UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045476 |
|---|---|
| Receipt number | R000051917 |
| Scientific Title | Clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy in treatment periampullary cancer |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2023/03/17 23:46:27 |
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Basic information
Public title
Clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy in treatment periampullary cancer: morphology and risk factors: A multicenter prospective study
Acronym
CR-POPF after PD:morphology and risk factors
Scientific Title
Clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy in treatment periampullary cancer
Scientific Title:Acronym
CR-POPF after PD
Region
| Asia(except Japan) |
Condition
Condition
Periampullary cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Periampullary cancer
Basic objectives2
Others
Basic objectives -Others
Patients with periampullary cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pancreatic fistula (POPF)
Time: we will measure abdominal fluid's amylase on postoperative day 3rd to determine whether there is POPF.
We follow within 90 days after pancreaticoduodenectomy
Key secondary outcomes
Risk factors relating to postoperative pancreatic fistula
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with periampullary cancer and:
- Postoperative pathology is carcinoma of pancreas, duodenum, biliary duct, ampulla Vater.
- Possibility of pancreaticoduodenectomy
Key exclusion criteria
The patients who do not agree to participate in the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Vo |
| Middle name | Truong |
| Last name | Quoc |
Organization
University of Medicine and Pharmacy at Ho Chi Minh City
Division name
UMP
Zip code
700000
Address
230/12/12 Phan Huy Ich Street, Ward 12, District Go Vap, Hochiminh City, Vietnam
TEL
084364662378
bsvotruongquoc@ump.edu.vn
Public contact
Name of contact person
| 1st name | Vo |
| Middle name | Truong |
| Last name | Quoc |
Organization
University of Medicine and Pharmacy at Ho Chi Minh City
Division name
UMP
Zip code
700000
Address
230/12/12 Phan Huy Ich Street, Ward 12, District Go Vap, Hochiminh City, Vietnam
TEL
084364662378
Homepage URL
bsvotruongquoc@ump.edu.vn
Sponsor or person
Institute
University of Medicine and Pharmacy at Ho Chi Minh City
General Surgery Department
Institute
Department
Personal name
Funding Source
Organization
University of Medicine and Pharmacy at Ho Chi Minh City
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Vietnam
Other related organizations
Co-sponsor
Cho Ray Hospital
Name of secondary funder(s)
Medicine and Pharmacy Center
IRB Contact (For public release)
Organization
University of Medicine and Pharmacy at Ho Chi Minh City
Address
217 Hong Bang Street, District 5, Ward 11, Ho Chi Minh City, Vietnam
Tel
084283855 8411
daihocyduoc@ump.edu.vn
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
University of Medicine and Pharmacy (Ho Chi Minh City)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 15 | 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
150
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Patient with periampullary cancer
Adverse events
Outcome measures
Postoperative pancreatic fistula
Plan to share IPD
The data will be share right after finishing the process of data collecting
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
The investigator will collect preoperative information of the patient with periampullary cancer who taking part in the study. The patient will be performed pancreaticoduodenectomy. The investigator will follow up the postoperative period and investigate POPF cases
Management information
Registered date
| 2021 | Year | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051917
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