UMIN-CTR Clinical Trial

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