UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042500
Receipt number R000048513
Scientific Title An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy: a prospective observational study
Date of disclosure of the study information 2020/11/19
Last modified on 2020/11/19 15:00:34

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Basic information

Public title

An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy: a prospective observational study

Acronym

An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy

Scientific Title

An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy: a prospective observational study

Scientific Title:Acronym

An invaginated pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy

Region

Japan


Condition

Condition

periampullary tumor

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To describe our pancreaticogastrostomy technique following subtotal stomach-preserving pancreaticoduodenectomy and evaluate the perioperative outcomes with a focus on the incidence of postoperative pancreatic fistula and delayed gastric emptying.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

Clinical relevant pancreatic fistula, delayed gastric emptying, and postoperative complications

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

43 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Pancreaticogastrostomy following subtotal stomach-preserving pancreaticoduodenectomy

Key exclusion criteria

Laparoscopic pancreaticoduodenectomy, pancreaticoduodenectomy, pancreaticojejunostomy

Target sample size

72


Research contact person

Name of lead principal investigator

1st name Teruo
Middle name
Last name Komokata

Organization

National Hospital Organization Kagoshima Medical Center

Division name

Surgery

Zip code

892-0853

Address

8-1 Shiroyama-cho, Kagoshima-city

TEL

099-223-1151

Email

komokata.teruo.je@mail.hosp.go.jp


Public contact

Name of contact person

1st name Teruo
Middle name
Last name Komokata

Organization

National Hospital Organization Kagoshima Medical Center

Division name

Surgery

Zip code

892-0853

Address

8-1 Shiroyama-cho, Kagoshima-city

TEL

099-223-1151

Homepage URL


Email

komokata.teruo.je@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Kagoshima Medical Center

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Kagoshima Medical Center

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

National Hospital Organization Kagoshima Medical Center

Address

8-1 Shiroyama-cho, Kagoshima-city

Tel

099-223-1151

Email

komokata.teruo.je@mail.hosp.go.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 11 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

72

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

Completed

Date of protocol fixation

2013 Year 08 Month 01 Day

Date of IRB

2020 Year 06 Month 04 Day

Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2020 Year 11 Month 19 Day

Last modified on

2020 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048513


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name