Ductal Adenocarcinoma of the PancreasNCT06119776
Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study
An observational study of Ductal Adenocarcinoma of the Pancreas, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ductal Adenocarcinoma of the Pancreas
- What is being tested?
- Whipple over the splenic artery and Total pancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2020to 20 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pancreatic ductal cell adenocarcinoma (PDCA) patients
Who may be able to join
- pancreatic ductal cell adenocarcinoma (PDCA) patients
Who cannot join
- Patient undergoing palliative pancreatectomy, other malignancies with distant metastases
- Vulnerable groups
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ting-Chung Kuo, +88623123456 ext. 62557, tinakuo1204@gmail.com
About this study
Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).
Read the detailed description
Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).
Methods: The study group comprised 40 consecutive patients who underwent WOTSA for PDAC. Their clinicopathological characteristics and survival were compared with those of a historical control group comprising 30 consecutive patients who underwent TP between.
- Conditions
- Ductal Adenocarcinoma of the Pancreas
- Being tested
- Whipple over the splenic artery, Total pancreatectomy
- Keywords
- Ductal Adenocarcinoma, Pancreatectomies, Whipple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whipple over the splenic arteryProcedure or surgery
Treatment for pancreatic ductal cell adenocarcinoma
Total pancreatectomyProcedure or surgery
Treatment for pancreatic ductal cell adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| Study | Patients who underwent Whipple over the splenic artery (WOTSA) as a treatment for PDAC Receives: Procedure: Whipple over the splenic artery | |
| Control | Patients who underwent total pancreatectomy (TP) as a treatment for PDAC Receives: Procedure: Total pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicopathological characteristics
Measurement of the remnant pancreatic volume
Measured: before
Clinicopathological characteristics
Measurement of the remnant pancreatic volume
Measured: 1 week after the operation
Secondary outcomes (1)
Postoperative chemotherapy and follow-up
Measurement of the remnant pancreatic volume and physiological parameters
Measured: 1 month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start20 May 2020
- Primary completion20 May 2020
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119776
- Sponsor's protocol ID
- 202004002RINA
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study
- ClinicalTrials.gov ID
- NCT06119776
- Acronym / sponsor ID
- 202004002RINA
- Conditions
- Ductal Adenocarcinoma of the Pancreas
- Keywords
- Ductal Adenocarcinoma, Pancreatectomies, Whipple
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 7 Nov 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.
Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).
Detailed description
Recently, more and more total pancreatectomy (TP) has been performed for pancreatic ductal cell adenocarcinoma (PDCA) which abuts or involves both gastroduodenal and splenic arteries. Warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. Likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during Whipple (WOTSA). In that case, TP can be replaced by WOTSA. This uncontrolled before and after study assesses the safety and efficacy of a new technique "Whipple over the splenic artery (WOTSA)" as a treatment for PDAC which traditionally requires total pancreatectomy (TP).
Methods: The study group comprised 40 consecutive patients who underwent WOTSA for PDAC. Their clinicopathological characteristics and survival were compared with those of a historical control group comprising 30 consecutive patients who underwent TP between.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Procedure: Whipple over the splenic arteryPatients who underwent Whipple over the splenic artery (WOTSA) as a treatment for PDAC |
| Control | – | Procedure: Total pancreatectomyPatients who underwent total pancreatectomy (TP) as a treatment for PDAC |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pancreatic ductal cell adenocarcinoma (PDCA) patients
Key inclusion criteria (1 listed)
- pancreatic ductal cell adenocarcinoma (PDCA) patients
Key exclusion criteria (2 listed)
- Patient undergoing palliative pancreatectomy, other malignancies with distant metastases
- Vulnerable groups
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 over the splenic arteryTreatment for pancreatic ductal cell adenocarcinoma | Procedure or surgery | Study |
| Total pancreatectomyTreatment for pancreatic ductal cell adenocarcinoma | Procedure or surgery | Control |
Primary outcome
Clinicopathological characteristics
Time frame: before
Measurement of the remnant pancreatic volume
Clinicopathological characteristics
Time frame: 1 week after the operation
Measurement of the remnant pancreatic volume
1 secondary outcome
Postoperative chemotherapy and follow-up
Time frame: 1 month after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Ductal Adenocarcinoma of the Pancreas, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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 7 Nov 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-Chun Kuo (+88623123456 ext. 62557, tinakuo1204@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinicopathological characteristics (time frame: before). 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 7 Nov 2023.