- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06119776
Most Total Pancreatectomies for Ductal Adenocarcinoma Can Be Replaced by Whipple Over the Splenic Artery: A Before and After Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ting-Chun Kuo
- Phone Number: 62557 +88623123456
- Email: tinakuo1204@gmail.com
Study Locations
-
-
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Ting-Chung Kuo
- Phone Number: 62557 +88623123456
- Email: tinakuo1204@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- pancreatic ductal cell adenocarcinoma (PDCA) patients
Exclusion Criteria:
- Patient undergoing palliative pancreatectomy, other malignancies with distant metastases
- Vulnerable groups
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study
Patients who underwent Whipple over the splenic artery (WOTSA) as a treatment for PDAC
|
Treatment for pancreatic ductal cell adenocarcinoma
|
Control
Patients who underwent total pancreatectomy (TP) as a treatment for PDAC
|
Treatment for pancreatic ductal cell adenocarcinoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinicopathological characteristics
Time Frame: before
|
Measurement of the remnant pancreatic volume
|
before
|
Clinicopathological characteristics
Time Frame: 1 week after the operation
|
Measurement of the remnant pancreatic volume
|
1 week after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative chemotherapy and follow-up
Time Frame: 1 month after the operation
|
Measurement of the remnant pancreatic volume and physiological parameters
|
1 month after the operation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 1 day before the operation
|
Measurement of the physiological parameters
|
1 day before the operation
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 3 months after the operation
|
Measurement of the physiological parameters
|
3 months after the operation
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 months after the operation
|
Measurement of the physiological parameters
|
6 months after the operation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202004002RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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