UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019125 |
|---|---|
| Receipt number | R000017068 |
| Scientific Title | Pulmonary thrombosis after digestive surgical operation =Prospective observational study of diagnosis rate of pulmonary thrombosis with multi detector row CT and perfusion SPECT, incidence of deep vein thrombosis and potentialities of endothelial function test as preoperative predictive factor for postoperative pulmonary thrombosis= |
| Date of disclosure of the study information | 2015/09/27 |
| Last modified on | 2019/04/14 17:05:16 |
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Basic information
Public title
Pulmonary thrombosis after digestive surgical operation
=Prospective observational study of diagnosis rate of pulmonary thrombosis with multi detector row CT and perfusion SPECT, incidence of deep vein thrombosis and potentialities of endothelial function test as preoperative predictive factor for postoperative pulmonary thrombosis=
Acronym
Prospective observational study of pulmonary thrombosis after digestive surgical operation
Scientific Title
Pulmonary thrombosis after digestive surgical operation
=Prospective observational study of diagnosis rate of pulmonary thrombosis with multi detector row CT and perfusion SPECT, incidence of deep vein thrombosis and potentialities of endothelial function test as preoperative predictive factor for postoperative pulmonary thrombosis=
Scientific Title:Acronym
Prospective observational study of pulmonary thrombosis after digestive surgical operation
Region
| Japan |
Condition
Condition
pulmonary thrombosis after digestive surgical operation
Classification by specialty
| Cardiology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Radiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to clarify a difference in diagnosis rate of pulmonary thrombosis after digestive surgical operation between multi detector row CT and perfusion SPECT.
The secondary objective of this study is to identify incidence of deep vein thrombosis in patients with postoperative pulmonary thrombosis and potentialities of endothelial function test as preoperative predictive factor for postoperative pulmonary thrombosis. Furthermore, we will survey prognosis of patients with postoperative pulmonary thrombosis for two years.
Basic objectives2
Others
Basic objectives -Others
Prospective comparison in diagnosis rate
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in diagnosis rate of pulmonary thrombosis after digestive surgical operation between multi detector row CT and perfusion SPECT
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
The patient that elective digestive surgical operation under general anesthesia is planned in Shinbeppu hospital.
Key exclusion criteria
(1) emergency operation, (2) age < 20 years, (3) eGFR < 30ml/min/1.73m2, (4) pregnancy and possibility of pregnancy, (5) drug abuse and alcoholism, (6) critical illness, (7) shock or hypotension, (8) positive for preoperative VTE, (9) use of anticoagulants, (10) patients whose lower extremity is paralyzed for stroke or head injury, (11) refusal to provide informed consent, (12) patient judged not eligible for subject by principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Okuyama |
Organization
Shinbeppu Hospital
Division name
Divisions of Cardiovascular Medicine
Zip code
874-0833
Address
3898 Oaza Tsurumi, Beppu, Oita 874-0833, Japan
TEL
+81-977-22-0391
eokuyama@shinbeppu-hosp.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Isozaki |
Organization
Shinbeppu Hospital
Division name
General Affairs Division
Zip code
874-0833
Address
3898 Oaza Tsurumi, Beppu, Oita 874-0833, Japan
TEL
+81-977-22-0391
Homepage URL
irb@shinbeppu-hosp.jp
Sponsor or person
Institute
Shinbeppu 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
Ethics Review Board of Shinbeppu Hospital
Address
3898 Oaza Tsurumi, Beppu, Oita 874-0833, Japan
Tel
+81-977-22-0391
irb@shinbeppu-hosp.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
新別府病院 (大分県) Shinbeppu Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
in submission
Publication of results
Unpublished
Result
URL related to results and publications
in submission
Number of participants that the trial has enrolled
Results
The postoperative PT detection rate was significantly higher for Q scan than for CTA, suggesting that postoperative PT occurs due to a mechanism other than DVT-borne thrombosis. The preoperative EndoPAT values were low in patients diagnosed with postoperative PT on CTA and in those diagnosed with postoperative PT on Q scan planar images; however, these differences were not significant. No PT-related deaths were noted.
Results date posted
| 2019 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
mean age: 70.6 years; males: 22 (64.7%); malignant disease: 27 patients (79.4%); mean body mass index (BMI): 24.2; laparoscopic surgery: 11 patients (32.4%); open surgery: 23 patients (67.6%); mean operation time: 4.2 h; and outcomes of 2-year postoperative prognosis: survival in 30 patients (88.2%), death due to cancer in 3 (8.8%), and cerebral hemorrhage in 1 (2.9%)
Participant flow
Patients aged >20 years who met the inclusion criteria were screened for eligibility. Patients who planned to undergo elective surgery (laparoscopic or open surgery under general anesthesia) at the Department of Gastrointestinal Surgery, Shinbeppu Hospital were included.
Adverse events
none
Outcome measures
The postoperative PT detection rate for each modality (CTA and Q scan) was the primary endpoint. The secondary endpoints were as follows: DVT complication rate in postoperative PT patients, differences between endothelial function assessed by EndoPAT in the postoperative PT and no postoperative PT groups, and 2-year postoperative prognosis (all-cause mortality).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study design: cohort study
Study Population
Patients that elective digestive surgical operation under general anesthesia are planned in Shinbeppu hospital between September 1, 2014, and August 31, 2016 are eligible for enrollment if they meet the inclusion criteria.
OUTCOMES
The primary outcome is verification of a difference in diagnosis rate of pulmonary thrombosis after digestive surgical operation between multi detector row CT and perfusion SPECT.
The secondary outcome include incidence of deep vein thrombosis, endothelial function using the Endo-PAT 2000 device (Itamar Medical Inc, Caesarea, Israel), and surveillance of patients with postoperative pulmonary thrombosis for two years.
Management information
Registered date
| 2015 | Year | 09 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017068
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