UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Aboral Pouch Reconstruction After Total Gastrectomy in Patients with Gastric Cancer : A Prospective Randomized Controlled Trial
Title of the study (Brief title)	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	Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Surgery II
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2250
Email	miyuki.a@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yuichi Ito
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastroenterological Surgery
Address	1-1 Kanokoden, Chikuda-ku, Nagoya, Japan
TEL	052-762-6111
Homepage URL
Email	yuichi@aichi-cc.jp

Sponsor
Institute	Chubu Clinical Oncology Group (CCOG)
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007279