UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017553 |
|---|---|
| Receipt number | 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 13:19:56 |
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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
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
hkawakubo@z3.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020319
