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Recruitment status Completed
Unique ID issued by UMIN UMIN000002116
Receipt No. R000002578
Scientific Title A study to observe correlation between resection and reconstruction procedures employed for gastric neoplasms and development of postgastrectomy syndrome
Date of disclosure of the study information 2009/06/25
Last modified on 2017/08/08

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Basic information
Public title A study to observe correlation between resection and reconstruction procedures employed for gastric neoplasms and development of postgastrectomy syndrome
Acronym A study to observe correlation between resection and reconstruction procedures employed for gastric neoplasms and development of postgastrectomy syndrome
Scientific Title A study to observe correlation between resection and reconstruction procedures employed for gastric neoplasms and development of postgastrectomy syndrome
Scientific Title:Acronym A study to observe correlation between resection and reconstruction procedures employed for gastric neoplasms and development of postgastrectomy syndrome
Region
Japan

Condition
Condition Gastric cancer patients who underwent various types of gastrectomy
(GIST patients who underwent gastric wedge resection are also included)
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine health related quality of life and degree of postgastrectomy syndrome among patients who underwent various types of gastrectomy and reconstruction procedures.
Basic objectives2 Others
Basic objectives -Others To study usefulness and validity of a questionnaire, which has been developed by a nationwide study group to assess health related quality of life and degree of postgastrectomy syndrome among patients who underwent surgery for gastric neoplasms.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To examine the degree of generic QOL (SF-8), symptom specific QOL (GSRS), other abdominal symptoms, ingested amount, weight loss and satisfaction.
Key secondary outcomes To investigate the correlation between above mentioned factors.

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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria The inclusion criteria are as follows:
(1) Gastric cancer patients with pathologically confirmed stage IA or IB disease or patients with a GIST who underwent gastric wedge resection.
(2) Patients who underwent gastrectomy for the first time.
(3) Patients who were not treated with chemotherapy.
(4) Patients without any recurrence or distant metastasis.
(5) Patients with an interval of one year or longer after gastrectomy.
(6) Physical status 0 or 1.
(7) Fully capable of understanding and responding to the questionnaire.
(8) Without any other disease or previous surgery which may influence the results of questionnaire more than gastrectomy.
(9) Without any organ failure or mental disease.
(10) Written informed consent with date and signature of the said person.
Key exclusion criteria (1) Active dual malignancy.
(2) Patients who underwent concomitant resection of other organ(s) due to another disease (co-resection equivalent to cholecystectomy being the exceptions).
(3) Considered as unsuitable to participate in the study by a surgeon who is in charge.
Target sample size 5600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Nakada
Organization The Jikei University School of Medicine
Division name Department of Surgery
Zip code
Address 3-25-8, nishishimbashi, minato-ku, Tokyo, 105-8461 Japan
TEL 03-3433-1111
Email nakada@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Nakada
Organization The Jikei University School of Medicine
Division name Department of Surgery
Zip code
Address 3-25-8, nishishimbashi, minato-ku, Tokyo, 105-8461 Japan
TEL 03-3433-1111
Homepage URL
Email nakada@jikei.ac.jp

Sponsor
Institute Department of Surgery, The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Japanese Society for Gastro-surgical Pathophysiology

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 静岡県立静岡がんセンター(静岡県)、市立豊中病院(大阪府)、広島大学病院(広島県)、千葉県がんセンター(千葉県)、横浜市立市民病院(神奈川県)、愛知県がんセンター中央病院(愛知県)、東京慈恵会医科大学病院(東京都)、千葉大学病院(千葉県)、高知大学病院(高知県)、栃木県立がんセンター(栃木県)京都大学病院(京都府) 、県立広島病院(広島県)、埼玉県立がんセンター(埼玉県)、山形県立中央病院(山形県)、名古屋大学病院(愛知県)、大阪厚生年金病院(大阪府)、川崎医科大学病院(岡山県)、函館五稜郭病院(北海道)、横浜市立大学附属市民総合医療センター(神奈川県)、帝京大学病院(東京都)、新潟県立がんセンター新潟病院(新潟県)、東京女子医科大学病院(東京都)、がん研有明病院(東京都)、岩手医科大学病院(岩手県)、JA廣島総合病院(広島県)、東邦大学医療センター大橋病院(東京都)、岐阜市民病院(岐阜県)、大阪医科大学病院(大阪府)、福岡大学病院(福岡県)、神戸市立医療センター中央市民病院(兵庫県)、佐久市立国保浅間総合病院(長野県)、筑波大学病院(茨城県)、北野病院(大阪府)、札幌医科大学病院(北海道)、浜松医科大学病院(静岡県)、がん・感染症センター都立駒込病院(東京都)、原町赤十字病院(群馬県)、九州大学病院(福岡県)、鹿児島大学病院(鹿児島県)、金沢医科大学病院(石川県)、長崎医療センター(長崎県)、国際医療福祉大学三田病院(東京都)、久留米大学病院(福岡県)、大阪府済生会野江病院(大阪府)、京都医療センター(京都府)、大手前病院(大阪府)、東京女子医科大学東医療センター(東京都)、東京慈恵会医科大学柏病院(千葉県)、城山病院(大阪府)、大分大学病院(大分県)、東北大学病院(宮城県)、横須賀市立うわまち病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 25 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
1. Nakada K, et al. Characteristics and clinical relevance of postgastrectomy syndrome assessment scale (PGSAS)-45: newly developed integrated questionnaires for assessment of living status and quality of life in postgastrectomy patients. 
Gastric Cancer. 2015 Jan;18(1):147-58.

2. Terashima M, et al. Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 and Changes in Body Weight are Useful Tools for Evaluation of Reconstruction Methods Following Distal Gastrectomy. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S370-8. 

3. Namikawa T, et al. Factors that minimize postgastrectomy symptoms following pylorus-preserving gastrectomy: assessment using a newly developed scale (PGSAS-45). Gastric Cancer.  2015 Apr;18(2):397-406.

4. Takiguchi N, et al. Long-term quality-of-life comparison of total gastrectomy and proximal gastrectomy by Postgastrectomy Syndrome Assessment Scale (PGSAS-45): a nationwide multi-institutional study. Gastric Cancer. 2015 Apr;18(2):407-16. 

5. Misawa K, et al. Evaluation of postgastrectomy symptoms after distal gastrectomy with Billroth-I reconstruction using the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45). Gastric Cancer. 2015 Jul;18(3):675-81.

6. Inada T, et al. Evaluation of QOL After Proximal Gastrectomy Using a Newly Developed Assessment Scale (PGSAS-45). World J Surg. 2014 Dec;38(12):3152-62. 

7.  Kawahira H, et al. Optimal Roux-en-Y reconstruction after distal gastrectomy for early gastric cancer as assessed using the newly developed PGSAS-45 scale.
Surg Today. 2015 Oct;45(10):1307-16.

8.  Fujita J, et al. Assessment of postoperative quality of life following pylorus-preserving gastrectomy and Billroth-I distal gastrectomy in gastric cancer patients: results of the nationwide postgastrectomy syndrome assessment study.
Gastric Cancer 2016 Jan; 19(1): 302-311.
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
2009 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2012 Year 02 Month 01 Day

Other
Other related information To compare the degree of postgastrectomy syndrome and the health related quality of life among patients who underwent various types of gastrectomy and reconstruction procedures.

Management information
Registered date
2009 Year 06 Month 24 Day
Last modified on
2017 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002578

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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