UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045487 |
|---|---|
| Receipt number | R000051900 |
| Scientific Title | Occurrence of portomesenteric vein thrombosis in patients undergoing surgery for inflammatory bowel disease |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2022/01/01 16:31:56 |
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Basic information
Public title
Occurrence of portomesenteric vein thrombosis in patients undergoing surgery for inflammatory bowel disease
Acronym
PMVT Study
Scientific Title
Occurrence of portomesenteric vein thrombosis in patients undergoing surgery for inflammatory bowel disease
Scientific Title:Acronym
PMVT Study
Region
| Japan |
Condition
Condition
Crohn's disease, Ulcerative colitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the clinical course of portomesenteric vein thrombosis (PMVT) after surgery for Crohn's disease and ulcerative colitis, including the incidence of PMVT, risk factors, and the need for treatment when it occurs. If these are clarified, the usefulness of postoperative abdominal enhanced CT scan as a screening tool for PMVT can be discussed. If we can identify high risk patients for PMVT, we can optimize screening, and if we know that it can occur in any patient, we can justify the need for screening in all patients. The establishment of a screening method for postoperative PMVT is expected to lead to a favorable postoperative course through early diagnosis and treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of PMVT by enhanced CT taken on postoperative day 7
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study will include the following cases.
(a) Patients for whom information will be collected prospectively after enrollment
(b) Patients for whom previous information will be collected.
(a) Patients for whom information will be collected prospectively after enrollment
(1) Age 20 years or older
(2) Diagnosis confirmed Crohn's disease or ulcerative colitis and scheduled operation for bowel resection regardless of the surgical procedure or approach method (open or laparoscopy).
(3) An abdominal enhanced computed tomography (CT) scan was performed within 4 weeks prior to surgery and no portomesenteric vein thrombosis was noted.
(b)Patients for whom previous information will be collected
(1) Age 20 years old or older
(2) Patients who were diagnosed with ulcerative colitis and underwent bowel resection regardless of the surgical procedure or approach method (open or laparoscopy) between January 1, 2015 and October 31, 2021
(3) Patients who were diagnosed with Crohn's disease and underwent bowel resection regardless of the surgical procedure or approach method (open or laparoscopy) between January 1, 2020 and October 31, 2021
(4) An abdominal enhanced CT scan was performed within 4 weeks prior to surgery and no portomesenteric vein thrombosis was noted.
(5) An abdominal enhanced CT scan was performed on the postoperative day 7
Key exclusion criteria
(1) Patients who cannot undergo postoperative follow-up with abdominal enhanced CT scan due to decreased renal function, contrast media-induced allergy, etc.
(2) Not appropriate for the study at the physician's assessment
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Goro |
| Middle name | |
| Last name | Nakayama |
Organization
Nagoya University Hospital
Division name
IBD Center
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
0527442250
goro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Norifumi |
| Middle name | |
| Last name | Hattori |
Organization
Nagoya University Hospital
Division name
Department of Gastoroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
0527442250
Homepage URL
norifumi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Certified Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Tel
0527442243
ethics@med.nagoya-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Secondary outcomes: incidence of pouchitis, treatment course of additional treatment including anticoagulation therapy, length of hospital stay, and recurrence rate of portomesenteric vein thrombosis after completion of anticoagulation therapy
Management information
Registered date
| 2021 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051900
