Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study
1 other identifier
observational
70
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2020
CompletedFirst Submitted
Initial submission to the registry
August 22, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2025
CompletedNovember 7, 2023
August 1, 2023
Same day
August 22, 2023
November 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinicopathological characteristics
Measurement of the remnant pancreatic volume
before
Clinicopathological characteristics
Measurement of the remnant pancreatic volume
1 week after the operation
Secondary Outcomes (1)
Postoperative chemotherapy and follow-up
1 month after the operation
Other Outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 day before the operation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
3 months after the operation
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
6 months after the operation
Study Arms (2)
Study
Patients who underwent Whipple over the splenic artery (WOTSA) as a treatment for PDAC
Control
Patients who underwent total pancreatectomy (TP) as a treatment for PDAC
Interventions
Eligibility Criteria
pancreatic ductal cell adenocarcinoma (PDCA) patients
You may qualify if:
- pancreatic ductal cell adenocarcinoma (PDCA) patients
You may not qualify if:
- Patient undergoing palliative pancreatectomy, other malignancies with distant metastases
- Vulnerable groups
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2023
First Posted
November 7, 2023
Study Start
May 20, 2020
Primary Completion
May 20, 2020
Study Completion
May 20, 2025
Last Updated
November 7, 2023
Record last verified: 2023-08