UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010719
Receipt number R000012399
Scientific Title Prospective randomized trial comparing boomerang-shaped jejunal interposition and Billroth-I reconstruction after distal gastrectomy for gastric cancer: clinical outcomes and long-term quality of life
Date of disclosure of the study information 2013/05/14
Last modified on 2015/05/18 11:19:35

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Basic information

Public title

Prospective randomized trial comparing boomerang-shaped jejunal interposition and Billroth-I reconstruction after distal gastrectomy for gastric cancer: clinical outcomes and long-term quality of life

Acronym

Long-term comparison of boomerang-shaped jejunal interposition and Billroth-I reconstruction

Scientific Title

Prospective randomized trial comparing boomerang-shaped jejunal interposition and Billroth-I reconstruction after distal gastrectomy for gastric cancer: clinical outcomes and long-term quality of life

Scientific Title:Acronym

Long-term comparison of boomerang-shaped jejunal interposition and Billroth-I reconstruction

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The Billroth-I reconstruction procedure is a simple, physiological method of reconstruction following distal gastrectomy. Although jejunal pouch interposition is performed to improve postoperative quality of life, it is often accompanied by pronounced gastric stasis. The purpose of this study was to assess the safety and efficacy of boomerang-shaped jejunal interposition.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

endoscopic findings (every 12 months after surgery)

Key secondary outcomes

1) operative time and blood loss
2) postoperative complications
3) postoperative clinical symptoms
4) meal size and number of meals
5) body weight(every 12 months after surgery)
6)24-h bilirubin monitoring


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Distal gastrectomy... Boomerang-shaped jejunal interposition... All subjects are to be followed up for 5 years via regular outpatient visits

Interventions/Control_2

Distal gastrectomy... Billroth-I reconstruction... All subjects are to be followed up for 5 years via regular outpatient visits

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

curable gastric cancer patients

Key exclusion criteria

1) Performance status (ECOG) >=2
2) multiple cancer patient

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Kato

Organization

Dokkyo Medical University

Division name

Surgery 1 (Department of Surgical Oncology)

Zip code


Address

Kitakobayashi 880, Mibu, Tochigi, Japan

TEL

0282-87-2157

Email

hkato@dokkyomed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kinro Sasaki

Organization

Dokkyo Medical University

Division name

Surgery 1 (Department of Surgical Oncology)

Zip code


Address

Kitakobayashi 880, Mibu, Tochigi, Japan

TEL

0282-87-2157

Homepage URL


Email

k-sasaki@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University, Surgery 1 (Department of Surgical Oncology)

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


Address


Tel


Email



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

2013 Year 05 Month 14 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


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

2000 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2000 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 05 Month 14 Day

Last modified on

2015 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012399


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name