UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029259 |
|---|---|
| Receipt number | R000033438 |
| Scientific Title | Reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein ligation: prospective study |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2024/09/29 09:13:23 |
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Basic information
Public title
Reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein ligation: prospective study
Acronym
Reconstruction of splenic vein after pancreaticoduodenectomy
Scientific Title
Reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein ligation: prospective study
Scientific Title:Acronym
Reconstruction of splenic vein after pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
resectable or borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of splenic vein reconstruction after pancreaticoduodenectomy with splenic vein ligation to prevent bleeding from varices that are sometimes made after this operation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patency of reconstructed splenic vein, the development of varices and splenic hypertrophy rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein resection.
Interventions/Control_2
No reconstruction of splenic vein after pancreaticoduodenectomy with splenic vein resection.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who undergo pancreaticoduodenectomy with splenic vein resection regardless of neoadjuvant chemo(radiation) therapy.
2) Performance status should be 0-1.
3) Patients who understand the explanation of this study.
Key exclusion criteria
1) Patients who has collaterals due to portal vein obstruction before surgery.
2) Patients who was considered inappropriate by doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Takahashi |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Kotoku, Tokyo, Japan
TEL
03-3520-0111
yu.takahashi@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ono |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Kotoku, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
yoshihiro.ono@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital Of JFCR
Institute
Department
Personal name
Funding Source
Organization
The Cancer Institute Hospital Of JFCR
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cancer Institute Hospital Of JFCR
Address
3-8-31 Ariake, Kotoku, Tokyo, Japan
Tel
03-3520-0111
yoshihiro.ono@jfcr.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
がん研有明病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/33160633
Number of participants that the trial has enrolled
41
Results
Splenic vein (SV) pressure was measured in 41 patients. Among them, 24 had no SV drainage (13 patients had occluded SV reconstruction, and 11 had SV ligation without an attempt at reconstruction) and were included for the analysis. Sinistral portal hypertension (SPH) was observed in 16 of 24 patients (67%). Most patients with SV pressure after SV clamping>20 mmHg (12/14 [86%]) or DSVP >10 mmHg (10/11 [91%]) developed SPH.
Results date posted
| 2024 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with pancreatic cancer who underwent PD with PMSC resection and had their SV pressure measured during surgery were included in this retrospective study. Patients who did not have SV pressure measured during surgery and those for whom follow up was inadequate were excluded. Information regarding patients' demographic data, perioperative and postoperative details, and clinicopathologic factors was collected from medical records.
Participant flow
The study protocol was approved by the Institutional Review Board of Cancer Institute Hospital with waived informed consent.
Adverse events
None
Outcome measures
Postoperatively, we examined whether there were any signs of left-sided portal hypertension (such as gastrointestinal varices or gastrointestinal bleeding) in the medium to long term.
It was demonstrated that reconstruction of the splenic vein can be safely performed to prevent left-sided portal hypertension. Additionally, measuring splenic vein pressure allows for the prediction of future left-sided portal pressure and provides valuable guidance in determining whether splenic vein reconstruction should be performed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033438
