UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040417 |
|---|---|
| Receipt number | R000046109 |
| Scientific Title | The safety of postoperative care without nasogastric tube after pylorus-resectiong pancreaticoduodenectomy |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2023/05/19 19:15:10 |
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Basic information
Public title
The safety of postoperative care without nasogastric tube after pylorus-resecting pancreaticoduodenectomy
Acronym
The safety of no NGT after PrPD
Scientific Title
The safety of postoperative care without nasogastric tube after pylorus-resectiong pancreaticoduodenectomy
Scientific Title:Acronym
The safety of no NGT after PrPD
Region
| Japan |
Condition
Condition
periampullary tumor or inflammatory disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to invastigate the safety of postoperative care without no nasogastric tube after pancreaticoduodenectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of reinsertion of nasogastric tube
Key secondary outcomes
Risk factors of reinsertion of nasogastric tube
Risk factors of delayed gastric emptying
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent pancreaticoduodenectomy from April 2009 to December 2019 at Wakayama Medical University
Key exclusion criteria
1) Patients who refused to be enrolled in this trial
2) Patients who are judged inappropriate by investigators
Target sample size
607
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Miyazawa |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture, Japan
TEL
073-441-0613
mo-0702@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Miyazawa |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture, Japan
TEL
073-441-0613
Homepage URL
mo-0702@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
doi: 10.1016/j.surg.2021.03.059.
Publication of results
Published
Result
URL related to results and publications
doi: 10.1016/j.surg.2021.03.059.
Number of participants that the trial has enrolled
465
Results
The rate of nasogastric tube reinsertion was 10.1% (47/465).
Results date posted
| 2023 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 01 | Day |
Baseline Characteristics
Pancreaticoduodenectomy without subsequent nasogastric tube management has not been widely adopted due to delayed gastric emptying, the specific and frequent morbidity associated with this surgical procedure. We assessed the feasibility of pancreaticoduodenectomy without use of nasogastric tubes and the risk factors for subsequent nasogastric tube reinsertion.
Participant flow
We retrospectively reviewed 465 patients who underwent pancreaticoduodenectomy at a single institution between 2010 and 2019.
Adverse events
none
Outcome measures
Primary endpoint was the rate of nasogastric tube reinsertion. Logistic regression analysis was used to determine independent risk factors of nasogastric tube reinsertion and delayed gastric emptying.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study of analyzing the association between patients characteristics , operative data and the reinsertion of nasogastric tube after pancretaticoduodenectomy
Management information
Registered date
| 2020 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046109
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