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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017553
Receipt No. R000020319
Scientific Title Randomized Clinical Trial to Determine the Optimal Term of Nasogastric Decompression After Esophagectomy
Date of disclosure of the study information 2015/05/25
Last modified on 2019/07/26

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Basic information
Public title Randomized Clinical Trial to Determine the Optimal Term of Nasogastric Decompression After Esophagectomy
Acronym Randomized Clinical Trial to Determine the Optimal Term of Nasogastric Decompression After Esophagectomy
Scientific Title Randomized Clinical Trial to Determine the Optimal Term of Nasogastric Decompression After Esophagectomy
Scientific Title:Acronym Randomized Clinical Trial to Determine the Optimal Term of Nasogastric Decompression After Esophagectomy
Region
Japan

Condition
Condition Esophageal Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of short-term vs prolonged nasogastric decompression for complication rate, postoperative hospital stays, and swallowing function after esophagectomy for esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of pneumonia
Key secondary outcomes Rate of anastomotic leakage, gastrointestinal bleeding
Rate of other adverse events
Rate of reinsertion of nasogastric tube
Rate of recurrent nerve paralysis
Swallowing function
Respiratory function
Postoperative hospital stays

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
Interventions/Control_1 Group A; Normal nasogastric tube decompression
(decannulation on the 7th postoperative day or at the time of contrast esophagram)
Interventions/Control_2 Group B; Short-term nasogastric tube decompression
(decannulation on the 1st postoperative day or at the time of extubation )
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 1) Scheduled for esophagectomy
2) Histologically proven esophageal cancer
3) Scheduled for a curative resection
4) Scheduled for right thoracotomy and laparotomy
5) One stage surgery
6) Gastric conduit is selected for reconstruction
7) Posterior mediatinal route is selected for reconstruction
8) Cervical approach is selected for anastomosis
9) severe complication
10) Written informed consent
Key exclusion criteria 1) Apparent infection and/or inflammation
2) Severe complication
3) During pregnancy or desire to bear children
4) Secondary reconstruction
5) Organ other than stomach is selected for reconstruction
6) Antethoracic route is selected for reconstruction
7) Intrapleural anastomosis
8) Over 35 in BMI
9) Under 17.5 in BMI
10) Attending physician's decision
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hirofumi
Middle name
Last name Kawakubo
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code 160-8582
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Email hkawakubo@z3.keio.jp

Public contact
Name of contact person
1st name Hirofumi
Middle name
Last name Kawakubo
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code 160-8582
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email hkawakubo@z3.keio.jp

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization School of Medicine, Keio University
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 Keio University School of Medicine, Ethics Committee
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.ac.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 慶應義塾大学病院 一般・消化器外科

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 25 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 Completed
Date of protocol fixation
2015 Year 05 Month 07 Day
Date of IRB
2015 Year 05 Month 01 Day
Anticipated trial start date
2015 Year 05 Month 25 Day
Last follow-up date
2019 Year 01 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
2015 Year 05 Month 13 Day
Last modified on
2019 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020319

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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