UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006155 |
|---|---|
| Receipt number | R000007279 |
| Scientific Title | Evaluation of Aboral Pouch Reconstruction After Total Gastrectomy in Patients with Gastric Cancer : A Prospective Randomized Controlled Trial |
| Date of disclosure of the study information | 2011/08/16 |
| Last modified on | 2017/02/17 13:39:10 |
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Basic information
Public title
Evaluation of Aboral Pouch Reconstruction After Total Gastrectomy in Patients with Gastric Cancer : A Prospective Randomized Controlled Trial
Acronym
CCOG1101
Scientific Title
Evaluation of Aboral Pouch Reconstruction After Total Gastrectomy in Patients with Gastric Cancer : A Prospective Randomized Controlled Trial
Scientific Title:Acronym
CCOG1101
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aboral pouch reconstruction is compared with simple Roux-en-Y reconstruction in a randomized controlled trial to identify the optimal reconstruction procedure after total gastrectomy for patients with gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Assessment of Quality of Life after Total Gastrectomy
Key secondary outcomes
Body weight
Nutritional status
Operation time
Blood loss during the operation
Surgical complications
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
| Maneuver |
Interventions/Control_1
A: Roux-en-Y reconstruction
Interventions/Control_2
B: Aboral pouch reconstruction
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
1st inclusion criteria (before surgery)
1) Histologically proven primary gastric adenocarcinoma
2) Candidate for R0 surgery by total gastrectomy for patients with gastric cancer
3) Length of esophageal invasion less than or equal to 3cm with no need for thoracotomy for resection
4) Borrmann type 4 and large (8cm or more in diameter) type 3 excluded
5) Not cancer of the remnant stomach
6) No history of upper abdominal surgery and no history of intestinal resection
7) No prior treatment of chemotherapy or radiation therapy against any other malignancies
8) Age 20 to 80 years old
9) PS (ECOG) of 0 or 1
10) Adequate organ functions for gastrectomy
11) Written informed consent from the patient
2nd inclusion criteria (during surgery)
1) cT1 - cT4a
2) cN0-2 H0 P0 M0
3) R0 resection possible, or R1 resection due only to CY1
4) No need for thoracotomy
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Body mass index more than 28
3) Uncontrollable hypertension or uncontrollable diabetes mellitus
4) Continuous systemic steroid therapy
5) Otherwise considered inadequate for inclusion in this trial by the physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery II
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2250
miyuki.a@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Ito |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
1-1 Kanokoden, Chikuda-ku, Nagoya, Japan
TEL
052-762-6111
Homepage URL
yuichi@aichi-cc.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group (CCOG)
Institute
Department
Personal name
Funding Source
Organization
Chubu Clinical Oncology Group (CCOG)
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
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
| 2011 | Year | 08 | Month | 16 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2011 | Year | 08 | Month | 12 | Day |
Last modified on
| 2017 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007279
