845
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcome of Borderline Resectable Pancreatic Cancer: Upfront Surgery Versus Neoadjuvant Chemotherapy (Single Center Experience)
- ClinicalTrials.gov ID
- NCT06206382
- Acronym / sponsor ID
- Borderline pancreatic cancer
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 Jan 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.
The aim is to compare the surgical outcomes between upfront surgery and surgery after neoadjuvant chemotherapy in terms of morbidity and mortality
Detailed description
Pancreatic cancer is the fourth leading cause of cancer death in the United States. While surgical resection remains the only curative option, more than 80% of patients present with unresectable disease. Unfortunately, even among those who undergo resection, the reported median survival is 15-23 mo, with a 5-year survival of approximately 20%. Disappointingly, over the past several decades, despite improvements in diagnostic imaging, surgical technique and chemotherapeutic options, only modest improvements in survival have been realized. Nevertheless, it remains clear that surgical resection is a prerequisite for achieving long-term survival and cure. The concept of borderline resectable pancreatic cancer has evolved from several clinical observations made over decades. It has been recognized for some time that the prognosis for patients undergoing surgical resection for pancreatic ductal adenocarcinoma (PDAC) is highly dependent on margin status, with total gross excision and histologically negative margins (R0 resection) being associated with the best outcomes. Survival for patients who undergo total gross excision but have histologically positive margins (R1 resection) have a reduced survival in most series
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront surgery for locally advanced pancreatic cancers | – | Procedure: Whipple operation |
| Surgery after neoadjuvant chemotherapy for locally advanced pancreatic cancers | – | Procedure: Whipple operation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of borderline respectable pancreatic cancer undergoing Whipple operation
Key inclusion criteria (2 listed)
- Patients under surgical management for pancreatic cancer
- Patients whose radiological findings are compatible with resectability of the tumour including vascular encasement
Key exclusion criteria (2 listed)
- Patients who are medically unfit for surgery
- Patients whose radioliogical findins suggestive of unresectability of the tumour including vascular abutment or infiltration more than 180 dergree
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 |
|---|---|---|
| Whipple operationWhipple operation is the surgery used for pancreatic head cancer in the form of pancreaticoduodenectomy then reconstruction | Procedure or surgery | Surgery after neoadjuvant chemotherapy for locally advanced pancreatic cancers, Upfront surgery for locally advanced pancreatic cancers |
Primary outcome
Mortality
Time frame: 3 years
Patient death
1 secondary outcome
Morbidity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Background: PubMed 26256089Wang WL, Ye S, Yan S, Shen Y, Zhang M, Wu J, Zheng SS. Pancreaticoduodenectomy with portal vein/superior mesenteric vein resection for patients with pancreatic cancer with venous invasion. Hepatobiliary Pancreat Dis Int. 2015 Aug;14(4):429-35. doi: 10.1016/s1499-3872(15)60400-3.
- Background: PubMed 32972828Han S, Choi DW, Choi SH, Heo JS, Han IW, You YH. Long-term outcomes following en bloc resection for pancreatic ductal adenocarcinoma of the head with portomesenteric venous invasion. Asian J Surg. 2021 Jan;44(1):313-320. doi: 10.1016/j.asjsur.2020.07.021. Epub 2020 Sep 21.
- Background: PubMed 34593463Lapshyn H, Schulte T, Petruch N, Petrova E, Honselmann K, Deichmann S, Braun R, Kulemann B, Hoeppner J, Rades D, Keck T, Wellner UF, Bausch D, Bolm L. Postoperative Outcomes of Tangential versus Segmental Resection and End-to-end Reconstruction of the Superior Mesenterico-Portal Vein During Pancreatoduodenectomy for Pancreatic Adenocarcinoma: A Single-Center Experience. Anticancer Res. 2021 Oct;41(10):5123-5130. doi: 10.21873/anticanres.15329.
- Background: PubMed 24560302Yu XZ, Li J, Fu DL, Di Y, Yang F, Hao SJ, Jin C. Benefit from synchronous portal-superior mesenteric vein resection during pancreaticoduodenectomy for cancer: a meta-analysis. Eur J Surg Oncol. 2014 Apr;40(4):371-8. doi: 10.1016/j.ejso.2014.01.010. Epub 2014 Feb 7.
- Background: PubMed 27919845Tewari M. Significance of pathological positive superior mesenteric/portal venous invasion in pancreatic cancer. Hepatobiliary Pancreat Dis Int. 2016 Dec;15(6):572-578. doi: 10.1016/s1499-3872(16)60156-x.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 16 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Yosef, Master (+201224807616, minamelad1987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 years). 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 NCT06206382, which also lists 5 linked publications.
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 16 Jan 2024.