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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045476
Receipt No. R000051917
Scientific Title Postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy in treatment periampullary cancer
Date of disclosure of the study information 2021/09/15
Last modified on 2021/09/15

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Basic information
Public title Postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy in treatment periampullary cancer: morphology and risk factors: A multicenter prospective study
Acronym POPF after PD:morphology and risk factors
Scientific Title Postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy in treatment periampullary cancer
Scientific Title:Acronym 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.
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
Email 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
Email bsvotruongquoc@ump.edu.vn

Sponsor
Institute University of Medicine and Pharmacy at Ho Chi Minh City
General Surgery Department
Institute
Department

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
Email 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
2021 Year 09 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051917

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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