Pancreas CancerWATSANCT01155882
Registry Study - Whipple at the Splenic Artery
An observational study of Pancreas Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Whipple at the Splenic Artery (WATSA)
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2010to 16 Jan 2019
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be identified from PI's patient population or referrals from colleagues.
Eligibility Criteria - Prospective Portion:
- Patient must have diagnosis of ductal adenocarcinoma of head and/or neck of pancreas, ampullary adenocarcinoma, or pancreatic neuroendocrine tumor confirmed by tissue diagnosis.
- Patient must be between 18 to 85 years of age.
- Patient must be a candidate for the WATSA procedure or have had the WATSA surgery performed within 1 year.
- Patient must be able to understand and willing to sign a written informed consent document.
Eligibility Criteria - Retrospective Portion:
Patient underwent WATSA procedure at our institution between 01/01/2009 and 12/31/2011.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Whipple at the Splenic Artery - A Procedure for Ductal Adenocarcinoma of the Pancreas With Extensive Involvement of the Porto-Mesenteric Axis: A Registry Study
The purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA).
Read the detailed description
Primary
The primary objective of this registry study is to collect clinical data from patients who undergo the WATSA procedure. Specific hypotheses to be tested are
- To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
- To determine if WATSA can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.
Secondary
The secondary objectives of this registry study are to
- To determine the survival/recurrence rates at 2 years.
- To determine the effect of occlusion of the splenic vein at the confluence.
- Conditions
- Pancreas Cancer
- Being tested
- Whipple at the Splenic Artery (WATSA)
- 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 at the Splenic Artery (WATSA)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Whipple Surgery at the Splenic Artery | Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins. Receives: Procedure: Whipple at the Splenic Artery (WATSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectivity of the Whipple at the Splenic Artery
To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
Measured: By CT scan at 8 weeks post surgery
To determine range of morbidity and mortality
To determine if Whipple at the splenic artery can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.
Measured: 30 day postoperative mortality
Secondary outcomes (2)
Survival/recurrence at 2 years
To determine the survival/recurrence rates at 2 years.
Measured: 2 years
Effect of occlusion of the splenic vein at the confluence.
To determine the effect of occlusion of the splenic vein at the confluence.
Measured: By CT scan at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study start20 Sep 2010
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Strasberg, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155882
- Sponsor's protocol ID
- 10-0767 / 201105335
- Acronym
- WATSA
- Status last verified
- Jan 2019
- First submitted
- 30 Jun 2010
- Last updated
- 22 Jan 2019
- 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 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whipple at the Splenic Artery - A Procedure for Ductal Adenocarcinoma of the Pancreas With Extensive Involvement of the Porto-Mesenteric Axis: A Registry Study
- ClinicalTrials.gov ID
- NCT01155882
- Acronym / sponsor ID
- WATSA / 10-0767 / 201105335
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 20 Sep 2010 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 2 Jul 2010 (estimated)
- 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 purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA).
Detailed description
Primary
The primary objective of this registry study is to collect clinical data from patients who undergo the WATSA procedure. Specific hypotheses to be tested are
- To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
- To determine if WATSA can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.
Secondary
The secondary objectives of this registry study are to
- To determine the survival/recurrence rates at 2 years.
- To determine the effect of occlusion of the splenic vein at the confluence.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whipple Surgery at the Splenic Artery | – | Procedure: Whipple at the Splenic Artery (WATSA)Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified from PI's patient population or referrals from colleagues.
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 at the Splenic Artery (WATSA) | Procedure or surgery | Whipple Surgery at the Splenic Artery |
Primary outcome
Effectivity of the Whipple at the Splenic Artery
Time frame: By CT scan at 8 weeks post surgery
To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
To determine range of morbidity and mortality
Time frame: 30 day postoperative mortality
To determine if Whipple at the splenic artery can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.
2 secondary outcomes
Survival/recurrence at 2 years
Time frame: 2 years
Effect of occlusion of the splenic vein at the confluence.
Time frame: By CT scan at 8 weeks
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 22 Jan 2019.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Steven Strasberg, M.D. principal investigator
Washington University School of Medicine
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 Pancreas Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Jan 2019. 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 United States. 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?
Effectivity of the Whipple at the Splenic Artery (time frame: By CT scan at 8 weeks post surgery). 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 22 Jan 2019.