UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023464
Receipt number R000026965
Scientific Title A randomized phaseII study to evaluate quality of life after total gastrectomy using a linear stapler vs a circular stapler for esophagojejunostomy
Date of disclosure of the study information 2016/08/03
Last modified on 2024/03/04 11:21:38

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A randomized phaseII study to evaluate quality of life after total gastrectomy using a linear stapler vs a circular stapler for esophagojejunostomy

Acronym

Laparoscopic esophagojejunostomy with linear or circular stapler

Scientific Title

A randomized phaseII study to evaluate quality of life after total gastrectomy using a linear stapler vs a circular stapler for esophagojejunostomy

Scientific Title:Acronym

Laparoscopic esophagojejunostomy with linear or circular stapler

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the superiority of the linear stapler compared with the circular stapler for esophagojejunostomy after total gastrectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Postgastrectomy syndrome at 12 months after operation (Complaint will be evaluated by EORTC QLQ-STO22)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Esophagojejunostomy is performed using a linear stapler.

Interventions/Control_2

Esophagojejunostomy is performed using a circular stapler.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histologically proven adenocarcinoma of the stomach
2. A total gastrectomy with curative intention is planned for gastric cancer located in the upper third of the stomach.
3. cStage I-III
4. No esophageal invasion
5. No gastric stump cancer
6. Sufficient oral intake, and continuous transfusion is not necessary
7. Simultaneous resection of organs other than the gallbladder and spleen is not planned.
8. Over 20 years old
9. Eastern clinical oncology group performance status is 0 or 1.
10. No previous chemotherapy or radiation therapy, including those for other cancers
11. Body mass index is less than 30.
12. Fulfills all of the following conditions
WBC>3,000/mm3
Plt>100,000/mm3
AST<100IU/L
ALT<100IU/L
T.Bil<2.0g.dl
Cre<1.5mg/dl
13. Written informed consent

Key exclusion criteria

1. Other active cancer
2. Active infectious disease
3. Possibly pregnant, or breast feeding woman
4. Psychiatric disorder
5. Receiving steroids
6. Acute myocardial infarction within 6 months or unstable angina
7. Uncontrolled hypertension
8. Uncontrolled diabetes mellitus and receiving insulin treatment
9. Pulmonary disease requiring continuous oxygen therapy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Masanori
Middle name
Last name Terashima

Organization

Shizuoka Cancer Center

Division name

Gastric Surgery

Zip code

411-8777

Address

1007,Shimonagakubo, Nagaizumi, Sunto, Shizuoka

TEL

055-989-5222

Email

m.terashima@scchr.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Koseki

Organization

Shizuoka Cancer Center

Division name

Gastric Surgery

Zip code

411-8777

Address

1007,Shimonagakubo, Nagaizumi, Sunto, Shizuoka

TEL

055-989-5222

Homepage URL


Email

y.koseki@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Shizuoka Cancer Center

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

Shizuoka Cancer Center

Address

1007,Shimonagakubo, Nagaizumi, Sunto, Shizuoka

Tel

055-989-5222

Email

rinsho_office@scchr.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

2016 Year 08 Month 03 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


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

Enrolling by invitation

Date of protocol fixation

2015 Year 05 Month 26 Day

Date of IRB

2015 Year 08 Month 25 Day

Anticipated trial start date

2016 Year 08 Month 08 Day

Last follow-up date

2027 Year 08 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 03 Day

Last modified on

2024 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026965


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name